April 11, 2005 - The FDA is beginning a review that could see controversial silicone breast implants return to the U.S. market. Today an FDA panel heard oral presentations from the public.
The implants were banned 13 years ago except for a limited number of women participating in clinical trials. Now, two makers of the implants - Inamed and Mentor -- are trying to show the FDA that the implants have been redesigned and carry minimal health risks for women. The companies will speak before the panel on Tuesday.
But ahead of the three-day hearing, agency reviewers questioned whether the companies have enough data to show that the silicone gel-filled implants are safe in the long term.
An FDA advisory panel voted 9 to 6 in 2003 to recommend that Inamed be allowed to sell its silicone gel implants to U.S. women. An earlier version of the implants was banned in 1992 amid fears that they were prone to rupture and leakage that may lead to health problems.
But the agency went against its advisers and rejected the application, citing concerns that the company had shown that the implants can remain durable for more than a couple of years.
Concerns About Ruptures
Inamed's implants rupture in up to 21% of patients within three to four years, depending on the type of surgery used to place them, according to data submitted by the company in advance of this week's review. The implants ruptured in 3.4% of women who used them for cosmetic breast augmentation, the most common reason for surgery.
Mentor reported that its implants rupture in up to 5% of women within two to three years of surgery and in 0.5% of women who have breast augmentation.
Ruptures can lead to pain and hardness in the breasts and can also damage the appearance of the implants, according to European and American studies.
Silicone gel-filled implants have also been plagued by concerns that they can cause serious systemic health problems like lupus or even cancers. A federal judge in 1999 approved a $3.2 billion legal settlement between one-time manufacturer Dow Corning and thousands of women who claimed to have suffered adverse health consequences from their implants.
In 1999, a report from the Institute of Medicine stated that women with silicone breast implants are no more likely to develop life-threatening illnesses, but it's clear that they can cause serious problems.
Ilena Rosenthal, director of the Humantics Foundation, a group opposed to breast implants, says that "thousands" of women in her organization have serious health problems that they attribute to their breast implants and to silicone. The group is urging the FDA to keep silicone implants off the market for most women.
"These are not recallable items, at least without more surgery to get them out. It's not like taking Vioxx or Bextra off the shelves," Rosenthal says in an interview, referring to the two painkillers recently pulled from the market due to an elevated risk of heart attacks and strokes.
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.
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.