| Ilena Rose 2005-09-28, 9:42 am |
| Statement of Sidney Wolfe, MD, Regarding Petitions to Block FDA
Approval of Silicone Gel Breast Implants (HRG Publication #1747)
http://www.citizen.org/publications/release.cfm?ID=7397
August 9, 2005
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.”
|