Another Petition to stop approval of UNSAFE silicone gel breast implants... Tell the FDA Not to Approve Silicone Breast Implants While Mentor is Under a Criminal Investigation

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von Eschenbach, Acting Commissioner

Tell the FDA Not to Approve Silicone Breast Implants

While Mentor is Under a Criminal Investigation

Please write the FDA to tell them that they should

aggressively investigate all allegations made by

Mentor employees and former employees, including

allegations that the rupture rate for Mentor's

silicone gel textured breast implants is higher than

the rate Mentor provided to the FDA, BEFORE the agency

approves Mentor's application. These allegations are

serious and, if true, they show that Mentor's breast

implants may put women's health and safety at risk.

I write to express my support for the investigation of

Mentor Corporation by the FDA’s Office of Criminal

Investigations. The FDA should aggressively

investigate all allegations made by Mentor employees

and former employees, including allegation that the

rupture rate for Mentor’s silicone gel textured breast

implants is higher than the rate Mentor provided to

the FDA. These allegations are serious and, if true,

they show that Mentor’s implants may put women’s

health and safety at risk.

Accurate rupture data are crucial to determine the

safety of Mentor’s silicone gel breast implants. The

FDA Advisory Panel and FDA officials are relying on

these safety data to determine whether Mentor’s

pre-market application (PMA) should be approved.

Rupture and gel bleed have been identified by the FDA

in its Guidance Document for the industry as two of

the essential safety concerns for silicone breast

implants. If the data are inaccurate, whether by

error or due to intentional manipulation, then

Mentor’s entire PMA is suspect. It will be impossible

to assess whether Mentor’s products meet the statutory

requirement to provide a reasonable assurance of

safety with flawed data regardless of whether the

evidence is sufficient to support criminal charges

against the company.

Therefore, we urge the FDA to not approve Mentor’s

silicone breast implants before the agency has

completed and fully reported on its investigation. A

scientific investigation of Mentor’s rupture data may

be needed to supplement the criminal investigation.

In addition, it is crucial that any information

casting doubt on the veracity of Mentor’s data be

shared with the review scientists at the Center for

Device and Radiological Health and be made public.

The public needs to be reassured that the FDA is

fulfilling it obligation to protect consumers by

thoroughly investigating these very serious

allegations.