Category Archives: Policy

NCHR’s Comments on the Safer Technologies Program (STeP) for Medical Devices

National Center for Health Research, November 18, 2019


National Center for Health Research’s Public Comments on 
Safer Technologies Program for Medical Devices; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability
[FDA-2019-D-4048]

Thank you for the opportunity to express our views on the proposed Safer Technologies Program (STeP) for medical devices.

The National Center for Health Research (NCHR) is a non-profit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. 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 appreciate FDA’s efforts to get medical devices with an improved safety profile to consumers and patients more quickly. However, the mission of the FDA is to protect patients and consumers from medical products that are not proven safe or not proven effective. FDA guidance must be very clear how this program would protect patients from unsafe or ineffective medical devices. The proposed guidance is so vaguely worded that it is not possible to have confidence that patients’ needs will be protected.

We agree that increased interactions with FDA throughout the development process and more timely interactions could 1) speed development and review, and 2) improve the quality of the data available for review by providing more consideration into needed data, study design, and early detection of concerns. Unfortunately, most medical devices are cleared through review pathways that require little or no clinical data to demonstrate safety or effectiveness, and while premarket approval applications (PMA) require clinical trial data, those studies are often small, poorly designed, and lacking in appropriate control groups. Thus, while the proposed Safer Technologies Program may get medical devices to patients sooner, the program will be harmful to patients unless it also strengthens the premarket requirements for scientific evidence of safety and effectiveness.

Textured breast implants, Essure, POP mesh, and metal-on-metal hip replacements are just a few of the many examples of devices that were implanted in tens of thousands of patients and consumers prior to being removed from the market due to serious, unexpected complications. It is disturbing that the proposed guidance includes no explicit instructions aimed at reducing the harm caused when patients unwittingly serve as guinea pigs for implants and other devices that were not adequately tested prior to going on the market. It is not fair to patients or their physicians to rely primarily on post-market studies and surveillance, because too many patients will be harmed before those studies are completed, and too many of those studies will never be completed. We therefore respectfully urge the FDA to revise the proposed guidance in ways that ensure that all medical devices undergo more rigorous testing prior to being approved or cleared.

For questions or more information, please contact the National Center for Health Research at info@center4research.org or at (202) 223-4000.

NCHR Testimony on Research Needed on Immunological Responses to Metal in Implants

Diana Zuckerman, PhD, National Center for Health Research, November 13, 2019


Thank you for the opportunity to speak at this Advisory Committee meeting today regarding immunological responses to metal in implants.

The National Center for Health Research is a nonprofit research center that focuses on the quality of medical products and procedures and does not accept funding from medical device companies or pharmaceutical companies. I’m here today to share my perspective as a scientist as well as a patient.  I am trained in epidemiology and served on the faculty at Vassar and Yale and as a researcher at Harvard.  I’ve also worked in the U.S.  Congress on FDA issues and as president of the National Center for Health Research I have  a great deal of experience with FDA regulatory issues.

In addition, I got a hip implant 10 years ago, and I’m glad to say my experience has been a very good one.  But at the time I was deciding on the surgery, neither the surgeons I interviewed nor the research literature provided the kind of information I needed to make an informed choice.  In fact, one surgeon recommended a metal-on-metal hip for me because I was relatively young and active.  Fortunately, I was already aware of metal debris issues so I did not make that choice.  But the lack of information then and now was very clear to me as a patient.  I was not able to obtain scientific data from the surgeons or online, including PubMed.

I want to say that this has been one of the most interesting and informative FDA meetings I’ve attended, and the speakers have provided a great deal of important information.

What Research is Needed?

I’m here to talk about the big picture.  We’ve heard this morning about a great deal of research findings and the need for more and better research.  I want to emphasize that we need much better pre-market studies, not just post-market studies.  Pre-market clinical trials are often lacking because of the 510(k) process, but even when premarket clinical trials are conducted, they are often inadequate to provide the information patients deserve.

We need clinical trials and other well-designed studies of large number of patients, and as one of the speakers said this morning, we need to compare information about patients who have good experiences with their implants with those who do poorly with their implants.  These studies need to include a patient population with sufficient diversity in terms of age, sex, race, BMI, activity levels, allergies, and metal sensitivity, to determine how safe and effective the products are for these subgroups.

We need clinical trials and big data analyses that follow patients for years in order to evaluate the effects of wear and changes in immune responses over time.

We heard this morning that patch testing is inadequate to identify which patients will have a negative reaction to an implant, and that other diagnostic testing also has limitations.

I also want to express our concern with the tendency to extrapolate results from an implant used in one part of the body to implants made of the same materials that are intended to be used in another part of the body.   We know from listening to patients that this can result in terrible problems.

We are also concerned about extrapolating results from an earlier version of an implant to a newer implant, when the newer implant differs in ways that could affect safety and effectiveness.  Those differences might be different metals, changes in size or shape, differences in manufacturing, or numerous other changes typically made in an effort to improve implanted devices.

We encourage the FDA to require that studies specifically look for adverse events that are related to immune reaction or wear.  These adverse events might be local or might be systemic, and some of these events would not necessarily be included in studies asking about all adverse events.

Perhaps most important, we need comparative effectiveness studies that compare clinical effectiveness and patient-centered outcomes.  I know that the FDA rarely requires comparative effectiveness studies, but those are the types of studies that are most likely to provide useful information for patients and their physicians.

If certain implants seem to be causing certain reactions with certain kinds of patients, wouldn’t it be very important to know how that compares to other alternatives of the same kind of implants? We can’t treat all hip implants that are polyethylene and metal as if they’re all the same.  We can’t treat all metal-on-metal implants as if they’re the same. We need to compare different models, different implants made in different ways with different materials by different companies and get the kind of real data that patients and physicians can use to make informed decisions. Until then, it won’t be possible to figure out to what extent negative responses and implant failures are due to patient vulnerabilities or sensitivities and how much is due to the difference between various devices.

For more information about this public meeting, read these articles here or here.

NCHR Letter to Mayor Cohn and Members of the Rye City Council Concerning the Health Risks of Artificial Turf and Playgrounds

National Center for Health Research, November 18, 2019


Download the letter here.

