Dozens of women who testified at a meeting of the agency’s General and Plastic Surgery Devices Advisory Committee last year pressed for the panel to recommend more long-term research and to support an expanded informed consent process that would give women a better understanding of the benefits and risks before they choose to have the implants. These women told compelling stories of broken health, loss of jobs and effects on families.

Many of the women called for a ban on textured implants that have been linked to the cancer anaplastic large cell lymphoma or ALCL. Health authorities around the word, as well as the FDA, link this form of cancer to some implants. Researchers said there is some evidence the problem with these implants could be bacterial infections.

Thousands of women have complained about autoimmune and connective-tissue disease caused by implants. The FDA has repeatedly said that the “weight of evidence” does not show implants cause “systemic” illness. Despite the fact that researchers at M.D. Anderson Cancer Center have found that silicone implants are linked to higher rates of autoimmune disorders such as scleroderma and rheumatoid arthritis than found in the general population, the FDA is skeptical and has said the study was flawed. In its’ announcement of the committee meeting the FDA stated “there is not sufficient evidence to show an association between breast implants and rheumatologic or connective tissue disease diagnoses”.

Diana Zuckerman, president of the National Center for Health Research, presented evidence at the hearing from a study her organization conducted involving over 400 women who had their implants removed because they were having health problems. In the vast majority of cases the women’s health improved. Zuckerman said in an interview,” We have always said we don’t know what the percentage is – just that for women who are sick, getting them out makes them better.”

The FDA has chosen not to ban the textured implants linked to the cancer anaplastic large cell lymphoma (ALCL). The agency does not believe the product meets the legal standard for being banned at this time.

“Every manufacturer of approved silicone breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their pre-market clinical trials were not designed to answer.” These are words taken from the FDA’s announcement regarding warnings issued to two manufacturers for their failure to follow these requirements. The agency has said further “poor compliance and changes in surgical practice over time have produced results difficult to interpret in a generalized manner much less with the precision needed to deliver personalized patient care.” This seems to indicate the information gathered in conducting the mandatory studies over the years has not been beneficial to patients.

On October 24, 2019, in response to the thousands of complaints, the FDA issued the Draft Guidance for Industry and Food and Drug Administration Staff. It contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. When finalized, the FDA recommends that patient labeling for breast implants include a patient information booklet/brochure, patient decision checklist, boxed warning and a patient device card.

Be aware that, even when finalized, these will only be recommendations. The document is clearly labeled as containing “nonbinding recommendations”. It does not establish any legally enforceable responsibilities. The word “should” in Agency guidance means that something is suggested or recommended, but not required. As of this writing there has been no announcement of the draft being finalized.

We end with the question with which we began.

Is the FDA still failing to warn patients of breast implant risks?

REFERENCES

MD Anderson Cancer Center https://www.mdanderson.org/newsroom/

FDA http://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants

Washington Post, Laurie McGinley https://www.washingtonpost.com/people/laurie.mcginley/