The Food and Drug Administration announced this week that it’s analysis of silicone-gel breast implants did not reveal any unknown safety concerns. The conclusions were drawn in large part from studies done by the implants’ manufacturers, Allergan Inc. and Johnson & Johnson’s Mentor Worldwide unit. The FDA will allow the implants to remain on the market.
Women receiving silicone-gel breast implants have frequent complications such as scarring or hardening breasts, and 20% or more of patients required implant removal within 10 years, the Food and Drug Administration said. Silicone breast implants were allowed back onto the U.S. market for cosmetic purposes in 2006, following an extensive ban on their use by the FDA in 1992 because of safety concerns.
During the 1990s, litigation by thousands of women alleged that systemic illnesses including lupus, rheumatoid arthritis and scleroderma had been caused by silicone seeping through the body. While those contentions led to multibillion-dollar settlements with Dow Corning Corp. and other manufacturers, the FDA argues that the allegations were never proved.
According to the data released by the FDA, 20% to 40% of women receiving implants for augmentation required a reoperation in the first eight to 10 years after getting the implants. The figure was 40% to 70% for women who had implants for reconstruction, including after cancer surgery.
The FDA said one of the most common side effects was a hardening of the breast around the implant. Other side effects include rupture and gradual seeping out of silicone as well as scarring, pain and infection.
But the FDA found that despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make well informed decisions about their use. The FDA advises that it is imperative for women with implants to get routine medical images to screen for implant ruptures and other complications. Women should notify doctors if they experience pain, swelling or other changes.
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