Dear Mayor Cohn and Members of the City Council:

Residents of Rye reached out to me to obtain my expertise in assessing the validity of the articles and letters provided by Stantec Design Services, regarding the health risks of installing artificial turf at what is now Nursery Field.   I am providing this information pro bono because our nonprofit research center is very concerned about the misleading information that has been presented to Rye officials regarding artificial turf.

The purpose of this letter is to focus on the research literature summarized and presented in Stantec’s review, including those in their Appendix.  It will not be focused on the logistical issues, but rather the health issues of importance to children using the field, and those who would be exposed to the chemicals in artificial turf because of its location near homes, wetlands, and a main tributary to Long Island Sound.

I will focus first on the claims that artificial turf does not cause cancer.  Dr. Archie Bleyer, quoted by Stantec, has impressive credentials, but his conclusions are based on his expertise regarding decades-old research while ignoring many of the most recent published studies.  Most important, as city officials, it is essential to distinguish between the lack of conclusive research linking artificial turf to cancer, and the often-made claim by the turf industry that artificial turf does not cause cancer.  The lack of conclusive proof of danger is not equal to proof of safety.  It is widely known that artificial turf contains chemicals that are probable and known carcinogens.   However, it takes years for cancer to develop after exposure to carcinogens.  For example, most smokers start smoking as teenagers but they don’t develop lung cancer for at least 3-4 decades. The reports of cancer clusters, such as the one among soccer players in Washington state, are the first hint that exposure to the chemicals contained in artificial turf increase the risk of cancer, but this too takes years to conclusively determine whether the cancer risk is higher due to the exposure.  That is one of the reasons why cancer clusters, such as the one reported in Washington State, can rarely determine causality.  It reminds me of cancer clusters among Vietnam veterans exposed to Agent Orange that were considered just a fluke until years later, when researchers concluded that Agent Orange caused certain types of cancer.  While we wait for this research, we cannot accurately conclude that there is no risk. Instead, we can only state that we do not know the level of risk.

Equally important, cancer is not the only health risk associated with the use of artificial turf.  The rubber pieces break down into very small pieces called particulate matter, which are kicked up into the air when the field is used where they can be inhaled.  The particulate matter can aggravate asthma, and can contain irritants and heavy metals.  The research cited by Stantec ignores that serious issue.

In addition, as the field gets hot, which can be 50-80 degrees hotter than the air or natural grass, the heat can cause heat stroke and even cause burns.  The highest temperature we have tested on a summer day in the 90’s was over 180 degrees.  In addition, heat from the fields makes it more likely that the chemicals are released into the air.  These can include polycyclic aromatic hydrocarbons (PAHs), and endocrine disruptors such as phthalates. These exposures can contribute to obesity, early puberty, ADHD, and eventually cancer.  Children are more vulnerable to these exposures than adults.

The Massachusetts HHS letter from 2015 and the letter from the State of Connecticut from 2015 both attempt to summarize information that focuses on cancer data but is broader than the cancer risk of artificial turf.  However, the studies quoted in the letter are small and so their generalizability to other fields is limited.  Importantly, it excluded several studies that raised concerns about the risks posed by artificial turf and pre-dates several more recent studies that have raised serious health concerns.

This year, testing in several communities found dangerous levels of lead in artificial turf as well as playgrounds made from synthetic rubber.  For example, testing of playgrounds and artificial turf fields in affluent and lower-income communities in Washington, D.C. resulted in more than 2 dozen that were closed due to health risks (see signs below).

Sign on artificial turf field stating that the field failed an "impact attenuation" or "hardness" test, which means that there is an increased risk of injury in the event of a fall.Sign - Warning: Do not eat infill mix in artificial turf as it may be harmful to your health

In the below left photo, children are playing on an artificial turf field near their school; tire crumb infill that had been hidden in the plastic grass came to the surface due to rain and wind.

Children playing in tire crumb infill from field

Used artificial turf with trash in the dumpster

The environmental implications of artificial turf are also important.  In the above right photo, you can see old turf has been dumped in a dumpster with trash. Much of the infill has already spread to the nearby playground, grass, and stream.

I will now focus on just a few of the studies that were not discussed in the letters submitted by Stantec, all of which demonstrate the very serious, evidence-based concerns about health risks, in chronological order:

Shalat 2011 (for the New Jersey Department of Environmental Protection) – They analyzed lead and other metals in particulate matter (dust) that is kicked up into the air by activity on the field, and thus, able to be inhaled, on 5 artificial turf fields.  The study found that there was more inhalable particulate matter in the air around a moving object (either a robot or a child soccer player) than a stationary collection system on the side of the field.  This suggests that studies using stationary collection systems underestimate exposures.  It also suggests that even low levels of activity on the field can cause inhalable particulate matter to get into the air where it can be harmful.  The study also found that the oldest field studied (8 years old) had more inhalable particulate matter than younger fields in this study (1–3 years old).  This is especially worrisome because the dust contains lead.  The authors state, “While it is not possible to draw broad conclusions from this limited sample of fields, the results suggest that there is a potential for inhalable lead to be present on turf fields that have significant amounts of lead present as detectable by surface wipes.  It also would appear likely from this sample that if the lead is present to any appreciable extent in the wipes it will likely be present in the breathing zone of players who are active on these fields, and that furthermore, these levels potentially exceed ambient EPA standards.”  Since no level of lead exposure is considered safe for children, “only a comprehensive mandated testing of fields can provide assurance that no health hazard on these fields exists from lead or other metals used in their construction and maintenance.”[1]

Llompart et al 2013 (Universidad de Santiago de Compostela) – This study examined samples from 9 playgrounds and 7 newly purchased rubber floor tiles that were made from recycled tire rubber in Spain.  It found all samples released hazardous chemicals into the air, where they can be inhaled, some of which were at high or very high levels. PAHs were found in all samples, including the carcinogenic B[a]P.  Other chemicals of concern include the phthalates DEP, DIBP, DBP, DEHP, and BHT.  The authors conclude, “The present study highlights the presence of a high number of harmful compounds, frequently at high or extremely high levels, in these recycled rubber materials.  Therefore, they should be carefully controlled, and their final use should be restricted or even prohibited in some cases.”[2]

Marsili et al 2014 (Siena University) – This study evaluated the recycled rubber infill (4 samples were not yet installed and 4 from fields that were 1-8 years old) and 1 new sample from virgin rubber in Italy. It found that levels of cadmium and zinc exceeded regulatory requirements for some or all samples, respectively. It also found very high levels of PAHs released into the air from some samples. After calculating a risk assessment for PAH inhalation from synthetic fields, the authors stated that “the quantity of toxic substances it releases when heated does not make it safe for public health.”[3]

