Breast Implant Benefits And Risks To Be Topic Of Upcoming FDA Public Hearing

A panel of experts will meet in March to discuss the benefits and risks associated with breast implants, amid growing concerns over a rare type of lymphoma that may develop in the tissue surrounding certain models. 

The FDA recently announced on its breast implants web page that it will convene a meeting of its General and Plastic Surgery Devices Panel on March 25 and 26. The panel is made up of advisors to the agency, who will make recommendations on future policy.

FDA Commissioner Scott Gottlieb tweeted about the upcoming public meeting on January 28, saying it will cover a range of topics.

“The meeting seeks public input on benefit/risk considerations and possible measures to further address certain risks with breast implants to help ensure the public continues to have accurate, scientifically-sound information about the benefits and risks of breast implants,” Gottlieb wrote. “We encourage members of the public to provide comments to the panel and FDA on this topic.”

The agency’s website indicates that the FDA plans to publish a Federal Register notice and agenda on its Advisory Committee Calendar web page 15 days in advance of the meeting.

While neither Gottlieb nor the announcement mentions a specific topic, the meeting comes as concerns grow over a rare form of cancer known as breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), which has been linked to large surface-area, textured breast implants in a number of studies and reports worldwide.

The advisory committees’ recommendations are not binding, but the FDA usually weighs its committees’ findings heavily when considering new regulations and guidance.

Breast Implant Cancer Concerns

On January 26, 2011, the FDA first released a report about case studies and epidemiological research that suggested there was a link between breast implants and ALCL.

The agency then issued a statement about emerging information on the breast implant lymphoma problems last year, and a number of subsequent studies have confirmed that the breast implant ALCL cancer risk is real.

In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.

In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.

In March 2018, the FDA indicated that it was aware of more than 400 cases of breast implant-related cancer. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.

As regulators and researchers worldwide continue to evaluate the specific cause of the breast implant lymphoma problems, other women are also raising serious questions about why certain products appear to be more likely to be associated with the development of cancer, and how manufacturers failed to address potential design defects earlier.

Product liability lawyers in the U.S. are now reviewing other potential breast implant cancer lawsuits for women diagnosed with ALCL in recent years, alleging that manufacturers knew or should have known about the risk, yet withheld warnings from consumers and the medical community.