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National Center for Health Research’s Public Comment on AHRQ Draft Review on Partial Breast Irradiation and Whole Breast Irradiation for Breast Cancer

July 29, 2022

We are writing to express our views on the AHRQ Draft Comparative Effectiveness Review comparing Partial Breast Irradiation (PBI) to Whole Breast Irradiation (WBI) as a treatment for early-stage breast cancer.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We agree with the AHRQ review that clinical trials provide sufficient evidence that PBI is a valuable treatment option for select patients with early-stage breast cancer. Patient outcomes for several types of PBI did not differ significantly from WBI patients in terms of ipsilateral breast recurrence (IBR), overall survival, and cancer-free survival at 5 and 10 years. However, IORT PBI patients did have higher levels of recurrence (IBR) than WBI patients, despite no difference in overall survival or cancer-free survival.  Overall, PBI patients have fewer acute adverse effects, lower transportation costs and days away from work, and fewer financial strains, making it a more convenient therapy option compared to WBI.  

However, there are numerous types of PBI, and the data are not adequate on the effectiveness of each one of them compared to WBI.  In addition, we agree with the AHRQ review that there is currently insufficient data to draw conclusions about the risks and benefits of different types of PBI compared to each other or to WBI for women who are diverse in terms of patient, tumor, and treatment characteristics. Outcomes at 15 and 20 years are also important to evaluate. For these reasons, more research is necessary to provide the most useful information to patients considering breast irradiation.

 

For more information, please contact Dr. Diana Zuckerman at dz@center4research.org. 

These machines to help people breathe were recalled a year ago. Many still use them

Emily Alpert Reyes, Los Angeles Times, June 23, 2022


In Rochester, N.Y., Diane Coleman has relied on a machine to help her stay alive, but she worries that it might be slowly undermining her health.

Her ventilator was among millions of breathing devices that Philips Respironics recalled last summer over safety concerns about numerous models of its ventilators, BiPAP and CPAP machines.

The reason: Polyester-based polyurethane foam used to muffle noise in those machines could degrade, giving off chemical gases and bits of black debris that could be swallowed or inhaled.

The possible risks: headaches, dizziness, nausea, irritated eyes and airways, and “toxic or cancer-causing effects,” according to federal regulators. The Food and Drug Administration put the recall in its most serious category, involving “a reasonable probability” that a product “will cause serious adverse health consequences or death.”

Yet a year later, many patients are still awaiting replacements — and some are using the recalled machines despite those possible risks.

Coleman said her machine underwent some initial repairs, but she is seeking a new one after federal regulators sought more safety testing of the replacement foam used for such fixes. The 68-year-old, who is president and chief executive of the disability rights group Not Dead Yet, has a form of muscular dystrophy and uses her ventilator roughly 22 hours each day.

She is nervous about how it could affect her, but “it’s not like I can stop using it.”

[….]

The devices are commonly used to treat sleep apnea, a disorder in which breathing is repeatedly interrupted during sleep, which can increase the risk of heart problems and leave people dangerously drowsy during the day. The FDA has advised patients who use the recalled CPAP or BiPAP machines to talk to their doctors about whether to stop.

Tom Wilson, who administers a Facebook support group for CPAP users affected by the recall, said he has read comments from group members who say they haven’t had any communication with Philips despite registering their devices with the company as much as a year ago. Some have paid out of pocket to get other devices.

[….]

“They’ve botched the whole thing,” said Dena Young, senior counsel at Berger Montague, who said that most of the people represented by her firm had not gotten a replacement or repair. As they wait, “some of them are still using the Philips because they don’t have a choice.”

Federal investigators have also taken interest: In April, Philips said the U.S. Department of Justice had subpoenaed the company in regards to events leading to the recall.

Consumer safety advocates argue that the halting process underscores the shortcomings of the recall system, which relies heavily on private companies to inform consumers and take action.

“It isn’t actually easy for the FDA to take products off the market,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit research center that has raised concerns about the safety of medical products. “It should be a lot easier than it is.”

But the actions that the FDA has taken so far in the Philips recall also show that the agency “has more power in recalls than they usually use,” Zuckerman said.

The FDA’s Center for Devices and Radiological Health told Philips last month that it was seeking to order the company to turn in a plan that could include not only repairing and replacing the recalled devices, but also providing refunds. In a November report, an FDA investigator found that Philips had failed to start taking appropriate action years earlier when the company first became aware the foam could be breaking down. Emails showed that the company was aware of “foam degradation issues” as early as October 2015, the FDA investigator found.

Within three years, more emails indicated that Philips had gotten more complaints about crumbling foam in ventilators and said that testing had confirmed that it broke down in high heat and high humidity, but the firm “made the decision not to change the design,” according to the FDA report in November. The FDA investigator noted that dating to 2008, Philips had gotten more than 222,000 consumer complaints that included keywords such as “contaminants, particles, foam, debris, airway, particulate, airpath and black.”

[….]

This year, the FDA found that Philips’ efforts to alert patients were insufficient, concluding that many patients were probably still unaware of the health risks nine months after the recall had begun. In March, it ordered the company to notify health professionals, device distributors and users of the recalled machines after estimating that only 50% of patients and consumers who had gotten recalled CPAPs and BiPAPs within the last five years had registered with the company for a replacement.

[….]

In Philadelphia, Meghann Luczkowski likewise worried about what would happen if Miles, her 8-year-old son, were switched to a different ventilator. Miles has a rare form of dwarfism that causes a “floppy airway” that needs to be reopened with mechanical ventilation. He had briefly been put on a different ventilator in the past but couldn’t maintain safe levels of oxygen and suffered “blue spells” in which his skin changed color.

His Philips machine has been “his lifeline,” allowing him to live at home with his family. But Luczkowski said they had begun noticing black buildup when they changed a filter in the machine.

“It’s a very scary thing to hear that the machine that keeps your child alive could suddenly be the thing that’s harming them,” Luczkowski said.

[….]

Concerns have continued to mount. From April 2021 through April 2022, federal regulators have gotten more than 21,000 reports about medical issues potentially tied to the recalled devices — or malfunctions likely to cause injuries if they recurred — including 124 reports linking them to deaths. Cancer has been a stated concern: Since 2020, more than 1,100 such reports about Philips CPAP or BiPAP machines have included the words “cancer,” “tumor” or “tumour,” said Madris Kinard, chief executive of Device Events, which gathers data to track problems with medical devices.

Those medical device reports, which can be submitted by health professionals and patients as well as manufacturers, do not require verification that the device caused the injury or death; Philips stressed that submitting such reports “is not evidence that the device caused or contributed to the adverse outcome or event.”

However, Zuckerman said “it’s assumed that a lot of deaths and other serious injuries don’t get reported at all.”

In La Quinta, Matthew P. Stone counts himself as relatively lucky. The 61-year-old, who had been using a Philips CPAP machine for sleep apnea, had been able to fall back on an old device from another manufacturer.

But Stone, like others, has been galled by the way the recall has played out. At one point, Stone said, he tried to lodge a complaint with federal regulators and was referred to a Southern California number that kept cutting out before he could leave a message.

“I am so incredibly disappointed,” he said, “at the lack of advocacy by anybody involved.”

To read the entire article, click here.

Who Should You Believe? A critique of the Aesthetic Society’s view of Breast Implant Illness

By Diana Zuckerman, PhD.


An article entitled “A Practical Guide to Managing Patients With Systemic Symptoms and Breast Implants” was published in the  Aesthetic Surgery Journal, (Volume 42, Issue 4, April 2022, Pages 397–407). This is a journal of the Aesthetic Society, which is the second largest association of plastic surgeons.  The authors are Patricia McGuire, MD, Daniel J Clauw, MD, Jason Hammer, MD, Melinda Haws, MD, and William P Adams, Jr, MD

There are many outrageous articles denying the existence of breast implant illness, but this may be the worst since it was published after major studies documented that breast implant illness exists.  The authors are prominent plastic surgeons who are members of the Aesthetic Society and/or the American Society of Plastic Surgeons (ASPS), which are the two major associations for plastic surgeons.  All but one of the authors have financial ties to companies that make breast implants.

The theme of the article is clearly stated in the summary: “Numerous studies have explored the possibility of an association between breast implants and systemic symptoms potentially linked to exposure to silicone. Some studies show no direct association whereas others provide insufficient scientific evidence to prove or disprove an association. Nonetheless, some patients with breast implants remain concerned about the possible role of their implants in systemic symptoms they may be experiencing. This paper provides a practical approach for plastic surgeons in managing patients with breast implants who present with systemic symptoms, including recommendations for patient counseling, clinical and laboratory assessment of symptoms, and/or referral. Integral components of patient counseling include listening attentively, providing unbiased information, and discussing the risks and benefits of options for evaluation and treatment.”

In reality, there are numerous studies in major medical journals that show a “direct association” between breast implant illness and diagnosed diseases with similar symptoms.  But the plastic surgeons who wrote the article are saying there is no evidence.  They are also saying that since patients mistakenly think BII is real, surgeons should assure them that although BII it is not proven, research is underway to study the issue.  That gaslighting is intended to show the patients that their surgeon is open-minded.

You might ask what is the evidence that the authors use to conclude that BII is not real?  To me as a researcher, this is the most mind-boggling part.  In addition to misquoting a 22-year old report from the Institute of Medicine – a report that is extremely outdated — and including a few individual case studies that just happen to all illustrate the authors’ view that breast implant illness isn’t real — the authors made several major errors:

#1.  They state that “In 2019, an FDA advisory panel on breast implant safety determined that there is currently insufficient evidence of a causal relationship between breast implants and the diagnosis of rheumatologic disease or [connective tissue disease].” They footnote this statement with a document that was written by the FDA before the FDA advisory panel met in 2019 and which did not draw any such conclusions.

#2. They state that “a number of epidemiological studies taken together are felt by many experts in the field to represent convincing evidence that there is no link between SBIs and auto-immune diseases.” The authors support that statement by listing 9 articles that they do not discuss. Almost all of the articles were funded by implant manufacturers and/or plastic surgeons, and 3 were published more than 20 years ago, based on poorly designed studies. One study was described as a study of 55,000 women, but in reality a large percentage of the patients dropped out before the study was completed.  Most outrageous of all, the last 2 studies listed actually concluded the opposite to what the plastic surgeons claimed:  The Israeli study and the Baylor study that both concluded that several autoimmune diseases with symptoms similar to BII are significantly increased after women get breast  implants.