Canepari et al 2016 (Sapienza University of Rome) – This study examined particulate matter and extractable chemicals from 1 sample of recycled tire rubber, 2 new and a single 7-year-old sample of natural rubber, and 1 sample of last-generation thermoplastic elastomer crumb (TPE).  The recycled tire rubber had a larger concentration of toxic elements, such as heavy metals.  TPE released the lowest amount of elements with high concentrations of only magnesium and calcium.  Natural rubber was more sensitive to aging and more easily broke down into small pieces that could be inhaled.  The authors concluded, “The use of natural rubber and of not-recycled thermoplastic materials, which are progressively replacing recycled tire scraps as synthetic turf fillers, does not seem to be adequately safe for human health, particularly when considering that children are the most exposed bracket of population.  Exposure risks arising from the use of these materials deserve to be further deepened.”[4]

Celeiro et al 2018 (Universidad de Santiago de Compostela) – This study evaluated the amount of chemicals released into the air from samples of recycled tire rubber infill from 15 soccer fields in Spain.  Analysis found high levels of PAHs, including the highly toxic B[a]P.  The levels of PAHs exceeded REACH Regulations for consumer products.  The study also found heavy metals such as cadmium, chromium and lead, as well as phthalates, adipates, vulcanizing agents and antioxidants could leach into runoff. “The environmental and health risks derived from the use of these surfaces have to be considered and some regulations should be adopted.”[5]

Benoit and Demars 2018 (Yale University) – This study analyzed 9 bags of recycled tire mulch from chain stores and 6 samples of recycled tire infill for athletic fields.  It focused on the chemicals which people using the fields would be expected to be exposed to, and found 92 chemical compounds.  Only about half of these compounds have been tested for effects on human health, of which 9 are carcinogens and 20 are irritants.  They concluded, “But what is known is that people routinely ingest, inhale, handle, and have abrasions which contact ground tire material.  That being so, it is prudent to assume that any chemicals in the tires or released by them can be transferred to exposed individuals.  This study shows that a large number of compounds, many of them carcinogenic or irritants, are released from shredded recycled tires through several potential routes.  Caution would argue against use of these materials where human exposure is likely, and this is especially true for playgrounds and athletic playing fields where young people may be affected.”[6]

Perkins et al 2019 (Yale University) – Based on previously published research, the researchers identified 306 chemicals found in crumb rubber. Fifty-two of these chemicals were classified as carcinogens by the U.S. EPA and/or the European ECHA. Then the researchers used the known characteristics of each chemical, such as the structure, to predict whether or not it was likely to be a carcinogen. Using this process, 197 were predicted to be carcinogens. They concluded, “Our study highlights a vacuum in our knowledge about the carcinogenic properties of many chemicals in crumb rubber infill.”  “The crumb rubber infill of artificial turf fields contains or emits chemicals that can affect human physiology.”[7]

The bottom line:  There is a growing body of evidence of the risks of the chemicals and lead in artificial turf and rubber surface playgrounds.  It would not be ethical to intentionally expose children to these play areas, and no independent researchers or government researchers have conducted long-term studies to determine if children with greater exposures are more likely to develop the health problems that are expected, such as obesity, asthma, cognitive damage, early puberty, and eventually cancer.

Please contact me with any questions at (202) 223-4000 or dz@center4research.org .

Sincerely,

Diana Zuckerman, Ph.D.
President

References

  1. Shalat SL. An Evaluation of Potential Exposures to Lead and Other Metals as the Result of Aerosolized Particulate Matter from Artificial Turf Playing Fields. 2011. New Jersey Department of Environmental Protection. http://www.nj.gov/dep/dsr/publications/artificial-turf-report.pdf
  2. Llompart M, Sanchez-Prado L, Pablo Lamas J, et al. Hazardous Organic Chemicals in Rubber Recycled Tire Playgrounds and Pavers. Chemosphere. 2013;90(2):423-431. https://doi.org/10.1016/j.chemosphere.2012.07.053
  3. Marsili L, Coppola D, Bianchi N, et al. Release of Polycyclic Aromatic Hydrocarbons and Heavy Metals from Rubber Crumb in Synthetic Turf Fields: Preliminary Hazard Assessment for Athletes. Journal of Environmental & Analytical Toxicology. 2014;5(2):265 http://dx.doi.org/10.4172/2161-0525.1000265
  4. Canepari S, Castellano P, Astolfi ML, et al. Release of Particles, Organic Compounds, and Metals from Crumb Rubber Used in Synthetic Turf under Chemical and Physical Stress. Environmental Science and Pollution Research International. 2018;25(2):1448-1459. https://doi.org/10.1007/s11356-017-0377-4
  5. Celeiro M, Dagnac T, Llompart M. Determination of Priority and other Hazardous Substances in Football Fields of Synthetic Turf by Gas Chromatography-Mass Spectrometry: A Health and Environmental Concern. Chemosphere. 2018;195:201-211. https://doi.org/10.1016/j.chemosphere.2017.12.063
  6. 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
  7. Perkins AN, Inayat-Hussain SH, Deziel NC, et al. Evaluation of Potential Carcinogenicity of Organic Chemicals in Synthetic Turf Crumb Rubber. Environmental Research. 2019;169:163-172. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6396308/

Dr. Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants


Statement of Dr. Diana Zuckerman, President, National Center for Health Research on October 23 Regarding FDA Labeling Recommendations to Improve Patient Communication Draft Guidance

We thank the FDA for proposing a black box warning and a patient Informed Consent check list that provides specific, understandable information about the risks of breast implants.  The FDA’s draft includes the types of information that we have proposed to the FDA in recent months in our work with patient advocates and plastic surgeons.  The devil is in the details, so we look forward to working with the FDA to finalize these materials so that patients can make better informed decisions in the future than most women considering breast implants have been able to make. We will  keep working closely with the FDA, patients, and plastic surgeons to make that goal a reality.

For more information see FDA’s Draft Guidance here.

