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FDA Intensified Breast Implant Warning

This Wednesday, the US Food and Drug Administration (FDA) recommended intensified warnings for certain types of breast implants due to new information about risks associated with the products. 

Earlier this year, we discussed the recall of the Biocell breast implants. The implants were found to be associated with a disproportionate number of lymphoma cases, specifically anaplastic large cell lymphoma–a type of cancer that affects the immune system. The lymphoma occurs in the scar tissue (fibrous capsule) that surrounds the implant and in more advanced cases, may spread to lymph nodes near the breast. The cancer typically progresses slowly and can usually be treated by surgically removing the breast implant and/or the associated scar tissue. However, in rare cases when cancer spreads to the lymph nodes in other parts of the body, it may be fatal.

The recall was one step in a larger, ongoing effort to deal with the implants and their effects. Issues with the implants were first highlighted during a series of FDA hearings in March, during which doctors and patients presented data about the women who were diagnosed with cancer, while manufacturers presented their findings, which generally indicated that the only patients at risk would be those whose implants were six years old or older. 

Eventually, one manufacturer, Allergan, agreed to a global recall of its Biocell textured breast implants. However, many women have contacted the FDA, reporting that women who are considering implants are not being adequately warned about the potential long-term risks that they might be facing. 

The FDA’s principal deputy commissioner stated this week that the federal agency had “heard loud and clear from the public advisory panel meeting” that more must be done to protect women. Now the FDA is recommending that manufacturers identify risks in the boxed warning, including that:

  • breast implants are not lifetime devices
  • the chances of developing complications increase the longer a patient has the implant, and additional surgery may be required to address the complications
  • breast implants have been associated with the risk of developing the rare cancer and may be associated with the systemic symptoms

Dr. Oren Lerman,  director of Lenox Hill Hospital’s Aesthetic and Reconstructive Breast Surgery Fellowship, thinks that increasing the warning on implant labels is a good first step, but stressed that it cannot be the only method of conveying information to potential recipients. She stressed the need for a full and informed discussion between the patient and her surgeon. The FDA is working on implementing guidelines that will facilitate such discussions and has proposed that manufacturers include a checklist for patients to discuss with their surgeons weighing the risks and benefits of the implants.

The cancer risk is especially troubling, given the fact that of the hundreds of thousands of women in the United States who get breast implants each year, about 25% do so after having a cancer-related partial or total mastectomy, and research has demonstrated that cancer survivors, in general, have an increased chance of developing cancer compared to people of the same age and gender who have not had cancer.

About the Author

Briggs Bedigian
Briggs Bedigian

H. Briggs Bedigian (“Briggs”) is a founding partner of Gilman & Bedigian, LLC.  Prior to forming Gilman & Bedigian, LLC, Briggs was a partner at Wais, Vogelstein and Bedigian, LLC, where he was the head of the firm’s litigation practice.  Briggs’ legal practice is focused on representing clients involved in medical malpractice and catastrophic personal injury cases. 


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