#3.  They mistakenly conclude that since women with saline breast implants also report BII symptoms, the symptoms are not related to the silicone shell.  This is a ridiculous statement since all breast implants have silicone shells.

#4.  In contrast to their uncritical acceptance of poorly designed and biased studies funded by implant manufacturers and surgeons with financial ties to those implant makers, when the authors briefly mention studies showing that women with BII symptoms that improve after their implants are removed, they speculate (without evidence) that such improvement might be temporary.  It is notable that they didn’t even mention the 2021 study by Dr. Feng and her colleagues, which showed significant improvement in lung function after explant surgery.  That is no accident, since this Aesthetic Society article was published many months later.

There are too many other careless errors in the article to list them all.  I can’t help but wonder if the authors read any of the studies they were supposedly quoting.  While urging plastic surgeons to pretend to be open-minded, the authors are anything but.  They repeatedly misrepresent research findings in order to support their biased view that the symptoms of breast implant illness are not caused by breast implants.

In summary: This article makes it clear that the Aesthetic Society is encouraging their members to “gaslight” patients with BII, rather than help them get explanted.  Women who are seeking well-informed plastic surgeons should avoid the authors and think twice before believing anything they hear from plastic surgeons that belong to the Aesthetic Society, since the journal is published by that medical group.

NCHR Comments on the MDUFA V Commitment Letter

April 21, 2022

The National Center for Health Research (NCHR) appreciates the opportunity to provide public comments on the Medical Device User Fee Amendments (MDUFA) V Commitment letter, and to express our substantial concerns with the overall process as well as the shortcomings of the Commitment letter.

NCHR is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues and health policies, with particular focus on ensuring that treatments are safe and effective for patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

The negotiations between the Food and Drug Administration (FDA) and medical device industry are unlike regulatory processes at other federal agencies. The typical process is more transparent and includes meaningful stakeholder engagement and feedback from the public. The fact that the very industries being regulated by the FDA meet behind closed doors with FDA staff to negotiate a Commitment Letter, with no members of the public allowed to be in the room or have access to a transcript or recording, raises important questions about why industry has more say in FDA policies and practices than other Stakeholders. We previously pointed out the lack of transparency and the lack of meeting minutes, which we were told would be publicly available – but weren’t.

This proposed Commitment letter, although late, has already been delivered to Members of Congress. The House Energy & Commerce Subcommittee on Health held a hearing on March 30, 2022, on the contents of the proposed Commitment Letter. It seems disingenuous to request public feedback, at this week’s meeting or in writing, at this late point in the process.

In addition to the lack of transparency in the process and lack of public representation in negotiations between FDA and the medical device industry, the Commitment Letter fails to include any performance measures specifically linked to patient safety. Given the lack of safety or effectiveness data prior to clearance or approval of more than 95% of medical devices, post-market surveillance is crucially important. And yet, the Commitment Letter provides no requirement for financial support for post-market monitoring of studies or MAUDE reports, putting patients at risk for years to come.

Despite our lack of confidence in the FDA’s negotiated agreement with industry, below are our specific recommendations for your consideration as you finalize the MDUFA V Commitment Letter:

  1. Include performance measures tied to device safety, such as total time to recall a device following adverse event reporting.
  2. Direct any additional funds earned by FDA for meeting premarket performance goals to post-market surveillance activities.
  3. The total product life cycle advisory program (TAP) should include post-market activities to truly capture the full life cycle. This is becoming even more important as devices become more complex and technology rapidly changes. User fees should be used to support technology systems to monitor devices. Based on the description in the proposed Commitment Letter, TAP would focus on early communication with industry to troubleshoot potential issues with applications, but not to monitor the devices once they are on the market.
  4. Diversity and accessibility performance measures should be included in the proposed Commitment Letter.
    1. Industry could be provided a discount on fees if certain diversity performance goals are met in a PMA application.
    2. Industry should be required to include a detailed plan on potential device recalls. The plan should include how information will be shared with patients and what steps will be taken to ensure the information is presented in a timely manner and accessible formats.

When Congress required that stakeholders have the opportunity to participate in the MDUFA V reauthorization process, they intended that our participation would be meaningful. This is the final opportunity for the FDA to fulfill that obligation in MDUFA V.

NCHR Letter to Members of the Board of the Los Gatos Union School District on Artificial Turf and Playgrounds

National Center for Health Research, April 18th, 2022


Dear Superintendent Johnson and Members of the Board of the Los Gatos Union School District:

I am writing to share scientific information about artificial turf and playground surfaces, which I am confident will help you determine what is best for the children and adults in your community.

As President of the National Center for Health Research, I am writing at the request of many of your constituents to share the information we have provided to Members of Congress, state and federal agencies, state and local legislators, parents, and others who want to ensure that our children are not exposed to dangerous chemicals when they play on artificial turf or playgrounds. Our nonprofit think tank is located in Washington, D.C. Our scientists, physicians, and health experts conduct studies and scrutinize research. Our goal is to explain scientific and medical information that can be used to improve policies, programs, services, and products.

We understand that these issues are hotly debated, but some information is more accurate than others.  For example, if you look at the maintenance contract for an artificial field, you will see that it needs to be watered regularly to prevent it from becoming dangerously hard and to keep its warranty in place.  In other words, grass fields and artificial turf fields both require water, but well-designed grass fields will last much longer and be more cost-effective.

In the last few years, scientists have learned more about lead and PFAS in artificial turf, as well as the risks of some of the newer infill materials that are available to replace tire crumb. Tire crumb has well-known risks, containing chemicals that have the potential to increase obesity; contribute to early puberty; cause attention problems such as ADHD; exacerbate asthma; and eventually cause cancer. However, the plastic grass itself has dangerous levels of lead, PFAS, and other toxic chemicals as well.  PFAS are of particular concern because they enter the body and the environment as “forever chemicals,” which means that they are not metabolized and do not deteriorate, accumulating over the years. Replacing tire waste with silica, zeolite, and other materials also has substantial risks.  For example, it is well known that “particulate matter” can cause lung problems and eventually cause lung cancer.  For that reason, silica and zeolite are of great concern.

Federal agencies such as the EPA and the U.S. Consumer Product Safety Commission have been investigating the safety of these products. Despite claims to the contrary, none have concluded that artificial turf is safe. Although the Trump Administration’s EPA stated that there was no conclusive evidence that the levels of chemicals in artificial turf was harmful to children, they explained that their research was based on assumptions and that they had not conducted or reviewed studies of children exposed to artificial turf.

Lead

As you probably know, the American Academy of Pediatrics states that no level of lead exposure should be considered safe for children, because lead can cause cognitive damage even at low levels. Some children are more vulnerable than others, and that can be difficult or even impossible to predict. Since lead has been found in tire crumb as well as in new synthetic rubber, it is not surprising

that numerous artificial turf fields and playground surfaces made with either tire crumb or “virgin” rubber have been found to contain lead. However, the Centers for Disease Control and Prevention (CDC) also warns that the “plastic grass” made with nylon or some other materials also contains lead. Whether from infill, plastic grass, or rubber playground surfaces, the lead doesn’t just stay on the surface. With wear, the materials turn to dust containing lead and other chemicals that is invisible to the eye and is inhaled by children when they play.

Why are chemicals that are banned from children’s toys allowed in artificial turf and rubber playground surfaces?

Synthetic rubber and plastic are made with different types of endocrine (hormone) disrupting chemicals (also called EDCs). There is very good evidence regarding these chemicals in tire crumb, based on studies done at Yale and by the California Office of Environmental Health Hazard Assessment (OEHHA).However, rubber playground surfaces contain many of the same dangerous chemicals as tire crumb, since they are very similar materials, all made from petroleum.

A 2018 report by Yale scientists detected 92 chemicals in samples from 6 different artificial turf companies. Unfortunately, the health risks of most of these chemicals had never been studied. However, 20% of the chemicals that had been tested are classified as probable carcinogens and 40% are irritants that can cause asthma or other breathing problems, or can irritate skin or eyes.2

There are numerous studies indicating that endocrine-disrupting chemicals (also called hormone-disrupting chemicals) found in rubber and plastic cause serious health problems. Scientists at the National Institute of Environmental Health Sciences (which is part of NIH) have concluded that unlike most other chemicals, hormone-disrupting chemicals can be dangerous at very low levels, and the exposures can also be dangerous when they combine with other exposures in our environment.

That is why the Consumer Product Safety Commission has banned numerous endocrine-disrupting chemicals from toys and products used by children. The products involved, such as pacifiers and teething toys, are banned even though they would result in very short-term exposures compared to artificial turf or playground surfaces.

A report warning about possible harm to people who are exposed to rubber and other hormone disrupting chemicals at work explains that these chemicals “can mimic or block hormones and disrupt the body’s normal function, resulting in the potential for numerous health effects. Similar to hormones, endocrine-disrupting chemicals can function at very low doses in a tissue-specific manner and may exert non-traditional dose–response because of the complicated dynamics of hormone receptor occupancy and saturation.”3

Studies are beginning to demonstrate the contribution of skin exposure to the development of respiratory sensitization and altered pulmonary function. Not only does skin exposure have the potential to contribute to total body burden of a chemical, but also the skin is a highly biologically active organ capable of chemical metabolism and the initiation of a cascade of immunological events, potentially leading to adverse outcomes in other organ systems.

Scientific Evidence of Cancer and Other Systemic Harm

It is essential to distinguish between evidence of harm and evidence of safety. Companies that sell and install artificial turf often claim there is “no evidence children are harmed” or “no evidence that the fields cause cancer.” This is often misunderstood as meaning the products are safe or are proven to not cause harm. Neither is true.

It is true that there no clear evidence that an artificial turf field has caused specific children to develop cancer. However, the statement is misleading because it is virtually impossible to prove any chemical exposure causes one specific individual to develop cancer.

As an epidemiologist, I can also tell you that for decades there was no evidence that smoking or Agent Orange caused cancer. It took many years to develop that evidence, and the same will be true for artificial turf.

I have testified about the risks of these materials at the U.S. Consumer Product Safety Commission as well as state legislatures and city councils. I am sorry to say that I have repeatedly seen and heard scientists paid by the turf industry and other turf industry lobbyists say things that are absolutely false. They claim that these products are proven safe (not true) and that federal agencies have stated there are no health risks (also not true).