NCHR Letter to Mayor Cohn and Members of the Rye City Council Concerning Artificial Turf and Playgrounds

National Center for Health Research, October 16th, 2019


Dear Mayor Cohn and Members of the Rye City Council:

I am writing on behalf of the National Center for Health Research.  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 have been contacted by families in Rye who are concerned about the risks of artificial turf and playgrounds. We are impressed with their knowledge and agree with them that converting grass fields to artificial turf poses unnecessary dangers to children in your community.

As a scientist who has worked on health policy issues for more than 30 years, I don’t shock easily.  However, it is shocking and disturbing that artificial turf athletic fields and playgrounds are exposing children on a daily basis to chemicals and materials that are known to have the potential to increase obesity; contribute to early puberty; cause attention problems such as ADHD; harbor deadly bacteria; exacerbate asthma; and eventually cause cancer.

Federal agencies such as the EPA and the U.S. Consumer Product Safety Commission have been investigating the safety of these products. A recently released EPA report found toxic chemicals in artificial turf, but did not evaluate whether or not the level of exposure would harm children.  Despite claims to the contrary, no federal agency has concluded that artificial turf is safe.

Scientific Evidence of Cancer and Other Systemic Harm

First, it is important to distinguish between evidence of harm and evidence of safety.  Companies that sell and install artificial turf often claim there is “no evidence that 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.

The artificial turf industry will tell you there is no clear evidence that their fields caused any child to develop cancer.  That is true, but 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).

Most research has focused on the risks of infill made from recycled tire waste. However, recent research has indicated the presence of dangerous levels of chemicals in the plastic blades of grass as well as in the tire waste. So, even if the infill is replaced with a safer materials, the plastic grass carpet itself is dangerous.

We know that the materials being used 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 Rye or any other community choose to spend millions of dollars on fields that are less safe than well-designed natural grass fields?

Synthetic rubber and plastic are made with different types of endocrine (hormone) disrupting chemicals as well as carcinogens.  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). [1]

A 2015 report by Yale scientists detected 96 chemicals in samples from 5 different artificial turf companies, including unused bags of tire crumb. 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 on the impact of hormone-disrupting chemicals (also called endocrine disrupting chemicals or EDCs), and the evidence is clear that these 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, have been banned for more than a decade, even though they would result in very short-term exposures compared to artificial turf.

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, EDC 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.

Envirofill and Alternative Infills

Artificial turf fields are often 50-70 degrees hotter (or more) compared to grass fields, and this can be dangerous for children on a warm day.  Envirofill artificial turf fields is advertised as “cooler” and safer than tire crumb, 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.

In addition, the Envirofill pellets 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 instead of tire crumb and other very controversial materials.  However, all the materials being used (such as volcanic rock, corn husks, and Corkonut) have raised concerns and none are proven to be as safe or effective as well-designed grass fields.  And as noted above, the plastic grass itself is made from dangerous chemicals.

Dangerously Hard Fields, Turf Burns, and Hot Fields

I want to briefly mention safety issues pertaining to Gmax scores.  A Gmax score measures how hard a field is, specifically regarding brain injuries.  A score over 200 is considered extremely dangerous and is considered by the synthetic turf industry to pose a death risk.  However, the synthetic turf industry and ASTM (American Society for Testing and Materials), suggest scores should be even lower — below 165 to ensure safety comparable to a grass field.

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, and 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 that is the way safety is determined.

In addition to hard fields, artificial turf is more likely to cause “turf burns” which can be very painful and can get infected.  There is a good reason why almost all professional baseball parks use grass rather than artificial turf, and why professional football and soccer teams also prefer natural grass.

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, UV inhibitors, etc., which can be toxic to marine and aquatic life; and microplastics are known to migrate into the oceans, food chain, and drinking water and can absorb and concentrate other toxins from the environment. [7,8,9]

As noted above, artificial turf gets much hotter than grass, and so does the air above it.  Synthetic surfaces 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, and abate noise and reduce glare. [12]

Conclusions

There are currently no safety tests required prior to sale that prove that any artificial turf products are safe.  In many cases, the materials used are not made public, 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 I can attest to the fact 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 or 202 223-4000).

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 can save lives and improve the health of children in Rye and will serve as a model to other communities.

Officials in communities all over the country have been misled by artificial turf salespeople. They were erroneously told that these products are safe.  But on the contrary, there is clear scientific evidence that these materials are potentially harmful. The only question is how harmful and how much exposure is likely to be harmful?  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. Yale Study Reveals Carcinogens and Skin Irritants in Synthetic Turf. http://wtnh.com/2015/09/03/new-yale-study-reveals-carcinogens-and-skin-irritants-in-synthetic-turf/
  3. Anderson SE and Meade BJ, Potential Health Effects Associated with Dermal Exposure to Occupational Chemicals, Environ Health Insights. 2014; 8(Suppl 1): pgs 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. Int J Environ Res 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. Phil Trans R Soc 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. Philos Trans R Soc Lond B. 2009. 364: 2153–2166.
  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

NCHR Comments on FDA’s Draft Guidance on Enhancing the Diversity of Clinical Trial Populations

National Center for Health Research; August 6, 2019


National Center for Health Research’s Public Comments on
Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria,
Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability
[FDA-2019-D-1264]

Thank you for the opportunity to express our views on the critical issue of increasing diversity in clinical trials, and how FDA should be addressing this longstanding issue through guidance to its Centers and broadening clinical trial eligibility requirements.

The National Center for Health Research (NCHR) is a non-profit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety.  We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

For many years, NCHR has been strongly encouraging FDA to expand the diversity of clinical trials for drugs and medical devices to include more elderly patients, women, children, and individuals from a broad variety of racial and ethnic groups.  Too frequently, trials of drugs and devices which lead to FDA approval are still conducted mainly on white adults under the age of 65.  In some cases, treatments intended for men and women are primarily tested on one or the other, and not analyzed separately by sex.   In 2012, Congress passed a law urging the FDA to do a better job of expanding clinical trial participants to take into account the factors of age, race and ethnicity, and sexual differences.

There are reasons why a drug or device may be less safe or less effective for women, children, older patients, or certain ethnic or racial subgroups.  These differences in results for under-represented subgroups may not be minor or trivial.  According to a review of 167 new molecular entities approved by FDA between 2008 and 2013, approximately 20% had differences in exposure or response across racial or ethnic groups, or both.1

Lack of diversity in clinical trials has real world consequences on the knowledge about the effectiveness and safety of medical products.  Our research has identified several products that were less effective for certain subpopulations, which have important implications for clinicians and patients in choosing appropriate care.  In addition, the lack of age-related data has enormous consequences for Medicare, which is required to cover substantial costs for medical products that have not been studied on more than a few patients who were over 65.  Such lack of meaningful age-related testing results in the waste of many millions of taxpayer dollars on ineffective or even adverse medical outcomes.

