June 13, 2022.

National Center for Health Research’s Comments on Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials [FDA-2021-D-0789]

We are writing to express our views on the Food and Drug Administration’s (FDA) draft guidance to provide recommendations to sponsors developing medical products on the approach for developing a plan to enroll representative numbers of participants from underrepresented racial and ethnic populations.

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 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 strongly support the proposed recommendations which provide specific, actionable guidance for sponsors to develop a meaningful Race and Ethnicity Diversity Plan. In particular, we appreciate the proposed recommendation for sponsors to clearly define and justify enrollment goals for underrepresented racial and ethnic minority populations. Most important, representation in a trial must be adequate to conduct appropriate subgroup analyses on efficacy and safety. For example, if a minority group is 20% of the patient population but there are only 100 patients in the entire study, 20 patients would be 20% but would not be sufficient to determine safety or efficacy for that group.

It is thus encouraging that the draft proposal recommends that sponsors provide any available evidence describing disparities in health outcomes related to the drug or therapy, but acknowledges that the lack of this evidence should not be grounds to ignore the importance of diversity.  For too long, many clinically meaningful disparities in the efficacy of drugs or therapies in minority populations have been hidden by a lack of data. Thus, it is crucial to ensure that sponsors describe existing research on similarities and differences in how the disease or condition under study is experienced by racial and ethnic minorities, and identify potential gaps in existing data.

The goal is for the inclusion of these recommendations to improve the accountability of sponsors to make real and sustainable improvements in the representation of minorities in trials. However, to truly hold sponsors accountable, this draft proposal should go further by providing meaningful incentives for sponsors to follow the recommendations outlined. The most meaningful incentive within current law would be that FDA make it clear that the agency will not approve medical products for all populations if the product was not adequately tested for safety and efficacy on sufficient numbers of patients representing major demographic subgroups.

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

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. 

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.

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 known total was increased to 1,130 in 2022.

In September 2022, the FDA announced new information about other cancers related to breast implants: various other lymphomas as well as squamous cell carcinoma. At the time of the announcement, the FDA had received 10 reports about breast implant-related SCC and 12 reports about lymphomas other than ALCL. Like BIA-ALCL, these cancer cells all were found in the scar capsule surrounding the breast implant, which is why experts believe the implants are the cause.  The implants involved were saline and silicone, textured and smooth.

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?

A 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.

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

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

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