However, we know that the materials being used in artificial turf and rubber playground surfaces contain carcinogens, and when children are exposed to those carcinogens day after day, week after week, and year after year, they increase the chances of our children developing cancer, either in the next few years or later as adults. That should be adequate reason not to install them in your community. That’s why I have spoken out about the risks of artificial turf in my community and on a national level. The question must be asked: if they had all the facts, would your community choose to spend millions of dollars on fields that are less safe than well-designed natural grass fields?

Dangerously Hot and Hard Fields

When the weather is warm and/or sunny, it is usually quite pleasant to be outside – as long as you aren’t on artificial turf or an outdoor rubber surface. Even when the temperature above the grass is 80 degrees Fahrenheit, artificial turf can reach 150 degrees or higher. Obviously, a 90 degree day is likely to be even hotter than 150 degrees on turf. That can cause “heat poisoning” as well as burns.

Artificial turf fields get hard as well. Turf companies recommend annual tests at 10 locations on each turf field, using something called a Gmax score. A Gmax score over 200 is considered extremely dangerous, and it is considered by industry to pose a death risk. However, the synthetic turf industry and American Society for Testing and Materials (ASTM), suggest scores should be even lower — below 165 to ensure safety comparable to a grass field. Will your community pay to have these tests conducted annually on all your public artificial turf fields?

The hardness of natural grass fields is substantially influenced by rain and other weather; if the field gets hard, rain or watering will make it safe again. In contrast, once an artificial turf field has a Gmax score above 165, it needs to be replaced because while the scores can vary somewhat due to weather, the scores will inevitably get higher because the turf will get harder. Gmax testing involves testing 10 different areas of a playing fields, to make sure all are considered safe.  Some officials average those 10 scores to determine safety; however, experts explain that is not appropriate. If a child (or adult) falls, it can be at the hardest part of the field, which is why safety is supposed to be determined by the score of the hardest part of the field.

Environmental Issues

In addition to the health risks to school children and athletes, approximately three tons of infill materials migrate off of each synthetic turf field into the greater environment each year. About 2-5 metric tons of infill must be replaced every year for each field, meaning that tons of the infill have migrated off the field into grass, water, and our homes.4 The fields also continuously shed microplastics as the plastic blades break down.5,6 These materials may contain additives such as PAHs, flame retardants, and UV inhibitors, which can be toxic to marine and aquatic life. Microplastics are known to migrate into the oceans, the food chain, and drinking water, and they can absorb and concentrate other toxins from the environment.7,8,9

Synthetic surfaces also create heat islands.10,11 In contrast, organically managed natural grass saves energy by dissipating heat, cooling the air, and reducing energy to cool nearby buildings. Natural grass and soil protect groundwater quality; biodegrade polluting chemicals and bacteria; reduce surface water runoff; abate noise; and reduce glare.12

Alternative Infills

Envirofill artificial turf fields are advertised as “cooler” and “safer,” but our research indicates that these fields are still at least 30-50 degrees hotter than natural grass. Envirofill is composed of materials resembling plastic polymer pellets (similar in appearance to tic tacs) with silica inside. Silica is classified as a hazardous material according to OSHA regulations, and the American Academy of Pediatrics specifically recommends avoiding it on playgrounds. The manufacturers and vendors of these products claim that the silica stays inside the plastic coating. However, sunlight and the grinding force from playing on the field breaks down the plastic coating. For that reason, even the product warranty admits that only 70% of the silica will remain encapsulated. The other 30% can be very harmful as children are exposed to it in the air as particulate matter that can harm the lungs.

In addition, the Envirofill pellets and some other infill have been coated with an antibacterial called triclosan. Triclosan is registered as a pesticide with the EPA, and the FDA has banned triclosan from soaps because manufacturers were not able to prove that it is safe for long-term use. Research shows a link to liver and inhalation toxicity and hormone disruption. The manufacturer of Envirofill says that the company no longer uses triclosan, but they provide no scientific evidence that the antibacterial they are now using is any safer than triclosan. Microscopic particles of this synthetic turf infill will be inhaled by children, and visible and invisible particles come off of the field, ending up in shoes, socks, pockets, and hair.

In response to the concerns of educated parents and government officials, other new materials are now being used for infill instead of tire crumb and other very controversial materials. However, all the materials being used (such as zeolite, corn husks, and Corkonut) have raised concerns, and none are proven to be as safe or effective as well-designed grass fields.

Conclusions

There have never been any safety tests required prior to sale that prove that any artificial turf products are safe for children who play on them regularly. In many cases, the materials used are not publicly disclosed, making independent research difficult to conduct. None of these products are proven to be as safe as natural grass in well-constructed fields.

I have cited several relevant scientific articles on artificial turf in this letter, and there are numerous studies and growing evidence of the harm caused by these synthetic materials. I would be happy to provide additional information upon request (dz@center4research.org).

I am not paid to write this statement. I am one of the many parents and scientists who are very concerned about the impact of artificial fields on our children. Your decision about artificial turf and playground surfaces can save lives and improve the health of children in your community.  You owe it to your community to make sure that you know the risks of artificial turf and do all you can to protect your children from both the known risks and the suspected risks. Your decisions about artificial turf will be cited by other communities, making it even more important that your decision is based on scientific evidence, not on sales pitches by individuals with conflicts of interest.

Officials in communities all over the country have been misled by artificial turf salespeople. They were erroneously told that these products are safe. On the contrary, there is clear scientific evidence that these materials are harmful. The only question is how much exposure is likely to be harmful to which children? We should not be willing to take such a risk. Our children deserve better.

Sincerely,

Diana Zuckerman, PhD

President

References

  1. State of California-Office of Environmental Health Hazard Assessment (OEHHA), Contractor’s Report to the Board. Evaluation of Health Effects of Recycled Waste Tires in Playground and Track Products. January 2007. http://www.calrecycle.ca.gov/publications/Documents/Tires%5C62206013.pdf
  2. Benoit G, Demars S. Evaluation of organic and inorganic compounds extractable by multiple methods from commercially available crumb rubber mulch. Water, Air, & Soil Pollution. 2018;229:64. https://doi.org/10.1007/s11270-018-3711-7
  3. Anderson SE and Meade BJ. Potential Health Effects Associated with Dermal Exposure to Occupational Chemicals. Environmental Health Insights. 2014; 8(Suppl 1):51–62. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4270264/
  4. York T. Greener grass awaits: Environmental & fiscal responsibility team up in synthetic turf. Recreation Management. February 2012. http://recmanagement.com/feature_print.php?fid=201202fe02
  5. Magnusson K, Eliasson K, Fråne A, et al. Swedish sources and pathways for microplastics to the marine environment, a review of existing data. Stockholm: IVL- Swedish Environmental Research Institute. 2016. https://www.naturvardsverket.se/upload/miljoarbete-i-samhallet/miljoarbete-i-sverige/regeringsuppdrag/utslapp-mikroplaster-havet/RU-mikroplaster-english-5-april-2017.pdf
  6. Kole PJ, Löhr AJ, Van Belleghem FGAJ, Ragas AMJ. Wear and tear of tyres: A stealthy source of microplastics in the environment. International Journal of Environmental Research Public Health. 2017;14(10):pii: E1265. https://www.ncbi.nlm.nih.gov/pubmed/29053641/
  7. Kosuth M, Mason SA, Wattenberg EV. Anthropogenic contamination of tap water, beer, and sea salt. PLoS One. 2018,13(4): e0194970. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895013/
  8. Oehlmann J, Schulte-Oehlmann U, Kloas W et al.  A critical analysis of the biological impacts of plasticizers on wildlife. Philosophical Transactions of the Royal Society B. 2009;364:2047–2062. http://rstb.royalsocietypublishing.org/content/364/1526/2047
  9. Thompson RC, Moore CJ, vom Saal FS, Swan SH. Plastics, the environment and human health: Current consensus and future trends. Philosophical Transactions of the Royal Society B. 2009;364:2153–2166. https://royalsocietypublishing.org/doi/full/10.1098/rstb.2009.0053
  10. Thoms AW, Brosnana JT, Zidekb JM, Sorochana JC. Models for predicting surface temperatures on synthetic turf playing surfaces. Procedia Engineering. 2014;72:895-900. http://www.sciencedirect.com/science/article/pii/S1877705814006699
  11. Penn State’s Center for Sports Surface Research. Synthetic turf heat evaluation- progress report. 012. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
  12. Stier JC, Steinke K, Ervin EH, Higginson FR, McMaugh PE. Turfgrass benefits and issues. Turfgrass: Biology, Use, and Management, Agronomy Monograph 56. American Society of Agronomy, Crop Science Society of America, Soil Science Society of America. 2013;105–145. https://dl.sciencesocieties.org/publications/books/tocs/agronomymonogra/turfgrassbiolog

 

She’s the reason Arizona has a law requiring surgeons to warn patients about the dangers of breast implants

Bianca Buono and Katie Wilcox, Arizona News 12 NBC: February 22, 2022


PHOENIX — Migraines. Headaches. Insomnia. Difficulty breathing. Trouble swallowing.

Robyn Towt survived three bouts with cancer. But it was breast implants that made her the sickest.

“I couldn’t figure out what was wrong with me,” Towt said.

At first, it was a mystery. She had recently survived breast cancer then had a double mastectomy with breast reconstruction. The cancer was gone, so why was she feeling so badly?

“My entire team of doctors failed me,” Towt said.

Towt said her team of doctors never mentioned that her breast implants could cause those side effects. She started doing her own research, desperate to figure out why she was feeling this way.

[….]

Undisclosed risks

Diana Zuckerman, president of the National Center for Health Research, has been outspoken about the dangers of implants for years.

“One of the things that’s been so tragic for all these years is how many women got sicker and sicker and sicker, year after year after year, going to doctors saying what’s wrong with me and the doctor saying, you know, I don’t know, do these tests and try to figure it out,” Zuckerman said.

“And then they finally discover on social media, that there are tens of thousands of women with exactly the same health problems they have, who also happen to have breast implants, and then they get their implants out, and they get better.”

Zuckerman has been pushing for acknowledgment from the FDA that breast implant illness exists, advocating for more research around what exactly causes it and pushing for transparency when it comes to the risks.

