Mentor criminal investigation

[Guest guest]

The FDA has started a criminal investigation of Mentor

Corporation, regarding their breast implants. Two

stories are below.

Best wishes,

Zuckerman, Ph.D.

President

National Research Center for Women & Families

1701 K Street, NW, Suite 700

Washington, DC 20006

(202) 223-4000

www.center4research.org

FDA Week, January 24, 2006

FDA Criminal Investigation Shop Looks Into Breast

Implant Allegations

FDA's Office of Criminal Investigation is interviewing

people about the rupture data that Mentor submitted to

FDA on its textured silicone breast implants, sources

say. One of at least two interviewees include a former

Mentor employee who last year alleged the company hid

rupture data from the agency.

It is unclear if the OCI is on a fact finding mission

or pursuing a formal investigation. An FDA

spokesperson would neither confirm nor deny an

investigation is underway.

Sources say an OCI investigator asked those

interviewed about rupture data that Mentor gave FDA as

part of a multi-product approval package. The

investigator also asked general questions about the

company's practices, the sources say.

The former Mentor employee spoke with OCI Dec. 19 in

FDA's Dallas

office.

A Mentor spokesperson says the company has given FDA

all rupture

complaints from product evaluations, warranties,

clinical study

departments or any other source. Mentor has told FDA

Week in the past that it remains confident that its

product will be approved, and points out in a company

statement that the former employee was indicted by a

Texas district attorney for stealing Mentor implants

and selling them on eBay.

In a letter to FDA last November, the former Mentor

employee alleged that Mentor hid rupture data from

FDA.

" The textured silicone gel breast implants made by

Mentor have a design flaw that results in a higher

rupture rate than [the company's] smooth shell

implants, " the former employee wrote. " That higher

rupture rate has not been accurately reported to the

FDA. "

The former employee told OCI investigators of hearing

conversations while at Mentor that warranty claims for

the textured implant were much higher than the number

of defects doctors reported, the former employee tells

FDA Week. The former employee also reports telling OCI

that the company may have categorized leaks under

other defects like joint failures or patch failures.

The former employee worked in Mentor's research and

development

department and stresses to FDA Week that this division

is not privy to product quality data. The former

employee told OCI of hearing that the company hid data

from another employee who transferred from product

evaluation to research and development, the former

employee says.

The OCI investigator may interview this employee,

sources say.

Textured implants are made with two layers of silicone

to prevent the prosthesis from moving around, the

former employee explains to FDA Week. Over time, the

rubbing between the two layers can result in tiny

fractures and lead to ruptures.

The texturing process is used to make some saline

implants as well, which Mentor already has on the

market.

The former employee also alleged in the letter to FDA

that Mentor may have misled patients by supplying

doctors with sample implants that use a low-bleed

patch that leaks less than those used in surgery (see

FDA Week, Dec. 16). Previously, FDA Week reported that

FDA thinks the company likely did nothing wrong by

giving doctors a demonstration implant that is

different from the one used in surgery unless Mentor

purposely misled patients.

Sources close to the investigation say the

demonstration models do not appear to be the focus of

the OCI investigation.

Drug lawyers say it is unusual for the OCI to

investigate a company that is not involved in product

diversion or counterfeiting.

" It's significance is that they've decided that [the

accusations] are serious enough to dedicate resources

to, " one drug lawyer said.

Another drug lawyer points out that the Department of

Justice does not have to approve cases that OCI

brings. Instead, OCI can bring the case directly to a

U.S. Attorney General, which bypasses some

bureaucracy, the lawyer says.

Breast implants are also the subject of a Senate

health committee

investigation.

Last year, Sen. Mike Enzi's (R-WY) committee started

looking into

financial conflicts on the FDA advisory committee that

recommended Mentor's implants be approved for general

use. A committee spokesperson says the panel is also

taking into account the former employee's accusations.

Other legislators also have talked to the former

employee, sources say.

Silicone implants currently are only available to

women who need them for reconstructive surgery, but

they have been widely used nonetheless. Opponents of

the product say even small silicone leaks caused by

cracks or ruptures could be harmful to women.

Mentor wants to put its silicone implants on the

market for general use. The company last summer

received an " approvable " letter from FDA for marketing

the product. FDA stated it would approve the device if

the company meets certain conditions. FDA and Mentor

are not allowed to talk about these

conditions.--Catharine Richert

------------------------------------------

WASHINGTON, Jan 25 (Reuters) - A consumer activist and

a former Mentor Corp. (MNT.N: Quote, Profile,

Research) employee said on Wednesday they had been

interviewed by U.S. criminal investigators about the

company's experimental silicone breast implants.

Zuckerman, president of the National Research

Center for Women & Families, told Reuters she spoke

last Friday with investigators from the Food and Drug

Administration's (FDA) Office of Criminal

Investigations.

Zuckerman, who has questioned the long-term safety of

silicone implants, said she was asked in part to

recount allegations from former or current Mentor

employees who had told her the company failed to

accurately report the difference in rupture rates

between smooth and textured implants.

Mentor said in a statement: " We have not been notified

by the FDA of an investigation regarding that issue. "

A former Mentor employee also said in an interview he

was questioned by an FDA criminal investigator in

December. He spoke to Reuters on condition of

anonymity.

FDA spokeswoman Bro said she could not confirm

or deny whether the FDA had launched a criminal probe

of Mentor.

Mentor and rival Inamed Corp. (IMDC.O: Quote, Profile,

Research) are seeking FDA approval for silicone breast

implants. The FDA has told both companies it would

approve the implants for sale if certain conditions

are met. The conditions have not been disclosed.

Zuckerman said FDA investigators asked her about

allegations from three former and one current Mentor

employee who had contacted her.

The investigators asked in part about charges that

Mentor did not report rupture rates for the implants

accurately.

" That's one thing I know interested (the

investigators), the idea that the rupture rate is

higher than has been reported, " Zuckerman said.

Zuckerman said she had no way of knowing whether any

of the allegations were true.

Mentor said the company had reported all rupture

complaints to the FDA and that its Texas manufacturing

facility had been audited annually by the FDA and

international regulators since 1999.

" This FDA audit included a review of the complaint

reporting process and no issues with that process were

identified, " the company said.

The former Mentor employee, an engineer who said he

was interviewed in December, said he also spoke at the

same time with two officers from the FDA's Office of

Compliance, which makes sure companies follow device

regulations.

The former employee said he was questioned about his

charges that Mentor used a " low-bleed " patch for the

implants that women try on externally for size, while

a higher-bleed patch was used in devices put into

women's bodies.

Such patches seal the opening through which the

silicone gel is placed in the implant.

Mentor said in December those allegations were " wrong "

and that the engineer had been indicted for stealing

implants from the company and trying to sell them.

The engineer said he directed the investigators to

others to contact about allegations regarding rupture

rates.

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