Study Questions Safety of Silicone Breast Implants; FDA Disputes Findings

A new study is again raising questions about the safety of silicone breast implants, though the FDA has come out and said it disagrees with its conclusions.

Researchers at MD Anderson Cancer Center in Houston looked at data on about 100,000 women that had received silicone breast implants. The data came from post-marketing studies that the only 2 manufacturers of silicone implants were required to conduct after the devices were approved in 2006.

Results, published in the journal Annals of Surgery, found that women that received breast implants had an increased risk of autoimmune disorders, stillbirth and melanoma compared to women in the general population. Women with the implants had a 6 times higher risk of developing rheumatoid arthritis, a 4.5-fold increase in risk of stillbirth and a 4 times higher risk of melanoma, a skin cancer.

Silicone implants were also associated with a higher risk of surgical complications compared to saline implants.

In an editorial response, Binita S. Ashar, MD, director of the FDA’s Division of Surgical Devices, wrote that the agency disagreed with the study’s conclusions, noting concerns with methodology.

Ashar also announcedthat the FDA will hold a public meeting next year on breast implant safety.

Silicone implants were initially banned in 1992 amid safety concerns. In March, the FDA saidit was “working to update and enhance information” on a potential association between breast implants and a type of lymphoma.


Jonathan Block

Jonathan Block

Jonathan Block is an associate editor at BioCentury, which provides news and information about the biotechnology and pharmaceutical industries. Prior to joining BioCentury in 2019, Jonathan worked for MedShadow as content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.


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