She says the FDA took a step in the right direction last year when the agency announced breast implants would be equipped with a black box warning.

The FDA boxed warning informs patients of the following:

  • Breast implants are not considered lifetime devices
  • The chance of developing complications increases over time
  • Some complications will require more surgery
  • Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
  •  BIA-ALCL occurs more commonly in patients with textured breast implants than smooth implants, and deaths have occurred from BIA-ALCL
  • Breast implants have been associated with systemic symptoms

“They’re going to have what’s called a black box warning, that’s like the kind of warning you see on cigarette packages that tell you cigarettes can kill you,” Zuckerman said.

Arizona’s first-of-its-kind bill

Even still, that warning wasn’t always relayed by plastic surgeons to patients. That’s why lawmakers in Arizona decided to take matters into their own hands.

“We have to do something,” said state Sen. Michelle Ugenti-Rita.

Consultations for breast augmentations look different now in Arizona than they did a year ago.

That’s because a first-of-its-kind bill has passed in Arizona created to protect women against a badly kept secret involving breast augmentation surgery: breast implant illness.

“I was shocked to learn that there were so many women with very very similar stories and experiences. And yet there was nothing being done from the medical community’s perspective and point of view,” Ugenti-Rita said.

[….]

To read the entire article click here.

What You Need to Know About Breast Implants

Diana Zuckerman, PHD; Elizabeth Naglin-Anderson, MA; and Elizabet Santoro, RN, MPH, National Center for Health Research


In 2020, fewer than 194,000 women and teenagers underwent surgery to have their breasts enlarged with silicone or saline implants, a 33% decrease compared to 2019.  In addition, more than 137,000 breast cancer patients had reconstruction after mastectomy in 2020, often with implants.1 While the popularity of breast augmentation had tripled between 1997, when there were just over 101,000 of these procedure,2  to 2017 when over 300,000 breast augmentations were performed1, recent trends show that fewer women are opting for augmentation.

There were also 59,043 implant removal procedures in 2020, including augmentation and reconstruction patients, compared to 54,539 in 2019 and 48,385 in 20181 . The increasing number of women removing their implants can be attributed to several factors, including news stories highlighting the risks of breast implants, the growing mass media and social media presence of patient advocates, Allergan’s recall of their BIOCELL textured breast implants in 2019 and efforts to notify women of the recall, and several insurance companies expanding their coverage to include women whose textured implants were recalled.

However, debate continues to swirl about the safety of breast implants. Here are the facts about what is known and not known about the risks of breast implants.

History of Implants in the US

Breast implants made with silicone envelopes and filled with silicone gel or saline (salt water) were first sold in the United States in the 1960s, but sales were relatively slow until the 1980s. By 1990, however, almost one million women had undergone breast implant surgery, even though no safety studies had been published. Most of those women had silicone gel breast implants, which the plastic surgeons preferred.

Although most medical products must be proven safe and effective before they can be sold in the U.S., that was not true for implanted medical devices sold before 1976.  The Food and Drug Administration (FDA) did not require that companies selling silicone breast implants prove that their implants were safe until 1991 – after they had been in use for almost three decades. For the first time, the media started to report about women with implant problems, and quoted doctors who were concerned about implant safety. When the studies were provided to the FDA, the safety data were found to be inadequate to warrant FDA approval.

The FDA did not require implant makers to prove that their saline implants were safe until 2000, when, despite high complication rates, the FDA approved saline breast implants for the first time.

Silicone gel breast implants were approved for the first time in November 2006. Between 1992 and 2006, silicone implants were restricted to clinical trials that were primarily for cancer patients and women with broken implants. The FDA required that patients be informed that the implants were not approved by the FDA and to be regularly evaluated by their plastic surgeons as part of the study, in order to provide safety data intended to help all women with gel implants. Unfortunately, there was no enforcement of that requirement and women who were enrolled in these studies to enable them to get breast implants were often not studied after the surgery.

Silicone gel breast implants made by two manufacturers were approved in November 2006, and gel implants made by one/two other manufacturers were approved subsequently.  There are still restrictions, however. For example, they are only approved for women over the age of 22, because younger women are still developing physically and emotionally and probably would not fully understand the risks.

In 2011, the FDA began tracking cases of a cancer of the immune system linked to textured breast implants, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Over the next several years, as studies were completed, FDA and medical experts recognized that rather than just being “possibly associated” with ALCL, breast implants caused ALCL, and that the risk was highest among women with textured breast implants. In 2019, Allergan recalled their BIOCELL textured implants worldwide following growing evidence of the greater risk of BIA-ALCL for women with those implants.  At the time of the recall, the FDA reported that 573 cases of BIA-ALCL worldwide had been reported since 2011, and this was increased to 733 in 2020.

What Are the Known Risks?

Reports of complications among women with implants have been published in medical journals and discussed at public FDA meetings. There are a number of short-term and long-term risks that any woman thinking about getting breast implants or about removing or replacing older implants needs to be aware of.

“Local complications” refer to problems that occur in the breast area that are obviously related to the breast implants or the surgery. Common complications include infection and other surgical risks, chronic breast pain, breast or nipple numbness, capsular contracture, breakage and leakage, necrosis (skin death), the need for additional surgery, and “cosmetic” problems (such as dissatisfaction with how the breast looks with the implant).

Studies of saline breast implants and silicone gel breast implants conducted by implant manufacturers have shown that within the first three years, approximately three out of four reconstruction (breast cancer) patients and almost half of first-time augmentation patients experienced at least one local complication – such as pain, infection, hardening, or the need for additional surgery.3

For example, among reconstruction patients:

  • 46% of women with silicone gel implants and 21% with saline implants underwent at least one re-operation within three years;
  • 25% of silicone patients and 8% of saline patients had implants removed; and
  • 6% of silicone patients and 16% of saline patients experienced breast pain.4

Complication rates were lower, but still substantial, for augmentation patients. The FDA has a consumer handbook with descriptions of common complications as well as photographs, available to consumers here.

Among all reported complications related to breast implants, BIA-ALCL has been the most concerning, especially as reported cases continue to rise worldwide.  Since many physicians do not report problems with medical devices, reports to the FDA are considered “the tip of the iceberg.”  Therefore, although rare, it seems that BIA-ALCL is not “very rare.” In Australia, which can track medical problems from any kind of implants better than the tracking of implants in the U.S., they estimate that BIA-ALCL affects one woman per 1,000 with breast implants.5 The estimates were much lower in the U.S., but there is no reason to think BIA-ALCL is less likely to develop in women in the U.S.  Given the dramatic increase in diagnoses in recent years, it is clear that BIA-ALCL was under-diagnosed and under-reported for many years.

In addition to the risks from anesthesia, surgical risks include infection and hematoma (blood collecting around an implant), both of which can range from mild to severe. Surgical risks are highest immediately around the time of surgery, but complications can require additional surgery later, which will have similar risks. A woman may need to face these surgical risks several times if she needs surgery to correct implant problems or has broken or damaged implants replaced with new ones.

Common local complications include loss of nipple sensitivity or painfully sensitive nipples. Some women are dissatisfied with the cosmetic results of breast implants, because their breasts look or feel unnatural or asymmetrical, or they can hear a “sloshing sound” from saline-filled implants. Problems like these can interfere with sexual intimacy.

Scar tissue that forms around any implant or foreign body can become hard or tight around the implant. This common problem is called capsular contracture. The scar tissue is inside the body, but it can cause the breasts to become very hard and misshaped, and it leads to discomfort that ranges from mild to severely painful.

Researchers have shown that bacteria or mold can grow in saline implants, and have expressed concerns about the bacteria or mold being released into the body if the implant breaks.6 What effect that might have on a woman, or a nursing baby, has not been studied.

What Happens When Implants Break?

All breast implants will eventually break, but it is not known how many years the breast implants that are currently on the market will last. Studies of silicone breast implants suggest that most implants last 7-12 years, but some break during the first few months or years, while others last more than 15 years.

In a study conducted by FDA scientists, most women had at least one broken implant within 11 years, and the likelihood of rupture increases every year.7 Silicone migrated outside of the breast capsule for 21% of the women, even though most women were unaware that this had happened.

Implant makers were required to study breakage and provide their studies to the FDA.  Short-term studies of today’s saline implants suggest that between 3-9% break within the first three years, and one implant manufacturer’s study of their silicone gel implants found that between 3-20% break within three years.3,8 A Danish study of ruptured silicone gel implants suggests that most implants last for ten years, but by the time they are 11-20 years old, most will break, and after 20 years the few that are still intact will break.9

Many women with silicone gel implants are unaware that their implants are broken or leaking.  Plastic surgeon Dr. Scott Spear and the former director of FDA’s Office for Women’s Health, Dr. Susan Wood, point out that “magnetic resonance imaging is the most accurate way to detect a rupture…Mammograms are often inaccurate in detecting rupture, and if an implant is already broken, the pressure from a mammogram could cause the silicone gel from the implant to leak outside the capsule.”10

Silicone Migration. Research has shown that silicone gel in implants can break down to liquid silicone at normal body temperatures, and there are reports of silicone leakage and migration from implants to the lymph nodes and other organs.11 What happens if liquid silicone migrates to the lungs, liver, or other organs? A study published by the Royal Academy of Medicine in Scotland found that a woman with a broken silicone gel implant in her calf was coughing up silicone identical to the kind in her implant.12 This has potentially serious implications for women with breast implants, since silicone gel breast implants are considerably larger and closer to the lungs than calf implants.

Do Breast Implants Make Women Sick?

A more controversial question is whether breast implants cause diseases or illnesses, in addition to ALCL and problems in the breast area.

Autoimmune, Connective tissue and Other Painful Diseases and Conditions.  Several reports published since the late 1990’s concluded that there is no evidence that implants cause systemic disease.13,14 These reports, however, often relied on research that focused on painful and autoimmune conditions and diseases in women who had implants for a relatively short time — ranging from a few months to a few years. Since these diseases may take many years to develop and be diagnosed, studies that include women who had implants for such a short time cannot be used to determine whether or not breast implants increase the long-term risks of getting these diseases.

Studies conducted after those initial reports were published indicated that implants might be linked to a number of diseases. For example, FDA scientists conducted a study of women who had silicone gel breast implants for at least seven years and found that those with implants that were leaking outside the scar tissue surrounding the implant were significantly more likely to report a diagnosis of at least one of several painful and debilitating diseases, such as fibromyalgia, polymyositis, Hashimoto’s thyroiditis, mixed connective-tissue disease, or pulmonary fibrosis.15  The risk of these diseases remained even after statistically controlling for patient’s age, implant age, and implant manufacturer.

