Public Citizen Calls for Criminal Investigation of Breast Implant Manufacturer for Withholding Safety Data from FDA

http://www.citizen.org/pressroom/release.cfm?ID=2289



Oct. 12, 2006

Public Citizen Calls for Criminal Investigation of Breast Implant
Manufacturer for Withholding Safety Data from FDA

Company Studies Showed Dangers Associated With Silicone Gel Implants

WASHINGTON, D.C. – Public Citizen today called for a criminal
investigation into Mentor Corporation’s apparent failure to send the
Food and Drug Administration (FDA) data showing safety problems with
their silicone gel implants. The consumer advocacy organization also
called on the FDA to wait until it has reviewed all available safety
data before deciding whether to approve the implants.

On June 22, a former scientist from Mentor – one of the two companies
seeking FDA approval of silicone gel breast implants – sent a letter
to the FDA accusing the company of withholding from the FDA a variety
of important new safety information. Prior to sending the letter, the
scientist had raised all of the serious concerns documented in the
letter within the company, urging Mentor to submit the data, but it
refused and fired the scientist.

An FDA staffer who received the letter told the former Mentor
scientist that since the withheld test data were not required in FDA’s
request to Mentor for more studies, and since the submitted data from
both Mentor and Inamed (another silicone gel breast implant
manufacturer) were similar, he had no other comment on the new
information, implying that the agency would take no action.

“Unless the FDA opens a criminal investigation into Mentor’s failure
to submit the studies, it will only encourage Mentor and other device
manufacturers to selectively send the agency only those studies that
put their products in the most favorable light,” said Dr. Sidney
Wolfe, director of Public Citizen’s Health Research Group, who today
sent a letter to the FDA calling for an investigation. Public
Citizen’s letter and the former Mentor scientist’s letter are
available here.

The former Mentor scientist told the FDA that data about the diffusion
of chemicals from the implant into the body were invalid and had been
fraudulently represented. Other data he referred to understated the
magnitude of weakening of the implant shell after implantation, which
is relevant to its rupture. Still other data showed that as the
distance from the front of the implant to the back increased, the
estimated lifetime of the device decreased.

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www.BreastImplantAwareness.org