Silicone Breast Implant Health Risks to be Subject of FDA Hearings
Federal regulators indicate that an advisory committee hearing will be held sometime next year, to address the growing concerns over about health risks linked to silicone breast implants.
On September 14, Dr. Binita Ashar, of the FDA’s Center for Devices and Radiological Health, issued a statement to reassure the public that the agency was looking into recent reports regarding breast implant health problems, and announced that the agency will hold meetings next year so that independent experts can weigh in on the topic.
The statement came in response to a study published last week in the medical journal Annals of Surgery, which warned that side effects of silicone gel breast implants have been linked to an increased risk of rheumatoid arthritis, stillbirth, melanoma and other health problems.
Ashar published an editorial response to the study, raising questions about the findings.
“We commend the work of our peers in studying the benefits and risks of breast implants,” Ashar wrote. “However, we respectfully disagree with the authors conclusions. In our editorial response, we note our concerns with significant shortcomings with the study’s methodology and how the data is presented and concluded, including inconsistencies in the data and potential sources of bias.”
Ashar noted that the FDA’s multi-disciplinary breast implant team met with patient advocates to discuss breast implant related issues. The team intends to hold a public meeting of the General and Plastic Surgery Devices Panel in 2019, which will involve a committee of advisers from the medical community, academia, industry and patient representatives. The recommendations of the FDA’s advisory committees are not binding, but usually have a significant impact on the agency’s final rules and actions.
Breast Implant Concerns
The meeting announcement comes amid increasing concerns about problems with silicone breast implants reported by women nationwide.
Women experiencing a variety of complications often referred to as “breast implant illness” describe chronic side effects, such as fatigue, cognitive problems, muscle and joint pain, hair loss, infections, gastrointestinal problems, rashes and thyroid issues. In many cases, the problems have led women to have their breast implants removed, and concerns about the risk have become a factor many are questioning when deciding whether to undergo breast enhancement or reconstruction surgery.
While the FDA and the medical community acknowledge the risk of breast implant ruptures and leaks, and, more recently, a form of lymphoma found to develop in the tissue surrounding breast implants, the larger breast implant syndrome risk has not yet been recognized.
Most doctors still do not review the potential risk of breast implant health risks with patients, since it is not widely recognized in the medical community and there have been no studies to establish that the problems are caused by the silicone gel implants. However, science often takes time to catch up with the fast pace of emerging health risks that may appear on the internet and social media.
Over the last year or two, the FDA’s focus regarding breast implants that may be linked to a rare form of cancer.
The FDA issued warnings about breast implant lymphoma rates in March 2017, long after concerns about the risks first emerged. A number of subsequent studies have confirmed that the cancer risk is real, and suggest that it may be linked specifically to the use of certain textured breast implants with larger surface areas.
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 Surgerywarned that many breast implant cancer cases worldwide have likely not been reported, and noted that many doctors continue to be unaware of the BIA-ALCL risk.
As awareness of the problem increases, many experts have warned that the number of diagnosed breast implant ALCL cancer cases is likely to increase. As a result of manufacturers’ failure to adequately research the risks associated with their devices, a number of women are now pursuing potential breast implant cancer lawsuits, and it is possible that breast implant illness claims may also be pursued if independent scientific evidence emerges to support the claims.
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