Do implant patients who have autoimmune symptoms feel better if their implants are removed?  A study of 95 women who had silicone gel-filled breast implants and rheumatologic symptoms such as joint pain, found that the symptoms improved in 97% (42 of 43) of the women who had their breast implants removed. In contrast, rheumatologic symptoms worsened in 96% (50 of 52) of the women who did not have their implants removed.16 In addition, a university researcher has reported that silicone stimulates an immune response, and cellular analyses indicate that these responses are associated with atypical forms of connective tissue disease.17

A study of Danish women who had breast implants for an average of 19 years found that they were significantly more likely to report fatigue, Raynaud-like symptoms (white fingers and toes when exposed to cold), and memory loss and other cognitive symptoms, compared to women of the same age in the general population.18

Despite reporting that women with implants were between two and three times as likely to report those symptoms, the researchers, who were funded by a silicone manufacturer, concluded that long-term exposure to breast implants “does not appear to be associated with” autoimmune “symptoms or diseases.” However, the symptoms they reported can be from autoimmune diseases.

A report summarizing studies of breast implants was conducted by researchers hired by Tufts University and funded by The Plastic Surgery Foundation, which was supported by the 3 U.S. implant manufacturers.  This summary is notable for barely mentioning the studies quoted above.19

A study by MD Anderson Cancer Center researchers that was published in September 2018 in the medical journal Annals of Surgery, concluded that “silicone implants are associated with an increased risk of certain rare harms” and that further study is needed “to inform patient and surgeon decision-making.”20 The study included more than 100,000 women with implants, but is based on data from flawed studies conducted by two implant companies, Mentor and Allergan. Nevertheless, it is important to note that the researchers found that the risks of certain autoimmune diseases increased by 800% (Sjogren syndrome), 700% (scleroderma), and 600% (arthritis) for the women with Mentor silicone gel breast implants compared to the general population of women of the same age and demographics.  Stillbirths increased by 450% in the women who became pregnant.  Other autoimmune and rare diseases were also significantly higher among women with Mentor silicone gel implants.  These diagnoses were also statistically significantly higher for women with Allergan implants compared to the general population of women of similar demographics. Given the large percentage of women who were not in the study for more than 1 year, it is not possible to know how representative these findings are. However, these results raise important questions, especially now that it is known that breast implants can cause cancer of the immune system.

Will Explant Surgery Help Women with Breast Implant Illness Recover?

study published in 2020, conducted by Dr. Lu Jean Feng and her colleagues, also shows the risk of breast implant illness for women with breast implants, by studying the impact of explant surgery on women with breast implant illness symptoms. This study of 750 women focused on 11 symptoms: 1) numbness and tingling in the extremities; 2) joint and/or muscle pain; 3) hair loss; 4) memory loss/cognitive problems; 5) dry eyes and/or blurred vision; 6) chronic fatigue; 7) breast pain; 8) rashes and/or hives; 9) food sensitivity/intolerance; 10) flu-like symptoms and/or low-grade fever; 11) difficulty breathing.  After the women had their implants removed, most reported a significant improvement in their health within 30 days. This was true for women with either silicone gel implants or saline implants21. Not all the women had all the symptoms prior to getting their implants removed, and some reported worse symptoms than others.  After the women had their implants removed, the women reported a statistically significant improvement in their health within 30 days. The highly significant results showed that this was a real difference, that did not happen by chance.  Improvements in symptoms occurred for women with either silicone gel implants or saline implants.21

A study published in 2021 by many of the same physicians and researchers focused only on women who had reported “trouble breathing” prior to having their implants removed.22  There were 53 women in the study, and they had implants for an average of 12 years, including silicone or saline implants.  After their implants were removed, 100% of the women reported improvement in breathing.  Even more important, the physicians used 6 objective measures of “pulmonary function” that were compared before and after their implants were removed.  On half of those 6 measurements, the women showed statistically significant improvement.  In other words, the women reported improvement and those results were consistent with the evaluations conducted by the doctors using medically established objective measures indicating breathing difficulties.22

Do Breast Implants Increase the Chances of Developing Other Types of Cancer?

As mentioned above, breast implants can cause a type of cancer of the immune system called ALCL. There are also unanswered questions about cancer and implants. A study by National Cancer Institute (NCI) scientists found a 21% overall increased risk of cancer for women who had implants for at least seven years, compared with women of the same age in the general population.23 The increase was primarily due to an increase in brain, respiratory tract, cervical, and vulvar cancers. More research is needed to draw any conclusions, however.

There is no research evidence that implants cause breast cancer. However, implants can interfere with detection of breast cancer.

Mammograms have been shown to detect breast cancer earlier, potentially saving lives as well as saving women from needed mastectomies.  There are several ways in which implants have the potential to delay detection of breast cancer:

  • Although mammography can be performed in ways that minimize the interference of the implants, approximately 55 percent of breast tumors will be hidden in women with implants.24
  • FDA scientists report that silicone or saline implants can rupture when women undergo mammograms, and for this reason, women who fear implant rupture may forego mammograms.25
  • The accuracy of mammograms tends to decrease as the size of the implants increase in proportion to the size of the woman’s natural breast.

Patients have reported that their implants delayed their breast cancer diagnosis.24  Research findings have been inconsistent, but a 2013 Canadian systematic review of 12 studies found that women with breast cancer who had breast implants are diagnosed with later-stage cancers than women with breast cancer who did not have implants. This is likely due to delays in breast cancer detection because of implants. 26

A delay in diagnosis could result in the woman needing more radical surgery or the delay could be fatal.  A 2013 Canadian meta-analysis of five studies found that if women who had breast augmentation later developed breast cancer, they were more likely to die from it than women diagnosed with breast cancer who did not have breast augmentation. This increased risk of breast cancer-specific death is likely to be due to the greater inaccuracy of mammography for women with implants.25

An NCI study found that women who had breast implants for at least 12 years were more likely to die from brain tumors, lung cancer, other respiratory diseases, and suicide compared with other plastic surgery patients.27 Augmentation patients were not more likely to smoke than other plastic surgery patients, so the difference in respiratory diseases did not appear to be due to smoking. However, more research is needed to better control for relevant health habits. Three Scandinavian studies have reported that women who had breast implants for augmentation were three times more likely to commit suicide compared to women in the general population.28,29, 30

What Are Other Concerns?

Breastfeeding. According to the Institute of Medicine (IOM), women with any kind of breast surgery, including breast implant surgery, are at least three times as likely to have an inadequate milk supply for breastfeeding.12 Concerns about the safety of breast milk have also been raised, but there has not been enough research to resolve this issue.  A study of a small number of women with silicone gel breast implants found that the offspring born and breastfed after the mother had breast implants had higher levels of a toxic form of platinum in their blood than offspring born before the same women had breast implants.30

Problems with Memory and Concentration. Women with implants have raised concerns about memory loss, difficulties with concentration, and other cognitive problems. FDA’s analysis of studies by implant companies found a significant increase in neurological symptoms, such as poor concentration, for women who had silicone implants for two years compared to their symptoms just prior to getting implants. These differences were maintained even when the women’s ages were statistically controlled.32 Some experts believe these symptoms could be related to the small amounts of platinum that are used to make silicone gel breast implants, since potentially toxic levels of platinum have been found in the blood and urine of women with implants.33

Unfortunately, there is no well-designed published epidemiological research to determine whether there is an association between these complaints and breast implants.

Financial Costs. Breast implant surgery is not a one-time cost. On average, implants last 7-12 years, and each replacement adds to the cost. Even if the implant itself is replaced for free, or if the surgeon offers his or her services for free, the cost of the medical facility, anesthesiology, and other expenses can still cost many thousands of dollars for each surgery.  These expenses are affordable for some women, but not for others, especially if the implant breaks after just a few months or years, or after a woman is divorced or loses her job.

When the FDA approved silicone gel breast implants in November 2006, it stated that women with these implants should have a breast MRI three years after getting silicone implants and every two years after that. 33 However, because of the expense and the reluctance of plastic surgeons to encourage MRIs for silent ruptures, very few women followed the FDA’s advice.  As of October 2020, FDA now recommends an MRI 5-6 years after the initial surgery and every 2-3 years after that. The purpose of the MRIs is to determine if the silicone gel breast implants are ruptured or leaking, because there are often no symptoms.33 Breast MRIs usually cost at least $2,000, and at some facilities they cost more than $5,000. It is important to remove silicone implants if they are ruptured, to avoid the silicone leaking into the breast or lymph nodes. That is an additional expense of at least $5,000, and can be $10,000 or more.

Saline implants do not require MRIs to check for leakage, and do not usually cost more than $5,000 to remove. The cost of MRIs and the additional cost of removing leaking silicone makes silicone implants substantially more expensive than saline.

What about health insurance? Typically, cosmetic surgery is not covered by health insurance, and problems resulting from cosmetic surgery are also not covered.9 Health insurance will not pay for MRIs to check for silicone leakage for augmentation patients. In some states, major health insurance providers do not insure women with breast implants.9 Some insurers will sell health insurance to women with implants, but charge them more, and some insurers will not cover certain kinds of illnesses – or any problems in the breast area – for women with breast implants. Obviously, this can be a terrible problem for women who are diagnosed with breast cancer or any other illnesses that are excluded, whether or not those diseases are related to the implants.

What If I Need to Get My Implants Removed?

Women who have implants sometimes decide to have them removed because of complications, disappointment with how they look or feel, or concern about the long-term health risks. Some surgeons discourage patients from removing their implants. This may be because they don’t share the patient’s concerns, or because they know that some patients will be very unhappy with their appearance after the implant is removed. (See photo #3 here) Women with ruptured silicone implants often lose breast tissue as part of the removal surgery. If silicone has leaked into the breast tissue, the resulting removal surgery may be similar to a mastectomy. (See second photo here).