In its proposed draft guidance, FDA has recognized the need to broaden eligibility criteria in order to increase diversity in enrollment.  However, there has not been sufficient incentive for drug and device sponsors to actively recruit more women, minority patients, children, and older patients.  In the past, FDA focused on the need for patient groups to encourage under-represented demographic groups to apply to clinical trials, rather than focusing on what companies should do to recruit under-represented patients to participate.  What is needed is an incentive for companies to ensure diversity, and the most effective incentive is if the FDA makes it clear that the agency will not approve medical products for all populations if the product was not tested for safety and efficacy on sufficient numbers of patients representing major demographic subgroups.

Certainly FDA’s draft guidance recommendation to make trial participation less burdensome for participants is a positive step, but that in itself will not result in the recruitment of a broader section of demographic subgroups who have been too often largely excluded in the past.  However, advising potential trial participants of possible reimbursement of travel and other trial expenses, as FDA’s draft guidance also recommended, may well help recruit older patients, parents of young children and caretakers of family members, and others who may otherwise lack the financial resources to enable them to participate in clinical trials.

We agree that measures to adopt enrollment and retention practices that enhance inclusiveness as outlined in the draft guidance should have a positive impact on the recruitment of broader demographic subgroups.  However, these should be “strongly encouraged” and not simply “considered.” The same is true for the recommendations for trial design and methodological approaches, which are also intended to broaden clinical trial participation.  The lack of meaningful incentives for sponsors to broaden clinical trial eligibility and recruitment has been a primary cause of why these various subgroups have remained under-represented for so long.

FDA issued a 1993 guidance for the inclusion of women trial participants in the clinical evaluation of drugs, and that situation has improved although more needs to be done in terms of using the data to restrict labeled indications when appropriate.  NCHR was critical of the 2014 FDA Action Plan for efforts to include more elderly patients in clinical trials as lacking in specificity.  This latest draft guidance is a chance for the agency to rectify these clearly identified and longstanding shortcomings.

The agency’s work with the Office of Minority Health, the HHS Office for Human Research Protections, and NIH, as well as the FDA Consumer page, indicates progress in improving enrollment diversity practices in clinical trials.  But our research indicates that much remains to be done.

We also point out that while this guidance pertains to CDER and CBER, diversity in clinical trials is also essential for medical devices, particularly implants.  Our research on devices approved through the PMA pathway following Advisory Committee consideration in 2014-2017 found numerous devices were tested primarily on white patients.2  For devices that included information about race, white participants made up 69%-99% of participants.  Most devices did not include information about the number of participants over the age of 65 years and many did not specify the range of ages of participants in trial(s).

In addition, of devices intended for both men and women, 45% (9/20) of devices were approved based on pivotal trials where less than 35% of participants were of the minority gender.  The implications of lack of diversity in clinical trials for high-risk medical devices are important.  For example, Lutonix, a drug-coated balloon catheter used to open a blocked artery, was found to be beneficial for men but not women; women’s outcomes were better with of the control balloon catheters.  A colorectal cancer test, Epi proColon, was, even though it was less accurate for patients older than 69 years of age than for patients less than 60 years old.  It was also found to be less accurate for black patients compared to white.

Thank you for the opportunity to comment on this important medical and patient issue.

National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.

References

  1. Ramamoorthy A, Pacnowski MA, Bull J, Zhang L. Racial/ethnic differences in drug disposition and response: Review of recently-approved drugs. Clinical Pharmacology & Therapeutics. 2015;97(3):263-273. https://www.ncbi.nlm.nih.gov/pubmed/25669658
  1. Fox-Rawlings SF, Gottschalk L, Doamekpor LA, Zuckerman D. Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients? Milbank Quarterly.2018;96(3):499-529. https://onlinelibrary.wiley.com/doi/abs/10.1111/1468-0009.12344

 

NCHR Statement on FDA’s Request for Recall of Allergan Breast Implants and Expanders


Statement of Dr. Diana Zuckerman, President, National Center for Health Research on July 24 Announced Recall of Allergan Biocell Breast Implants and Expanders

h Research on July 24 Announced Recall of Allergan Biocell Breast Implants and Expanders

“The FDA announced today that at its request, Allergan is implementing a worldwide recall of their Biocell textured breast implants and expanders.  This recall is an important step toward reducing the risk of a type of cancer of the immune system called Anaplastic Large Cell Lymphoma (ALCL) caused by breast implants.  Many other countries had already banned this type of Allergan textured breast implant, but the FDA had previously stated that such a ban was premature.  However, it was inevitable that either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so.  It is a little surprising that the FDA is taking credit for the recall, since most recalls of medical devices are described by the companies as voluntary.

“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma.  This recall will reduce that risk but it won’t eliminate it.”

For more information, see the FDA’s Press Release here.

The Breast Implant Working Group’s Breast Implant Black Box Warning and Patient Checklist

The Breast Implant Working Group’s Breast Implant Black Box Warning

This black box warning was developed by the Breast Implant Working Group, which consists of Dr. Diana Zuckerman (National Center for Health Research), Dr. Scot Glasberg  American Society of Plastic Surgeons), Dr, Alan Matarasso (also ASPS), Jamee Cook (Breast Implant Victim Advocacy), Raylene Hollrah (Just Call me Ray), and Karuna Jaggar (Breast Cancer Action).   As individuals, we are urging the FDA to include a black box warning about the risks of cancer and other serious health problems for women considering breast implants.

BLACK BOX WARNING: Breast implants can cause a type of cancer of the immune system called BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma).  People with silicone or saline breast implants have developed this rare disease, which can be deadly if not treated early. Almost all women who have developed BIA-ALCL have had textured breast implants or expanders at some point.

Several studies also suggest that women with breast implants have a small but significant increase in their chances of developing certain autoimmune or connective tissue diseases. Women with silicone gel or saline breast implants have reported symptoms that are sometimes serious, such as joint or muscle pain, fibromyalgia, mental confusion, and painful skin conditions.  Many of these symptoms improve partially or completely when their breast implants are removed and not replaced.

