Public Citizen’s Health Research Group Regarding Petitions to Block FDA Approval

[Guest guest]

Thanks Ilena,

Statement by Sidney M. Wolfe, MD, Public Citizen’s

Health Research Group 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.”