FDA to hold meeting next year to review breast implant safety concerns

^{The FDA will hold a meeting next year to assess the safety of breast implants, following concerns that they are linked to an increased chance of autoimmune diseases occurring in implant patients.} 

The FDA released both press and editorial statements in response to a study conducted by researchers at the MD Anderson Cancer Centre in Texas, which claimed evidence shows that silicone breast implants are linked to an increased risk of certain diseases and conditions, including scleroderma, melanoma and fibromyalgia.

The FDA states that the study’s methodology has “significant shortcomings” and its data includes “inconsistencies” and “potential sources of bias”. More so, the FDA is urging the public to view the study’s conclusion with caution, in fear of it causing more anxiety than necessary.

Silicone-gel breast implants are one of the more stringent devices regulated by the FDA. In 1988, breast implants were reclassified as Class III (high risk) devices following safety concerns and in 1992, the FDA announced a ban on the sale of silicone-gel breast implants. This wasn’t lifted until 2006 when the FDA approved new silicone implants which supposedly met its standards for safety.

Now, silicone-gel breast implants require six post-approval studies to assess long-term clinical performance, something pre-market clinical trials “are not designed to answer”, the FDA states. These post-market studies have resulted in the FDA acquiring data from almost 100,000 patients, a similar number to what is included in the study Texas.

In fact, the study from the MD Cancer Centre includes data from 99,993 patients making it the largest study of breast implant outcomes. The study looks at implants from two manufacturers, Allergan and Mentor, both of which are included in the FDA’s own post-approval studies. And whilst the study does raise concerns over breast implant safety, it also mentions that further analysis is needed with patient-level data if conclusive evidence can be provided.

As it stands, next year the FDA will hold a public meeting with medical experts to review accurate and scientific data relating to the efficacy of breast implants and to promote the issue with the public.

Speaking about the issue, Binita Ashar of the FDA’s Center for Devices and Radiological Health, said: “We understand that there are concerned patients with breast implants who are experiencing a range of symptoms that may or may not be related to their breast implants. We take these concerns seriously and are committed to continuing to work with patient groups, surgeons and scientists to further assess this issue. While the agency continues to believe that the weight of the currently available scientific evidence does not conclusively demonstrate an association between breast implants and connective tissue diseases, we respect studies like the ones published in Annals of Surgery by our peers. These studies contribute to our discourse on this topic, but more evaluation is required.”