The Breast Implant Working Group’s Patient Informed Consent Checklist

This checklist was developed by the Breast Implant Working Group, which consists of Dr. Diana Zuckerman (National Center for Health Research), Dr. Scot Glasberg (American Society of Plastic Surgeons), Dr, Alan Matarasso (also ASPS), Jamee Cook (Breast Implant Victim Advocacy), Raylene Hollrah (Just Call me Ray), and Karuna Jaggar (Breast Cancer Action).  The checklist has been endorsed by their organizations, as a requirement to be read and signed by all potential breast implant patients.

See the checklist here or below:

BREAST IMPLANT PATIENT/DOCTOR CHECKLIST 

The purpose of this checklist is to provide information for patients considering breast implants for augmentation or reconstruction, so that they can carefully weigh the risks and benefits of breast implants and make the decision that is right for them. The risks in this checklist are in addition to common surgical risks such as infection, necrosis (skin death), or problems with anesthesia.

After reviewing the Patient Information Booklet, please read and discuss the items in this checklist with your surgeon. You should not initial or sign the document, and should not undergo the procedure, if you do not understand each of the issues listed below.

How long do breast implants last? I understand that breast implants are not expected to last for the rest of my life.  Implants may rupture or leak at any time, and that is more likely the longer you have them.  In addition, it is likely that I will need other surgeries related to my breast implants over the course of my life.  If I am a cosmetic surgery patient, my health insurance policy may refuse to cover these surgeries. These additional surgeries and procedures can include implant removal with or without replacement, muscle and tissue repair, scar revisions, MRI diagnostic exams, or other procedures. I understand that undergoing multiple surgeries may increase my chances of permanent breast deformity.

Patient Initials____________

Who shouldn’t get breast implants?  I understand that the safety of breast implants was never studied for people who have autoimmune symptoms or diseases, or a family history of those diseases. Breast implants may be more likely to cause serious health problems and symptoms for these people.  In addition, breast implants may not be safe for anyone with a weakened immune system or certain genetic risk factors that have not yet been identified.

Patient Initials____________

Chemicals and Metals in Breast Implants:  I understand that all breast implants contain chemicals and small amounts of heavy metals that may cause health problems. I understand that most of these chemicals are confined to the shell of the implant or stay inside the shell.  However, small quantities have been found to diffuse (bleed) from or through the implant shell, even if the implant is intact and not ruptured.

Patient Initials____________

Rupture and Leakage:  I understand that the longer my breast implants are in place, the more likely they are to rupture, especially after the first few years. When a saline implant ruptures, it usually deflates quickly. When a silicone gel implant ruptures, I may not notice any changes and the rupture may not be detected by my doctor or by mammogram, MRI, or sonogram. I understand that an MRI is recommended for silicone gel breast implants 3 years following surgery and every 2 years after that to check for silent rupture, and that these MRIs often are not covered by health insurance. I understand that silicone may migrate from the implant into nearby tissues such as the chest wall, lymph nodes, upper abdominal wall, and into organs such as the liver or lungs where it cannot be removed. Since migrated silicone can cause health problems, it is currently recommended that any ruptured silicone implant should be removed as soon as possible. I understand that, if needed, treatment of these conditions may be at my own expense and not covered by insurance or a manufacturer warranty.

Patient Initials____________

BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma):  I understand that there is a small risk for me to develop BIA-ALCL, a cancer of the immune system. BIA-ALCL is a type of lymphoma that develops on or around the scar capsule that surrounds the breast implant. I understand that the symptoms of BIA-ALCL include breast swelling, lumps, pain, and asymmetry that develop after surgical incisions are completely healed, usually years after implant surgery.

Treatment for BIA-ALCL includes removal of the implant and scar capsule, and, if not treated early, may include chemotherapy and radiation. This diagnosis and treatment may be at my own expense and is not always covered by insurance.

Patient Initials________________

Symptoms of “Breast Implant Illness:” I understand that because of the lack of long-term safety data, we are still learning about the health problems that result from breast implants.  To date, thousands of women have reported to the FDA or to researchers that they have experienced serious health problems that several studies have linked to their breast implants. This may occur either immediately after getting implants or years later. These often include symptoms such as: joint and muscle pain or weakness, memory and concentration problems, chronic pain, depression, fatigue, chronic flu-like symptoms, migraines, or rashes and skin problems.

Several studies of women with breast implants have shown that they are significantly more likely to be diagnosed with one or more of the following diseases compared to other women: • Chronic Fatigue Syndrome • Multiple Sclerosis (MS) • Rheumatoid Arthritis (RA) • Sjögren’s syndrome  • Systemic Sclerosis/Scleroderma

Although women who develop these symptoms or diseases can’t be certain that they were caused by breast implants, several studies indicate that most symptoms improve partially or completely after having their implants and capsules removed.

Patient Initials____________

Capsular Contracture:  I understand that one of the most common complications of breast implants is when the scar tissue capsule that forms around the implant hardens. In some cases, this can be quite painful, distort the shape of the breast, and can make mammography more painful and less accurate. Removing the implant and capsule without replacing the implant is the only recommended way to guarantee that this problem is corrected.

Patient Initials____________

Breast Cancer:  I understand that all breast implants can interfere with mammography and breast exams, possibly delaying the diagnosis of breast cancer. I understand that if I get breast implants, I should inform the mammography technologist about the implants and ask for additional views to improve the accuracy. I understand that mammography can also cause the breast implant to rupture or leak.

Patient Initials____________

Interference with Breastfeeding:  I understand that breast implants and breast surgery may interfere with my ability to successfully breastfeed.  No long-term research has been conducted to determine the possible transmission of chemicals and heavy metals in the breast milk of women with implants.

Patient Initials____________

Loss of Sensation to Breast or Nipple(s): I understand that breast implants and breast surgery may cause the nipple or breast to be painful, or to have decreased sensation. These changes may be temporary or permanent, and may affect sexual response or the ability to nurse a baby.

Patient Initials____________

Cosmetic Complications:  Asymmetry, Implant Displacement, Ptosis I understand that if my breasts had slightly different shapes before surgery, they may remain slightly different after surgery. I understand that the implants may cause the breasts to look slightly different in size or shape. I understand that the implant may move from the original placement location and that may result in asymmetry or other cosmetic problems. Breast implants can cause the breasts to sag over time due to the weight of the implants. I understand that if I am not happy with the results, I may need future surgeries to improve the appearance of my breasts.