As noted in the earlier section about safety, many women report symptoms of “breast implant illness.”  After being tested to try to find a cause or treatment, an increasing number of these women are choosing to have their implants removed.  Fortunately, if the entire scar capsule and breast implants are carefully removed, most of these women find that their symptoms disappear or are greatly reduced.21,22

The plastic surgeon who performed the original surgery is not necessarily the best choice for removing the implant. Removal can be much more complicated and expensive than the original surgery, especially after a silicone gel implant has broken. Some plastic surgeons are very experienced at removal and are especially skilled at getting the best possible cosmetic result. Most surgeons who specialize in removal recommend removing the implants “en bloc,” which means that the implant and the intact scar tissue capsule surrounding it are all removed together. This helps remove any silicone that may have leaked from a broken gel implant, and also helps remove silicone or other chemicals that may have “bled” from the silicone outer envelope.

Are There Newer, Safer Implants?

As part of new research studies, plastic surgeons sometimes offer “gummy bear” breast implants, named after gummy bear candies because the implants are a thicker, more cohesive silicone gel. Since the shell and gel in these newer models are thicker than most other silicone gel implants, it is possible that they might be less likely to break or leak into the body.

Despite only 3 years of data provided by Silimed (Sientra) on relatively small numbers of patients, the FDA approved their “gummy bear” implants in 2012.  New implants often have risks that are not immediately obvious, and even after only 5 years of data were available, it was obvious that these gummy bear implants had similar types of complications  to other silicone implants. Only when the cohesive gel implants are in women for more than 10 years will we know whether and how the implant deteriorates or changes when it is in the human body.

Why long-term safety studies matter. In addition to silicone and saline implants, three other kinds of implants were developed and used primarily outside the United States: Trilucent implants (with soybean oil filler), and Novagold and PIP hydrogel implants, which were filled with a plastic gel.  They provide examples of why long-term safety studies are so important.

Although these implants were enthusiastically promoted by plastic surgeons and the media as a “natural” and safer alternative to silicone or saline implants, clinical trials were apparently never conducted on humans with these implants. By 2000, serious safety concerns resulted in the removal of all three from the market.34,35,36 The fact that they had been praised by doctors and patients when they were initially introduced serves as a reminder that the long-term risks of implants are not always obvious during the first few years of use. That is why studies of the risks of long-term use – which are still lacking for silicone implants – are essential to establish the safety of all kinds of implants.

Conclusions

Research clearly shows that implants are associated with significant health, cosmetic, and economic risks within the first few years and these risks increase over time. Unfortunately, long-term risks remain unknown because of a lack of well-designed and carefully conducted scientific studies. When they approved silicone gel breast implants in 2006, the FDA required two implant manufacturers, Allergan and Mentor, to each conduct 10-year studies of at least 40,000 women  to determine why implants break, how long they can be expected to last, and what the longer-term health consequences of broken and leaking breast implants might be. Unfortunately, however, those studies were never completed and the FDA did not require the companies to substitute similarly well designed studies.

Related Articles

Study on Silicone Breast Implants and Unexplained Symptoms

Breast Implants and Cancer of the Immune System (ALCL): A History of Who Knew What When

Why are celebrities removing their breast implants?

For more information about breast implants, see www.breastimplantinfo.org.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References:

  1. 2020 Complete Plastic Surgery Statistics Report, American Society of Plastic Surgeons.
  2. ASAPS Percent of Change in Select Procedures: 1997-2004.American Society for Aesthetic Plastic Surgery (ASAPS), 2005. www.surgery.org. ASAPS estimates approximately 70,000 more augmentation surgeries in 2004 than does ASPS.
  3. FDA transcript of the Advisory Panel Meeting on Mentor Saline Breast Implants, testimony of Dr. Sahar Dawisha, pages 431-7, 441, at http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3596t1.rtf; FDA transcript of the Advisory Panel Meeting on McGhan Saline Breast Implants, testimony of Dr. Sahar Dawisha, pages 129-148, at http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3596t2.rtf. Local complications are even higher, and tend to be more serious, for women with silicone gel breast implants. See Inamed Corporation’s McGhan, Silicone-Filled Breast Implants, October 14-15, 2003, slides 39-42 and 49-51, at http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1.ppt
  4. FDA Summary Panel Memorandum of Inamed PMA, pages 21-22, at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed Panel Memo.pdf, Zuckerman D, Santoro E, Hudak N. Silicone Breast Implants: Illnesses and Complications, The Latest Research from Inamed’s Core Study at www.breastimplantinfo.org/what_know/oct03_summary.html.
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  16. Aziz NM, Vasey FB, Leaverton PE, et al. Comparison of clinical status among women retaining or removing gel breast implants. Presented at the American College of Epidemiology, 1998.
  17. O’Hanlon TP. Restricted and Shared Patterns of TCR b-chain Gene Expression in Silicone Breast Implant Capsules and Remote Sites of Tissue Inflammation. J Autoimmunity. 2000; 14: 283-293.
  18. Breiting VB, Holmich, LR, Brandt B, Long-term health status of Danish women with silicone breast implants. Plastic and Reconstructive Surgery. 2004; 114: 217-226.
  19. Balk, Ethan M, et al. “Systematic Review of Selected Adverse Outcomes and Symptoms in Women with Silicone Gel Breast Implants.” Tufts Center for Clinical Evidence Synthesis, Tufts Medical Center. https://www.brown.edu/academics/public-health/research/evidence-synthesis-in-health/sites/brown.edu.academics.public-health.research.evidence-based-medicine/files/uploads/Silicone%20breast%20implants%20Report.pdf
  20. MD Anderson. “Largest-Ever Study Shows Silicone Breast Implants Associated with Rare Diseases.” MD Anderson Cancer Center, University of Texas, www.mdanderson.org/newsroom/2018/09/largest-ever-study-shows-silicone-breast-implants-associated-with-rare-diseases.html.
  21. Wee, Corinne E et al. Understanding Breast Implant Illness, Before and After Explantation: A Patient-Reported Outcomes Study. Annals of plastic surgery vol. 85,S1 Suppl 1 (2020): S82-S86.
  22. Wee, Corinne E. MD*; Younis, Joseph BS*; Boas, Samuel BS*;et al. The objective effect of breast implant removal and capsulectomy on pulmonary function. Plastic and Reconstructive Surgery – Global Open: June 2021;9(6): e3636. Retrieved from https://journals.lww.com/prsgo/fulltext/2021/06000/the_objective_effect_of_breast_implant_removal_and.57.aspx
  23. Nyren O, Yin L, Josefsson S, et al. Risk of Connective Tissue Disease and Related Disorders Among Women with Breast Implants: A Nation-Wide Retrospective Cohort Study in Sweden. British Medical Journal. 1998; 316: 417-422.
  24. Miglioretti DL, Rutter CM, Geller BM, et al. Effects of breast augmentation on the accuracy of mammography and cancer characteristics. JAMA, 2004; 291: 442-50.
  25. Brown SL, Todd JF, and Luu HD, Breast Implant Adverse Events during mammography: Reports to he Food and Drug Administration, Journal of Women’s Health 2004, 13: 371-378.
  26. Lavigne E., Holowaty EJ, Pan SY, Villeneuve PJ, Johnson KC, Fergusson DA, Morrison H, & Brisson J. Breast cancer detection and survival among women with cosmetic breast implants: Systematic review and meta-analysis of observational studies. British Medical Journal 2013: 346: f2339. doi: 10.1136/bmj.f2399.
  27. Brinton LA, Lubin, JH, Murray MC, et al. Mortality among augmentation mammoplasty patients: An update. Epidemiology. 2006; 17: 162-9.
  28. Koot VCM, Peeters PHM, Granath F, et al. Total and cause specific mortality among Swedish women with cosmetic breast implants: prospective study. British Medical Journal. 2003; 326: 527-528.
  29. Pukkala E, Kulmala I, Sirpa-Liis H, et al. Causes of death among Finnish women with cosmetic breast implants. Annals of Plastic Surgery, 2003; 51: 339-42.], [end Jacobsen PH, Holmich LR, McLaughlin JK. “Mortality and suicide among Danish women with cosmetic breast implants.” Archives of Internal Medicine. 2004; 164: 2450. 
  30. Jacobsen PH, Holmich LR, McLaughlin JK. “Mortality and suicide among Danish women with cosmetic breast implants.” Archives of Internal Medicine. 2004; 164: 2450
  31. Maharaj SVM, & Lykissa ED. Total platinum in urine of women exposed to silicone breast implants and in their children conceived after implantation by ICP-MS. Abstracts of Papers, 230th National Meeting of the American Chemical Society, Washington, DC, United States, Aug. 28-Sept. 1, 2005. American Chemical Society, Washington, DC, 2005; ANYL 510.
  32. Inamed Corporation’s McGhan, Silicone-Filled Breast Implants, October 14-15, 2003, slides #45 and #55, at http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1.ppt.
  33. Saline, Silicone Gel, and Alternative Breast Implants: Guidance for Industry and
    Food and Drug Administration Staff, https://www.fda.gov/media/71081/download
     (For other identical MRI warnings for Mentor and reconstruction patients, see http://www.fda.gov/cdrh/breastimplants/labeling.htm).
  34. UK Department of Health, Medicines and Healthcare Products Regulatory Agency. “Device Alert – Breast Implants: NovaGold.” UK: Medical Devices Agency. www.medical-devices.gov.uk/.
  35. Laurance J, “Agonizing wait for 5,000 women told that their breast implants might leak and cause cancer.” The Independent, 7 June 2000. www.independent.co.uk/story.jsp?story=5864.
  36. “Statement on the Safety of Trilucent Breast Implants.” UK: Medical Devices Agency. www.medical-devices.gov.uk/.

Dr. Diana Zuckerman’s Testimony on Moderna’s COVID Vaccine Before the FDA Advisory Committee

December 17, 2020.


I’m Dr. Diana Zuckerman, president of the National Center for Health Research.  Thank you for the opportunity to speak today.

Our center scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. My expertise is based on post-doc training in epidemiology and as a previous faculty member and researcher at Vassar, Yale, and Harvard, and a fellow in bioethics at University of Pennsylvania.  I’ve also worked at HHS, the U.S. Congress and the White House.

Today I will focus on 3 major concerns:

#1:  The 2 month median follow-up is too short, so Moderna’s proposal to immediately unblind and offer to vaccinate the entire placebo group should be rejected.

#2:  Moderna made a good effort to include a diverse group of participants, but only 4 COVID cases were in Black patients, and there were even fewer in other racial groups.  We can’t assume that the vaccine was highly effective in demographic groups with so few cases because just 1 Covid case in the vaccinated group would have greatly reduced the efficacy rate.

