Fw: FDA/Mentor Dallas Morning News

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----- Original Message -----

From: " Kathi " <pureheart@...>

Sent: Tuesday, September 03, 2002 9:20 AM

Subject: FDA/Mentor Dallas Morning News

> From:

> " Kim Hoffman " <krhoffman@...>

>

> Resolution elusive 4 years into breast-implant

> inquiry

>

> FDA keeping lid on case involving Irving manufacturer

>

> 09/03/2002

>

> By JIM MORRIS / The Dallas Morning News

>

> WASHINGTON - Four years ago, the Food and Drug Administration began a

> criminal investigation of Mentor Corp., a breast-implant manufacturer

> whose

> factory in Irving had fallen into disfavor with FDA inspectors.

>

> The inquiry, conducted by the FDA's Office of Criminal Investigations,

> remains

> open. But that's about all anyone outside of the agency knows about

> it.

>

> " We would love to get a better indication of what the focus might be, "

> said Josh

> Levine, Mentor's senior vice president for sales and marketing. " We

> have asked

> repeatedly. "

>

> Mentor says that any deficiencies at the plant were minor and long ago

>

> corrected.

>

> Others suspect the problems are more serious. In January 2000,

> Austin

> Templer quit his job as a Dallas-based FDA compliance officer because,

> he

> said, he came to believe that the Mentor investigation was a " sham, "

> intended to

> keep inquisitors at bay.

>

> " The agency has gone

> out of its way to

> ensure that the public

> does not know " about

> potential health

> hazards associated

> with Mentor's

> products, Mr.

> Templer said.

>

> Members of the

> House Energy and

> Commerce Committee

> have been pressing the

> FDA for information,

> to little avail. " I'm

> questioning just how

> 'active' this 'active investigation' is, " said Rep. Roy Blunt, R-Mo.

> Another

> committee member, Rep. Gene Green, D-Houston, said there could be

> hearings

> if answers aren't forthcoming.

>

> What is going on at Mentor's Texas plant, which supplies saline- and

> silicone

> gel-filled implants to women throughout the United States and Canada?

>

> Because the FDA is not talking, implant recipients and would-be

> recipients are

> left to wonder whether the products are safe. And Mentor is left

> operating under

> a cloud, which the company would like lifted before it asks the FDA to

> remove

> restrictions on silicone implants.

>

> The FDA would not discuss the investigation with The Dallas Morning

> News.

> Interviews with Mentor officials, Mr. Templer and others indicate that

> it involves

> the company's manufacturing practices, its handling of an FDA-required

> clinical

> study, or both.

>

> Headquartered in Santa Barbara, Calif., Mentor completed the move of

> its U.S.

> manufacturing operation from Goleta, Calif., to Skyway Circle North in

> Irving in

> the summer of 1994.

>

> In 1995, the FDA began inspecting breast-implant factories to

> determine

> whether they were making sterile, uniform products and keeping records

> of

> patient complaints. (The agency was still smarting from charges that

> it had been

> slow to respond to concerns about silicone implants, which some

> patients and

> physicians had blamed for debilitating illnesses.)

>

> Mentor fared poorly in its inspection, said Mr. Templer, who worked in

> the

> FDA's Dallas district office. " They found a whole lot of problems, " he

> said, and

> a warning letter was issued at his urging. The letter stated that

> Mentor, among

> other things, had not investigated implant failures or patient

> complaints in a timely

> fashion.

>

> Because of the criminal investigation, the FDA will not publicly

> release Mentor

> inspection reports dating to 1995. e Scherff, the company's vice

> president

> for regulatory compliance, said that FDA inspectors made routine

> observations

> about the Irving plant during each of the reviews and that Mentor took

>

> appropriate action.

>

> Mr. Scherff said he was told the plant was in full compliance with FDA

>

> regulations after the most recent inspection in February. Mr. Levine

> said the

> agency had never expressed doubts about the safety of Mentor's

> implants. " If

> there had been any question at all, even a remote question, they would

> have shut

> us down, " he said.

>

> Employee allegations

>

> From 1995 through 1999, however, current and former Mentor employees

> brought Mr. Templer a range of allegations. Saline implants equipped

> with a

> certain type of valve tended to leak, they said, and silicone implants

> may have

> been contaminated with platinum and polyurethane. Some patients'

> complaints

> were not being noted, the informants alleged, and manufacturing

> processes were

> not being properly validated to ensure product uniformity.

