The fundamental questions are:
- Are silicone gel breast implants safe, and
- Have the companies done studies that provide reasonable assurance of safety as required by FDA regulations and guidances? This means long-term data, since women could have implants in their bodies for 10 to 30 years. Data on long-term breakage rates are therefore essential.
Why, 13 years after the moratorium on silicone gel implants imposed by the FDA and the agency’s simultaneous request for the long-term data, have the companies failed to provide at least 10 years of data? In fact, they have not even provided five years of reliable data. This industry failure represents a combination of disrespect and reckless disregard for the health of women and arrogance toward the law.
In December 2003, Mark McClellan, President Bush’s first FDA commissioner, reviewed this issue and rejected approval, ruling that Inamed had not demonstrated reasonable assurance of safety because of the lack of long-term data.
McClellan’s FDA then issued a guidance for the companies, consisting of a roadmap of what companies needed to demonstrate safety. The centerpiece was the need for long-term data. Yet in the spring of 2004, only months after the guidance had been issued and before a significant amount of the FDA-requested additional data could possibly be gathered, both companies submitted new applications. FDA staff reviewed the data and concluded they were deficient because no long-term data on breakage was provided.
Now, as one of his first acts in his new post, Commissioner Crawford has proposed to overturn the decision of his predecessor as well as 13 years of FDA precedent by approving breast implants on the theory that FDA can grant the approval now (even though they lack sufficient data) and get the data later. This turns the statute on its head and is plainly unlawful.
If the agency goes ahead and grants full approval to either the Mentor or the Inamed silicone-gel filled breast implants, we will seriously consider filing a lawsuit to challenge what plainly would be an unlawful, arbitrary and capricious agency action. The dangerous doctrine of “approve now, test later” must be firmly rejected.
BREAST IMPLANT CHRONOLOGY
1988: Public Citizen files a petition to ban silicone gel breast implants based on concerns of many FDA physicians and scientists, incorporated into a large number of internal FDA documents.
1992: FDA moratorium on silicone gel implants (except for women participating in studies) because of a variety of safety concerns. The FDA requested that companies “do core studies … [that] will focus on frequency of implant rupture and leakage, calcium deposits, frequency and severity of capsular contracture, extent of interference with mammography, and frequency of changes in breast or nipple sensation.”
1998: Public Citizen testimony before Instituteof Medicine (IOM)
“[In 1988, we] were concerned about the unrefuted (then or now) problems of rupture, capsular contracture, other serious chest wall problems, including many women in whom silicone gel, from a ruptured implant, had migrated to adjacent organs or formed foreign body granulomas or other debilitating local and regional disease, often quite painful because of extensive inflammation and scar tissue formation.”
1999: IOM Recommendations
“First, reoperations and local and perioperative complications are frequent enough to be a cause for concern and to justify the conclusion that they are the primary safety issue with silicone breast implants (emphasis supplied). Complications may have risks themselves, such as pain, disfigurement and serious infection and they may lead to medical and surgical interventions, such as reoperations, that have risks.
Second, risks accumulate over the lifetime of the implant, but quantitative data on this point are lacking for modern implants and deficient historically. [This was already seven years after the FDA had requested such data.]
Third, information concerning the nature and the relatively high frequency of local complications and reoperations is an essential element of adequate informed consent (emphasis supplied) for women undergoing breast implantation.”