Two weeks ago, the U.S. Food and Drug Administration convened an expert advisory panel to review and make recommendations on two silicone breast implants (search) manufacturers’ applications to market two different silicone breast implants.<?xml:namespace prefix = o ns = “urn:schemas-microsoft-com:office:office” />
The FDA advisory panel, whose recommendations aren’t binding on the agency’s decision-making process, voted 5-4 that manufacturer Inamed’s application was “not approvable”—not because Inamed’s silicone breast implants weren’t safe but because the data submitted by Inamed had limitations, including what the panel referred to as “inadequate performance” with respect to the rate of rupture of one model.
The panel then voted 7-2 that manufacturer Mentor’s application was “approvable with conditions,” including that plastic surgeons undergo a special training program, patients receive an education and informed consent materials, that a patient registry be established and that data on the devices continue to be collected.
The FDA panel’s votes on the applications, however, don’t come anywhere close to reflecting what the silicone breast implants controversy is really about.
Since the 1980s, personal injury lawyers have used meritless class action lawsuits to bludgeon silicone breast implants manufacturers and extract billions of dollars in settlements, resulting in about a billion dollars in fees for lawyers themselves. It’s been quite a travesty of justice since there’s no credible science to support the vast majority of the claims against the manufacturers.
As I have written previously in this column, numerous studies of silicone breast implants have failed to demonstrate any health risk other than what may reasonably be expected from the surgical implantation of a medical device. Silicone breast implants have not been linked with breast cancer or the variety of connective tissue diseases—such as lupus and rheumatoid arthritis—that have been alleged in the lawsuits.
Despite the absence of science indicating that silicone breast implants cause the alleged harms, the trial lawyers were greatly aided by a bungling FDA that decided very publicly in 1992 to restrict silicone breast implants availability to <?xml:namespace prefix = st1 ns = “urn:schemas-microsoft-com:office:smarttags” />U.S. women who elected to have reconstructive surgery follow mastectomy. Silicone breast implants have continued to be available without restriction to women in other countries.
The media compounded the FDA goof by reporting the agency action as a scary “ban”—and the lawyers were off to the races. Manufacturers were hit with thousands of lawsuits, eventually deciding to settle class action claims as a matter of business and not because there was a factual basis for genuine liability.
Certainly some women did have valid claims arising from typical surgical complications and expected but occasional device defects, but these claims represented only a small minority of the claimants.
Personal injury lawyers, who have worked through groups like NOW and the notorious Command Trust Network, dread FDA approval of silicone breast implants since it would go a long way toward ensuring that the silicone breast implants controversy goes down in history as little more than a trial lawyer stick-up.
To avoid that, groups like NOW sponsor witnesses at FDA meetings to allege that silicone breast implants harmed them. Anti-silicone breast implant activists also have a well-networked presence on Capitol Hill, where they lobby politicians to pressure FDA officials not to approve silicone breast implants. These tactics have worked in the past.
In October 2003, an FDA expert panel acted to approve Inamed’s silicone breast implants application, but in January 2004, harried FDA officials decided to require Inamed to develop and submit more data before final approval could be made.
The data were subsequently developed and resubmitted in August 2004 in preparation for the recent panel hearing.
With another FDA decision looming, NOW and its cronies curiously aren’t attacking silicone breast implants safety so much as they are attacking the FDA and the advisory panel process, alleging that FDA is biased, that insufficient data were considered by the FDA panel and challenging the panel’s composition.
The activists even allege that scientific experts weren’t invited to present data at the advisory panel—a bizarre allegation given that the FDA publicly announced that the panel would be convened and invited any and all experts to testify, which they did.
The activists seemingly will say and do anything to stop silicone breast implant approval, even if it’s the opposite of reality.
Silicone breast implants have been endlessly studied. Scientists and physicians know their track record. An expert panel has green-lighted their use. Failing to raise sufficient concerns about silicone breast implants safety, the activists have set their sights on the politically vulnerable FDA.
Let’s hope for the sake of women who want to choose silicone breast implants—and for the rest of us who would like to see the silicone breast implants scare industry get the official black-eye it deserves—that the FDA staff has the courage this time to accept the advice of its experts and approve silicone breast implants.