The data on cases for participants with co-morbidities was slightly more substantial, with 24 placebo cases and only 1 vaccinated case

#3  I’m glad to see that unlike Pfizer, Moderna provided info on the total number of  participants who reported 1 or more adverse events.  That’s important.  Unfortunately, the total of severe systemic adverse events after the 2nd dose was over 17% for vaccinated group compared to 2% for the placebo group.

There are also too few severe cases to draw conclusions:

There were 30 severe cases after the 2nd dose, and none were in the vaccine group.  This is a strong finding.  However, only 9 of the severe cases required hospitalization; 12 involved the questionable criteria of at least slightly low blood oxygen saturation.

Long-term care patients were not included in the study.  About 1300 people ages 75 and older were in the study, almost half of them vaccinated, but only 3 were cases (all of them placebo).  Only 15 cases were in patients over 65.

We want to save their lives, but with no data it’s not possible to provide useful informed consent to nursing home patients.  That puts a tremendous burden on those patients and their family members to decide whether or not to be vaccinated.

We need longer-term data to fully understand the benefits and risks for different types of patients.  The vaccine is clearly effective, but does that last 2 months, 4 months, or a year?  We need to know that, and that’s why it is essential that the blinded randomized controlled trial is continued.

In conclusion, EUA is not approval, and it should have more restrictions than approval would have.  The EUA should be targeted to priority populations, because if the EUA applies to all adults, celebrities and others who are well-connected will cut in line.  We’ve already seen that this week.

Other people could apply for the vaccine under FDA’s Expanded Access program.

We need at least 1 year of blinded, randomized, controlled data.  We agree with Dr. Goodman’s proposal that FDA should delay access to vaccines by members of the placebo group unless they are in priority populations.  Blinded crossover has limitations because it can’t control changes in the community spread of the virus, but it is better than not continuing a blinded controlled study, if continuing the current study is not possible.

FDA Panel Reviewing Pfizer Vaccine Leaves Out Some Experts Who Raised Concerns

David Hilzenrath, Project on Government Oversight: December 9, 2020.


When an FDA advisory committee meets tomorrow to review Pfizer’s coronavirus vaccine, the lineup of committee members will look different from the group that met in October to begin the committee’s discussion of coronavirus vaccines.

Four people who participated in the earlier meeting as temporary committee members, including experts who raised questions and expressed concerns about the testing process, do not appear on the “draft roster” of panelists the FDA has posted for tomorrow’s meeting.

Meanwhile, there will be new faces. The FDA has added 10 temporary committee members who did not participate in the earlier meeting.

The changes in the lineup raise concerns, Diana Zuckerman, president of the National Center for Health Research, said in answer to questions from the Project On Government Oversight (POGO).

Zuckerman said experts might have been excluded to avoid tough questions about Pfizer’s data.

“It is not unusual for temporary members of FDA Advisory Committees to change, but seems surprising since the issues they are considering at the Oct meeting and tomorrow are so similar,” Zuckerman said by email.

Zuckerman’s organization analyzes the safety and effectiveness of pharmaceuticals and other medical products.

POGO asked the FDA whether the disappearance of some people from the advisory committee lineup had anything to do with any questions, concerns, or opinions they have expressed. In response, an FDA spokesperson did not directly answer.

The FDA routinely supplements advisory committees with temporary voting members, including “scientists or medical personnel whose expertise may not be represented by the fixed voting membership,” the FDA spokesperson said by email. “Many times, committees need to invite experts who are unrelated to the knowledge and expertise spelled out in the committee charter if a medical product or topic for discussion calls for a specific need for a particular expert,” the spokesperson added.

That does not seem to explain why the FDA would drop temporary voting members it selected to participate in the October meeting. At that meeting, without evaluating any particular vaccine, the committee advised the FDA on how in general it should approach experimental coronavirus vaccines.

Dr. Luigi Notarangelo, an expert on clinical immunology at the National Institute of Allergy and Infectious Diseases, was not invited to participate in the December 10 FDA advisory committee meeting on Pfizer’s coronavirus vaccine. He served as a temporary committee member when the panel met in October and minced no words then as he expressed general concerns about the testing of coronavirus vaccines.

[….]

POGO recapped his commentary at the October meeting in a November 2 story, “FDA Whitewashes Warnings About Coronavirus Vaccine Trials.”

As POGO reported:

Dr. Luigi Notarangelo, a committee member who is a chief researcher at the National Institutes of Health, minced no words as he articulated several of the critiques.

Notarangelo said measures of vaccine effectiveness included in an FDA document the committee was asked to review have two problems.
“First of all, they really are biased—skewed towards mild disease,” he said. “Mild disease may not mean very much.”
“The other problem with those efficacy measures is that most of them are really subjective,” he said. “And I think that’s a major concern. I mean, we’re relying basically upon reporting from the subjects without any objective validation of what they’re reporting.”

At the time, Notarangelo was not commenting specifically on Pfizer’s data.

Another person who served as a temporary member on October 22 but does not appear on the roster for tomorrow is Kathryn Holmes, a professor emerita in the Department of Immunology & Microbiology at the University of Colorado School of Medicine.

“One of the things I have not heard much about during this conversation is infection,” Holmes said at the October meeting. “I’d like to see how we could actually be measuring infection rather than just mild disease. … We should be looking to see what can prevent infection because that is the rubric which would prevent spread through the community most effectively and that is what would protect our elderly as well.”

Holmes could not be reached for comment for this story.

Another person who participated in the October meeting but is not slated to participate tomorrow is Dr. Michael Nelson, president of the American Board of Allergy and Immunology and a physician at Walter Reed Army National Military Medical Center.

At the October meeting, Nelson said “more real-time data might be needed.”

Nelson also noted that, when the acting chair of the committee summarized members’ comments, he omitted “a lot of concern” about an aspect of how vaccine effectiveness was being measured—whether it was focused inordinately on preventing milder cases.

Read the full article here

What People With Cancer Need to Know about Coronavirus (COVID-19)

Diana Zuckerman, Ph.D., Cancer Prevention and Treatment Fund: updated February 10, 2021.

The coronavirus can infect anyone, young or old, healthy or frail.  But, people diagnosed with cancer during the last year are at higher risk of dying from COVID-19 if they are infected. Here’s what you need to know.

People who are over 60 or who have cancer and other serious health conditions, and their loved ones, need to be especially careful to avoid getting infected.  A study published in December 2020 of more than 2 million cancer patients, found that people diagnosed with cancer during the previous year are much more likely to die of COVID compared to other COVID patients.  All cancer patients were at higher risk, but the ones in most danger had been diagnosed with leukemia, non-Hodgkin’s lymphoma, or lung cancer. The CDC has also updated their list of other health problems that put people at greatest risk, and they include many common health conditions: Anyone who is obese (BMI of 30 or higher) or has a serious heart condition, Type 2 diabetes, a weakened immune system (from cancer or an organ transplant), chronic kidney disease, COPD, or sickle cell disease is especially at risk if they are exposed to the coronavirus.  Smoking also increases the risk of being seriously harmed by the virus, as do many other medical conditions, including high blood pressure, pregnancy, HIV, and liver disease.

If you had scheduled medical appointments, surgery, screening, or other procedures in the past year that were considered not urgent or not immediately life-threatening, those were probably postponed. This was for everyone’s protection.  Many hospital staff, including doctors, nurses, receptionists, and cleaning staff, have been vaccinated against COVID but their facilities may be limiting procedures that are not essential because the doctors are vaccinating others or are treating COVID patients. You don’t want to be exposed to the coronavirus when you go in for surgery or testing procedures for other medical conditions.  And, you don’t want your medical center to be less able to fight the coronavirus at a time when it is spreading throughout your community.

Will the COVID vaccines make it safer to have medical procedures or doctor’s appointments? To visit friends and family members?

Many healthcare workers have been vaccinated, but some nurses and aides have refused the vaccine so far.  You should ask about that when you make an appointment. Pregnant healthcare workers and those with serious allergies may choose not to be vaccinated. Pregnant healthcare workers and those with serious allergies may choose not to be vaccinated.  More important, the vaccines do not prevent infection, even though they usually prevent people from getting obviously sick.  If your healthcare worker is vaccinated, he or she could have asymptomatic COVID without knowing it, and could possibly infect others.  For that reason, healthcare workers and patients need to continue to wear masks and keep their distance.

The coronavirus is still spreading in all 50 states, in urban, suburban, and rural areas, so it is important to listen to health experts who tell you to stay home, limit contact with others, wear a mask, and keep a distance of 6 feet away when you or your family members or caregivers go grocery shopping or other essential activities. It will be months before most people are vaccinated.  Unfortunately, some governors, mayors, and state legislators have reopened businesses for political reasons, even in states where the virus is spiking.  Even if you are staying at home as much as possible, the fact that others in your community are going to bars, parties, restaurants, stores, and hair salons will put you at greater risk when you make essential visits to the supermarket, to work, to the doctor, or spend time outdoors, because you may come into contact with people who are infected because they aren’t being as careful as you are.

What is coronavirus?

Coronaviruses are a large group of viruses that can cause respiratory illness. The new (novel) coronavirus is called SARS-CoV-2 and the illness it causes is called coronavirus disease 2019, which is why it’s abbreviated as COVID-19.

How does COVID-19 spread between people?

The virus usually spreads through close contact with other people, especially through invisible or very tiny droplets when a person coughs, sneezes, sings, exercises – or even when they breathe or talk normally. These droplets can travel through the air and can be inhaled or get into the noses, mouths, or eyes of people nearby.

The virus is thought to be most contagious in the days just before and just after a person develops symptoms, but it is possible to catch the virus from infected people who have no symptoms at all.  Experts still don’t know how contagious the virus is when a person has it but never develops symptoms.  This is crucial information that scientists are trying to find out, especially since experts believe that many young children never develop symptoms, while other children get very sick and some have died from the coronavirus.

What about children?  Unlike the flu, which is riskiest for the youngest children and oldest adults, infants and young children are much less likely to get sick from the coronavirus than adults.  Preliminary studies suggest that children over 10 are as contagious as adults, but that younger children are much less infectious. For example, there are few known examples of the virus spreading in daycare centers that follow coronavirus safety standards. Nevertheless, almost half a million children have been diagnosed with the virus in the U.S. (almost 10% of all cases) and 70,000 children were newly diagnosed in late August, which was 17% more than the weekly number of new cases two weeks earlier.  Fortunately, few children become so sick that they are hospitalized (estimates range from less than 1% to 8.5%), and less than half of 1% of children diagnosed with coronavirus in the U.S. have died.

