Public Comments by Women’s Health Experts on General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting

National Center for Health Research Public Comment on General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.

Thank you for the opportunity to provide comments on FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.

We are writing on behalf of five nonprofit health organizations that have examined issues pertaining to women’s health for decades and have considerable expertise concerning breast implant safety issues. None of these organizations have financial or professional conflicts of interest pertaining to breast implant devices or surgery:

  • Breast Cancer Action is a national nonprofit grassroots membership organization with members across the country who are challenging the status quo and working to address and end the breast cancer epidemic.
  • The Jacobs Institute of Women’s Health identifies and studies aspects of healthcare and public health, including legal and policy issues, that affect women’s health at different life stages.
  • The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety.
  • The National Women’s Health Network (NWHN) is a non-profit advocacy organization that works to improve the health of all women by supporting informed consumer decision-making.
  • Our Bodies Ourselves is a nonprofit educational and advocacy organization that has advanced the health and human rights for girls and women for almost 50 years.

As a follow-up to the FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting on breast implants, we are writing to express our views and concerns about the current status of information about breast implants and the role of the FDA in regulating the devices.

1. There is insufficient research to determine the long-term safety of breast implants. The clinical trials submitted to the FDA have numerous shortcomings:

  1. They excluded women with a history of autoimmune disease.
  2. They had an unacceptably high “loss to follow-up.” At the FDA meeting, FDA scientists presented data from studies that had lost up to 85% of the patients to follow-up, even in the revised studies that had already eliminated the 95% of patients who had dropped out. Those revised studies were already hopelessly biased, and presenting the data as if it were meaningful was unacceptable. And, the numbers of patients were also unacceptably small in many cases, with several reconstruction and revision patient groups represented by less than a dozen patients. Accurate information on the safety of breast implants cannot be gleaned from studies with such inadequacies.

The studies of autoimmune and connective tissue disease funded by industry and plastic surgeons had a different set of problems:

  1. Many included small number of patients, some of whom had breast implants for short periods of time, ranging from one month to just a few years. This is not relevant to long-term safety issues, since implants tend to deteriorate and rupture over time.
  2. They evaluated the number of women with diagnoses of rare diseases, but did not include women with symptoms of those diseases, nor did they have the statistical power to evaluate significant differences between women with implants and women without implants.
  3. Many evaluated the number of women hospitalized with those rare diseases or whose medical records specified those diseases, but the studies included women who had implants for such a short time that it was unlikely that the women had yet been diagnosed or hospitalized.

2. Most women do not receive objective informed consent regarding the risks of breast implants during the decision-making process. When the FDA approved breast implants, the agency required that plastic surgeons share information about the risks in a patient booklet. Unfortunately, most women say that they do not receive these booklets prior to surgery, and the booklets themselves are too long and complicated to provide useful information to patients. For example, although the patient booklets warn that the safety of breast implants have not been studied in women with a history of autoimmune disease, that information is difficult to find in these 44-202 page patient booklets.

3. To improve informed consent, women considering breast implants need a shorter, easy to understand patient booklet, which harmed patients should help to write. These booklets should include quantitative data on risks of the company’s implants for augmentation patients and reconstruction patients that are easy to understand. As experts in educating women on health issues, we would be glad to participate in writing these booklets as well. In addition, we strongly urge that the FDA require a short, user- friendly check list that provides balanced information about the risks, similar to the 3- page check list that the FDA required doctors and their patients to sign to inform them of the possible risks of Essure. The current informed consent checklists provided by some implant companies are vague consent forms rather than specific information acknowledging the risks. Informed consent checklists should explain all of the associated risks, encourage informed and shared decision making by the patient, and ultimately prevent long-term harm. It should clearly and succinctly state the risks that can occur with breast implants, including BIA-ALCL, the possibility of autoimmune symptoms, the need to remove the implants as they age and rupture, and the cost of MRI screening for silent rupture. The checklist should include a black box warning about BIA-ALCL and breast implant illness. The checklist should also include information based on studies indicating that women with breast implant illness are significantly more likely to improve after their implants and capsules are removed.

4. Since almost all cases of BIA-ALCL are associated with textured breast implants, implant companies that make textured implants should be required to conduct large retrospective studies to evaluate if the implants have any benefits compared to smooth implants. Some plastic surgeons believe that textured implants are less likely to cause capsular contracture and some other problems, but the FDA has not vetted any data to support those claims. Similarly, the use of mesh in breast reconstruction has not been scientifically studied to determine risks or benefits, and FDA should add warnings to the label and the FDA website about that off label use. In the meantime, textured breast implants should carry a black box warning about BIA-ALCL and that information should be provided orally and in writing to all women considering implants.

5. The newly designed breast implant registry tracks only the rates of reoperation, not other complications or health problems of women with breast implants. In addition, the National Breast Implant Registry misses the thousands of women who need to have their implants removed, but are financially unable to do so. To provide useful information, the registry should include information about important, debilitating autoimmune and connective tissue disease symptoms associated with implants. Registries should include relevant medical information from physicians other than plastic surgeons. In addition, the data from the registry are not available to the public unless the plastic surgeons chose to publish information. To improve transparency and informed decision- making by physicians and patients, data from the registries should be made available for free to the FDA, independent researchers, and the public to be analyzed and published.

6. We strongly urge the FDA to require manufacturers to complete large, long-term studies that evaluate the serious symptoms that patients described at the FDA Advisory Committee meeting. Well-designed studies were required as a condition of approval more than a dozen years ago, but those studies were not properly completed, due to enormous loss to follow-up. The FDA should require such studies now, and this time the research requirements should be enforced and implants taken off the market if the studies are not completed as promised.

In summary, the lack of good data, the lack of informed consent, and the lack of unbiased information for women who have become seriously ill from their breast implants are major shortcomings that FDA can help to remedy. We would be glad to share our expertise with you. Please feel free to contact the leaders of our organizations for additional information: Ms. Karuna Jaggar, Dr. Susan Wood, Dr. Diana Zuckerman, Ms. Cynthia Pearson, and Ms. Judy Norsigian.