Patient Initials____________

CONFIRMATION OF DISCUSSION OF RISKS 

Patient: I acknowledge that I have received and read the Breast Implant Patient Information Booklet and this checklist. I have had time to discuss the information in both with my doctor, and understand the benefits and risks of the implants and surgery.

______________________________________________Patient Signature & Date

Physician: I acknowledge that I have discussed the benefits and risks of breast implants as described in the Breast Implant Patient Information Booklet and this checklist. I have encouraged the patient to ask questions, and answered all questions accurately.

____________________________________________Physician Signature & Date

NCHR Public Comment to FDA on breast implant safety

National Center for Health Research, April 26, 2019


National Center for Health Research Public Comment on General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting [FDA-2019-N-0426].

Thank you for the opportunity to provide comments on FDA’s General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee meeting on breast implants. The
National Center for Health Research is a nonprofit research center staffed by scientists, medical professionals, and health experts focused on research, programs, services, and policies that affect public health. Our Center analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from companies that make medical products, so we have no conflicts of interest.

Our Program to Help Women Seeking Insurance Coverage for Implant Removal

Since its founding in 1999, our Center has heard from thousands of women who told us that their breast implants have caused serious health problems. In 2015, we began to offer a program that helps women navigate their health insurance policies so that they can get coverage when the removal of breast implants is medically necessary. In the past 3 years, more than 6,000 women have contacted us, and the number continues to grow dramatically. Some weeks we are contacted by more than 200 new women seeking our help to get their breast implants removed because of serious medical problems. Their reasons for needing their implants removed include leaking and ruptured breast implants, chronic pain from capsular contracture or from implants that are too large, autoimmune or connective tissue symptoms or diseases (referred to as “breast implant illness”), and ALCL. Some women contact us after recently developing symptoms from their breast implants, while others have been living with chronic health issues for years but either did not know they might be related to their breast implants or did not have the financial resources to have their implants removed. Prior to passage of the Affordable Care Act, breast implants were considered a “pre-existing condition” and explant surgery was almost never covered by health insurance.

Most women tell us that had they known that breast implants might cause these serious health problems, they never would have gotten them. We hear every day how women trusted their doctors when they were told that breast implants were safe and that complications were rare.

Recent research on 123,255 Israeli women by Watad et al. concluded that breast implants
significantly increase the chances of a woman being diagnosed with several autoimmune
diseases, such as rheumatoid arthritis and Sjogren’s Syndrome. However, because the FDA has repeatedly denied a link between autoimmune or connective tissue symptoms and breast implants, insurance companies will rarely pay for the removal of implants for women with symptoms of breast implant illness, such as joint or muscle pain, chronic fatigue, mental confusion, rashes, hair loss, and persistent flu-like symptoms. Of the thousands of women who seek assistance from our organization, only about 20% are able to get their implants removed. Even fewer get insurance coverage for their medically necessary explant surgery. The rest have to empty their savings, rely on credit cards or loans, or borrow money from friends and family. Unfortunately, most women who are unable to get insurance coverage for their breast implant removal are also unable to afford to pay out-of-pocket for explant surgery, which is why so many live with debilitating symptoms and escalating health problems for years. What might start as gradual increases in symptoms become so debilitating that many of the women lose their jobs (and with it, often their insurance), their ability to care for themselves or their families, and sometimes their spouses.

Implications for the Registries

The PROFILE Registry is intended to gather information about patients with BIA-ALCL, but not other health problems. The National Breast Implant Registry is designed to include as many Board-Certified plastic surgeons and their patients as possible, and therefore focuses only on re-operations – information that is relatively easy for physicians to document. It does not include information about the range of life-changing symptoms that thousands of women have reported, and also fails to include the thousands of women who need to have their implants removed, but are financially unable to do so. As we have found in our program assisting women who desperately seek insurance coverage for explant surgery, the number of women who have their implants removed and not replaced is only a small percentage of the number of women who want explant surgery because of medical problems. The registry needs to be substantially improved by including information about the autoimmune and connective tissue disease diagnoses as well as the moderate to severe symptoms that women refer to as breast implant illness. In addition, registries need to include information from primary care physicians and non-surgical specialists who are often conducting medical tests in an effort to determine the cause of the women’s symptoms. Most women who experience autoimmune or other symptoms from their breast implants are making appointments with primary care physicians, rheumatologists, neurologists, and other specialists; they rarely return to their plastic surgeons because those symptoms aren’t clearly related to their implants. Moreover, they tell us that when they go to a plastic surgeon because they have heard from other patients that the symptoms may be related to their implants, most surgeons tell them they are mistaken.

Another major shortcoming of the current Registry is that the data from the Registry is not
available to researchers or the public unless the ASPS Foundation chooses to make it public. Since the FDA considers registries an important aspect of post-market surveillance, it is essential that the data be available to anyone who wants to analyze it.

If Implants Can Cause Serious Symptoms, Will Removal Improve Health?

Our Center recently conducted a study of 449 women who had sought our help and succeeded in having their implants removed in 2016, 2017, or 2018. Fifty-seven percent of the women filled out our online questionnaire, all between November 2018 and January 2019. All of the women who we contacted had provided medical information to us when we had previously tried to help them obtain insurance coverage for explant surgery. Fifty-nine percent of the women in the study had symptoms for more than 5 years before they had their breast implants removed and 25% reported having symptoms for more than 10 years before explant surgery. These findings are consistent with patients’ testimony at the FDA meeting and with what thousands of patients have told us over the years: Many women have had debilitating symptoms for years, but did not know they were linked to their breast implants. So, instead of removing their implants when they first noticed health problems, they waited years, and sometimes decades, to seek explant surgery without replacement. Whether because of lack of money or lack of information that their symptoms were caused by their implants, our findings suggest that a short, easy-to-understand booklet and informed consent checklist could help warn women with limited financial resources about the risks of breast implants and also help women recognize their symptoms and consider explant surgery as an option before their health deteriorates.

We asked about family and personal health history and found that 69% of the women in our study reported a family history of autoimmune disease, 3% reported a personal history of autoimmune symptoms prior to getting implants, and 51% of the women reported that they were newly diagnosed with an autoimmune disease after getting breast implants.