The tiny droplets from coughing, sneezing, singing, talking, or breathing (as well as fecal matter containing the virus) can result in the virus on surfaces where it can survive for hours or even days. When you touch these surfaces and then touch your face, you can be exposed to the virus. However, there are no documented cases of anyone catching COVID from a surface.  Nevertheless, it’s important to wash your hands regularly.  If you’re concerned about exposure at home, you can wipe down surfaces in your bathroom, kitchen, and other rooms with bleach or rubbing alcohol to help prevent exposure.

What about food or food packaging?  The risk of catching the virus from packaging is extremely low, but it’s a good idea to wash your hands for at least 20 seconds after handling mail, takeout containers, and packaging from groceries. You don’t need to disinfect food packages using a cleaning product that kills viruses, and NEVER use bleach or disinfectants on fruit, vegetables, or any other food.

What about the vaccines?

If you are eligible to be vaccinated with either the Pfizer or Moderna vaccine, that is the best protection available for most people.  Keep in mind, however, that the vaccines were not studied on nursing home patients and not studied on many people with COVID who were ages 65 or older, so it might be less effective for older people.  (Flu vaccines are often less effective for older people, because their immune systems are weaker).  The vaccines were found to be as safe for adults of all ages and races. The vaccines were  studied on few people under 18, pregnant women, people with compromised immune systems, or those with serious allergies, so it will be a while before we have information about safety or effectiveness data for them.

Both of the vaccines have frequent side effects such as fatigue and chills, especially after the second dose.  These are not considered dangerous, but it is important that anyone getting vaccinated is told about those risks, since they could be frightening to patients who don’t understand that those symptoms are not thought to be reason for concern.

What are the symptoms of COVID-19?

Symptoms tend to start between 2 and 14 days after coming into contact with the virus.  Although some people have compared the symptoms to a cold or flu, not everyone with COVID-19 has those types of symptoms.  In fact, some people (especially children, teens, and younger adults) have very mild symptoms or none at all, which is why getting tested is so important before you spend time with others. The CDC says that people with these symptoms or combination of symptoms may have COVID-19:

  • Cough
  • Shortness of breath or difficulty breathing

Or at least two of these symptoms:

  • Fever
  • Repeated shaking with chills
  • Muscle pain
  • Headache
  • Sore throat
  • New loss of taste or smell
  • Congestion or runny nose
  • Nausea or vomiting
  • Diarrhea

Those are the most common symptoms.  However, children or adults can have other symptoms as well, including heart problems and “covid toes” that look like a minor case of frostbite.

Most people who are infected with this coronavirus have mild symptoms and can recover at home in about 2 weeks. However, symptoms can become severe.  These are the ones that require immediate medical attention:

  • difficulty breathing or shortness of breath
  • persistent chest pain or pressure
  • confusion or inability to awaken
  • blueish color in the lips or face

As described above, people who are older than 60 or with other medical conditions are more likely to develop severe illness and complications from COVID-19. The most serious complications include pneumonia, stroke, blood clots, organ failure, and death.

How else can I protect myself and others?

If you are not yet eligible to be vaccinated, the best way to protect yourself is to avoid being exposed to the virus. There are no proven cures, so don’t be fooled by claims, regardless of the source.  Two types of medications have been found to help people who are seriously ill, but are not a cure.  Remdesivir has been found to help very ill patients by reducing the number of days of hospitalization in one study, but was not effective in a WHO study published in October.  It has not been proven to save lives. Two inexpensive steroids, dexamethasone and hydrocortisone, have been found to reduce the chances of dying among COVID-19 patients on ventilators or those requiring oxygen, but not other patients. Regeneron, the experimental antibody drug that President Trump took when he was diagnosed, is not generally available but has been used with good results by some friends of the President.  However, it was found to have a potential safety concern and as of October 30 is no longer being administered experimentally to hospitalized patients receiving mechanical ventilation of intense oxygen.  It is still being studied on less seriously ill COVID-19 patients.

Experts now agree that hydroxychloroquine with or without azithromycin is not a good treatment for COVID-19 because it has been found to increase heart problems and has not been shown to prevent or treat COVID-19.  Another possible treatment is blood plasma from people who recovered from COVID-19.  Research has shown these transfusions are usually safe, but there is no clear evidence that they are beneficial.

Research is continuing to find out which of these treatments are safe and effective and for which patients.

“Social distancing” or “physical distancing” refers to staying away from other people because it is impossible to know who has the virus.  The safest people in your life are the ones you are living with who are not exposed to others who might have the virus (in other words, they are not going to work or spending time close to other people). Staying at home and not seeing your friends and loved ones is not fun, but it is essential for your own safety and for everyone else’s.  If everyone does that now, the spread of this virus will be reduced sooner, and some of these restrictions will no longer be necessary in a few weeks.

Spending time with friends, family, or people at work

In general, the more people you interact with, the more closely you interact with them, and the longer that interaction, the greater your chances of becoming infected or infecting othersThat’s why there have been so many cases after Thanksgiving, and why hospitals are full all over the country. So, think about:

  • How many people will you interact with?  (The fewer the better)
  • Can you keep 6 feet of space between you and others?
  • Will you be outdoors or indoors? (Outdoors is somewhat safer. It can be heated but not if it has walls all around and a ceiling.)
  • What’s the length of time that you will be interacting with people? (Shorter is better)

Research conclusively shows that face masks that cover your mouth and nose help to prevent the spread of the coronavirus.  Some masks are more effective than others:  stretchy “gators” may actually do more harm than good, and bandanas and scarves are too loose to be very helpful.  The paper surgical masks worn in hospitals are effective and so are cloth masks you can make for yourself or buy, if they are made of cotton and at least two layers thick. Masks are important to prevent people from spreading the virus and also to help helps prevent infection or serious symptoms for the person wearing the masks. Experts suggest wearing two masks at the same time for extra protection.

Bottom line: Since most of us haven’t been vaccinated and can’t get coronavirus tests every day, it’s especially important to wear masks whenever you are out in public or with people you don’t live with.  But you should NOT be out in public or with people you don’t live with except when it’s essential.  Depending on your age, health, and who you spend time with, it may not be safe for you to go to all the places that are open.  Especially avoid indoor areas where you are likely to be close to others for more than a very short period of time (15 minutes) or whose workers are close to many other people, such as a tattoo parlor, hair or nail salon, restaurant, concert, party or movie theater.  If you must go to a store, try to go to one that makes appointments with customers or limits the number of customers, and spend less than one hour indoors to reduce exposure to any coronavirus that is in the air.

In summary:

  • Stay at home or go outside in your yard or neighborhood where you can keep at least 6 feet away from others
  • Avoid public spaces where there are other people, especially indoors
  • Avoid public transportation when possible and unnecessary travel
  • Avoid all social gatherings that are indoors or where people are close together
  • Work from home if possible
  • Stay at least 6 feet away from people when out in public (indoors or outdoors). Further away is even better, especially if people are singing or talking, or if there isn’t good air filtration.
  • Avoid physical contact in social situations, such as shaking hands, hugging or kissing

AND

  • Wash your hands using soap and water for at least 20 seconds, especially after being out in public
  • Use alcohol-based hand sanitizer when soap and water aren’t available (or wash your hands as soon as you get home)
  • Avoid touching your face when your hands aren’t clean or you are out in public
  • Avoid contact with people you don’t know very well
  • Put the toilet seat down before flushing in a shared or public bathroom
  • A lower priority would be to clean and disinfect surfaces, and only those in your home or workplace that could expose you frequently to the virus, including doorknobs, light switches, faucet handles, and phones. An antibacterial cleaning agent won’t kill a virus, so try to find one that is effective for killing viruses.

If you have a weakened immune system or other serious health problems, here are extra steps to protect yourself:

  • Make a plan with your doctor to monitor for symptoms
  • Avoid friends and family except those you live with or depend on for essentials.  Otherwise, rely on your phone or computer to maintain contact.
  • Have a plan with your loved ones or caregiver if you or they get sick
  • Have the medications you rely on and order any you need in advance (to be delivered, if possible)
  • Ask a friend or family member to shop for groceries for you
  • Wash your hands (20 seconds with soap and water) even more often if you are exposed to others

What should I do if I develop symptoms?

If you develop more than one of the symptoms listed above, call your doctor.  If you have severe symptoms, such as difficulty breathing, persistent chest pain or pressure, confusion or inability to awaken, or blueish color in the lips or face, you need to call 911. Tell the 911 operator that you think you have COVID-19 so the responders can take the necessary precautions to protect themselves.

People who experience mild symptoms can usually stay home and will recover in about 2 weeks. Do not just show up at the doctor’s office with symptoms:  Call them first so you have tell them about your symptoms and any other health problems so that they can help decide what to do.  If you do become sick, you can take the following steps to protect others:

  • Stay home, unless you need essential medical care
  • Wear a facemask when you are near others.  (People caring for you should also wear a facemask).
  • Stay away from others in your home as much as possible
  • Cover your mouth and nose when you cough or sneeze, properly dispose of tissues, and wash your hands
  • Monitor your symptoms and temperature

If you were not tested for COVID-19, you should follow those steps until at least one or two weeks have passed since you first noticed symptoms or your fever or other symptoms go  away for 3 full days without medicine.  If you have been diagnosed with COVID-19 based on test results, you should follow those same steps until you have 2 negative test results taken 24-hours apart, and your symptoms improve.

What if my other scheduled medical treatment is delayed?

When a person is diagnosed with a serious disease, they are likely to want treatment as soon as possible. If you don’t have COVID-19, you don’t want to be exposed to it during surgery, testing, or follow-up appointments. Treatment or testing may seem more urgent than it really is, but it is definitely more important than going to a restaurant, store, or party.  Some medical centers are overwhelmed with Covid-19 patients, and others are not. Talk to your doctor about what is the best strategy to get the treatment you need when it is safe to do so.

Questions?

We are here to help by answering your questions.  We do not provide medical care.  If you have questions contact info@center4research.org and we’ll get back to you as soon as possible.