FDA Reviews Ban on Silicone Breast Implants
2 Companies Want Silicone Gel-Filled Implants Back on U.S. Market
Concerns About Ruptures continued...
A 2003 Danish study of 238 women showed that those with ruptured implants -- in which liquid leaked beyond tissue immediately around the implant -- were three times as likely to report connective tissue disease such as rheumatoid arthritis and fibromyalgia. They were also twice as likely to complain of fatigue as women whose implants remained intact.
Other studies have suggested that the silicone gel-filled implants can interfere with mammography screenings, making it more likely that breast cancer goes undiagnosed.
FDA scientists cautioned that the study did not look at women using Mentor or Inamed implants.
Both companies say they plan to set up detailed patient registries to follow the health of patients in the years after their surgeries.
FDA reviewers expressed concern that the data submitted by the companies looked only at a relatively small number of women and could not closely estimate all of the potential health effects of ruptures.
They also said it remains impossible to tell how many of the implants could rupture 10 or more years following surgery. Some theoretical estimates put the number between 21% and 74%.
"It is difficult to reasonably predict the probability of rupture through year 10," FDA officers wrote in their review.
The committee is expected to cast votes on the two companies' products Wednesday.