It seems that the FDA is considering again to lift restrictions on silicone breast implant sales in the US. According to the New York Times, “… in documents made public on Wednesday, health regulators estimated that up to 93 percent of silicone breast implants ruptured within 10 years.” The decision is expected by April 13. With statistics like that, one wonders whether positive decision for sales is possible.
The crucial issues are how often the implants break, what happens to the silicone when they rupture and what health effects result. In the late 1980’s and early 90’s, thousands of women said ruptured implants had caused myriad connective-tissue and autoimmune diseases that included multiple sclerosis. The assertions bankrupted Dow Corning, a large maker of implants.
An expert committee of scientists found in 1999 that there was little evidence that silicone implants caused such diseases. Instead, the primary safety concern, the panel found, was the tendency of silicone implants to cause local complications like infections, pain and scarring.
More at NYT…