Using a Likert scale with responses ranging from “much worse” to “much better,’ 61% of the women reported that their symptoms were much better since getting their implants removed and an additional 29% reported that their symptoms were somewhat better after having their breast implants removed. After performing a logistic regression to determine the factors that independently predicted health improvement after explant surgery, having explant surgery that removed as much capsule as possible predicted improvement after explant, as did not having a family history of autoimmune disease.

Implications for Informed Consent

Although all implant companies have patient booklets, in our experience most women report never seeing those booklets. In addition, the booklets are much too long and technical; they range in length from 55 to 180 pages, and include a great deal of information that is difficult to understand or promotional rather than informational. Nevertheless, the patient booklets include important information, such as the warning that breast implants were not studied on women with a history of autoimmune disease and therefore the safety of implants is not established for those women. However, there is so much information in these lengthy booklets that these types of important warnings are unlikely to be noticed by either doctors or patients that read them.

Although all patients sign an “informed consent” document, many are too technical for the
average patient to understand and include information that may be vague or confusing. They are often signed without having been carefully read. Informed consent is supposed to be a process, not just a piece of paper. Patients tell us that regardless of what the informed consent forms stated, their plastic surgeons were very reassuring about how safe implants are, rather than being candid about the risks. At the FDA Advisory Committee meeting on March 25-26, many plastic surgeons spoke about how carefully they provide informed consent to their patients, but those claims were undermined by the fact that many of those same surgeons stated that their patients are very happy with their implants, that ALCL is very rare and ‘not a big deal’ if caught early, and that the symptoms of breast implant illness are the same symptoms that all women tend to have. It is obvious that these physicians are unable to provide objective, informed consent about risks if they think the risks are minimal or non-existent.

Improving Informed Consent

Women need better informed consent in terms of written material and in terms of what their physicians tell them. Patient booklets specific to each company and implant model should be no longer than 20 pages and written at an 8th grade reading level, which is the reading level recommended by health educators. They should include easy-to-understand information about complications and risks, including information about BIA-ALCL and symptoms of breast implant illness. They should also include information from studies indicating that many women with breast implant illness experience significant improvement when their implants and scar capsules are removed. The writing of these booklets should require consensus among a group of experts that includes patients harmed by implants and their physicians, Board-certified plastic surgeons who put in breast implants and Board-certified plastic surgeons who primarily explant, the relevant implant manufacturer, and health educators.

In addition, there should be a required checklist, no longer than 3-4 pages, that is similar to the one that the FDA required for Essure, that provides information about the potential risks of all breast implants including BIA-ALCL and breast implant illness. These should be read and signed by patients and their doctors prior to any nonrefundable deposits for surgery. The checklist should include a black box warning regarding BIA-ALCL and breast implant illness, and information about the potential improvement in health for women who have their implants removed and not replaced.

In conclusion, we urge the FDA to require an informed consent checklist that specifically and succinctly warns of the symptoms and disease development risks that the patients at this meeting have reported. We ask that the FDA require manufacturers to complete the large, long-term studies that evaluate systemic symptoms. And finally, we urge the FDA to develop a national registry that includes symptoms as well as re-operations.

Thank you for the opportunity to comment on this important issue.

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

Cancer Prevention and Treatment Funds’ Comments On USPSTF Draft Recommendation Statement for BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing

March 18th, 2019


We are pleased to have the opportunity to express our strong concerns about the draft recommendations for risk assessment, genetic counselling, and genetic testing for BRCA-related breast cancer. The Cancer Prevention and Treatment Fund is a nonprofit program that conducts, analyzes, and reviews research, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from pharmaceutical companies and have no financial ties to this issue.

We have concerns about the familial risk prediction methods and the baseline mutation probability threshold being used to refer large numbers of women for genetic counselling and potentially genetic testing.

According to the CDC[1], 1 in 40 Ashkenazi Jewish women have the BRCA mutation. Based on most of these models, most 30-year-old Jewish women with any first- or second-degree family history of breast cancer would likely be referred for genetic counseling, and yet 90% will not have a BRCA mutation.  This will clearly raise anxiety levels and we question whether the benefits outweigh those concerns.

Studies have shown that applying a seemingly universal mutation probability threshold of 10% for almost all risk prediction models will lead to a phenomenon called ‘over-dispersion.’  This means that those who are most likely to be carriers will have a very high probability prediction and those who are least likely to be carriers will have very low probability estimation.[2] Statistically, this often provides misleading and conflicting results to physicians.

Additionally, further research on the validation of risk prediction models has shown that the decision threshold should be derived from “diagnostic accuracy measures rather than defined directly by any breast cancer risk.”[3] Science has shown that tests in clinical settings with a high sensitivity are more likely to detect a higher number of carriers ultimately reducing the burden of unnecessary medical expense.3

Therefore, we urge the USPSTF to reconsider its assessment of the risk prediction models by employing a universal standardized sensitivity threshold instead of a universal standard mutation probability threshold. A universal sensitivity for all predication models will yield varying but statistically relevant mutation thresholds for different models. This will more accurately identify mutation carriers in need of genetic counselling and reduce the overall number of non-carriers who are sent for genetic counselling.

For questions or more information, please contact Dr.Varuna Srinivasan, MBBS, MPH at vs@center4research.org.

[1] Center for Disease Control and Prevention,  Jewish Women and BRCA Gene Mutations, www.cdc.org, https://www.cdc.gov/cancer/breast/young_women/bringyourbrave/hereditary_breast_cancer/jewish_women_brca.htm, November 5th 2018

[2] Lindor, N. M., Lindor, R. A., Apicella, C., Dowty, J. G., Ashley, A., Hunt, K., Mincey, B. A., Wilson, M., Smith, M. C., … Hopper, J. L. (2007). Predicting BRCA1 and BRCA2 gene mutation carriers: comparison of LAMBDA, BRCAPRO, Myriad II, and modified Couch models. Familial cancer, 6(4), 473-82.

[3] Schneegans, S. M., Rosenberger, A., Engel, U., Sander, M., Emons, G., & Shoukier, M. (2011). Validation of three BRCA1/2 mutation-carrier probability models Myriad, BRCAPRO and BOADICEA in a population-based series of 183 German families. Familial cancer, 11(2), 181-8.