>

> " If a company isn't manufacturing a product under a good state of

> control, it's

> going to have a much higher rate of failure, " said Mr. Templer, who

> lives in

> Frisco.

>

> Some of the same informants were talking to Kim Hoffman, who received

> Mentor's Siltex silicone implants in March 1995 and said she began

> suffering

> from extreme fatigue, memory loss and a " burning, itchy feeling " in

> her breasts.

>

> Ms. Hoffman, who lives in Niangua, Mo., had the implants removed after

> eight

> months, and her health, she said, gradually improved. But when she

> tried to

> report her ailments to Mentor so they could be included in a clinical

> study, she

> said, " they treated me like a litigation problem rather than a patient

> and referred

> me to their lead counsel. They just blew me off. "

>

> Ms. Hoffman contacted the FDA and later began talking to current and

> former

> Mentor workers, who told her that her and other women's health

> problems had

> been excluded from the study, upon which the agency depends to monitor

>

> complication rates.

>

> " I was totally alarmed, " Ms. Hoffman said. Her fear, she said, is that

> " bad

> products are getting into the market and there's a breakdown in the

> regulatory

> process that allows them to stay on the market. " She has sued Mentor,

> alleging

> that it knowingly made a defective product and negligently conducted

> the study.

>

> Mr. Scherff said he could not comment on Ms. Hoffman's allegations

> because of

> the lawsuit. He did cite a 1999 FDA inspection report that concluded

> patient

> " complaints received were handled [properly] and the appropriate

> records

> maintained. "

>

> Mentor also has been named in a class-action lawsuit alleging that a

> valve on its

> saline implant, used from 1984 to 1994, regularly failed. The

> company's

> response: " There were no safety concerns with this product. " The

> valve, it said,

> was replaced with an even better device.

>

> Throughout 1996 and 1997, Mr. Templer continued to interview

> informants and

> pushed officials at FDA headquarters to force Mentor into compliance.

> In May

> 1998, the company entered into a consent decree with the agency,

> promising to

> subject itself to examination by outside experts and improve its

> validation

> procedures.

>

> " It was purely a documentation issue, " Mr. Scherff said. Mentor used

> the same

> validation techniques in Texas that it had in California, where the

> district FDA

> office had no objection, he said.

>

> " The Texas FDA officials did not agree that the validations were

> adequate, " Mr.

> Scherff said, but found nothing that suggested an " increased risk to

> women " and

> did not restrict or halt sales.

>

> Dr. Harlan Pollock, a Dallas plastic surgeon, said he had used

> Mentor's

> products for years and had " always found this company to be very

> upfront and

> ethical. I've been very pleased. "

>

> Currently, only saline implants may be used for purely cosmetic breast

>

> augmentation.

>

> After some patients and researchers contended that silicone implants

> were prone

> to leakage and caused disease, the FDA decreed in 1992 that the

> products

> would be available only for breast reconstruction - following cancer

> surgery or

> to fix a congenital deformity or a prior implant problem.

>

> Results of study

>

> While some studies have continued to raise questions about the safety

> of silicone

> gel, others - notably, one published by the Institute of Medicine two

> years ago -

> have found no link between the substance and cancer or other serious

> illnesses.

>

> Mentor officials say they will ask the FDA, possibly next fall, to

> allow silicone

> implants to be sold again for breast augmentation, a larger market

> than

> reconstruction.

>

> Mr. Levine, of Mentor, said the company's implants are " unequivocally "

> safe.

> But Ms. Hoffman and Mr. Templer, who began sharing information in

> 1998,

> said problems at the plant went beyond the paperwork issues that

> company

> officials described.

>

> According to a memorandum written by Mr. Templer in December 1999, for

>

> example, one former Mentor employee said in an affidavit that she and

> her

> supervisor had been fired " after they prepared a series of reports

> regarding very

> high field failure rates in Siltex breast implants. " She also alleged

> that Mentor

> destroyed records that reflected negatively on its products.

>

> Mentor sued the woman for defamation after she made the allegations in

> an

> unpublished letter to Forbes magazine in 1997. In the suit, which was

> dismissed

> under confidential terms, the company denied the charges and said the

> woman

> had been fired for " deficient job performance " and violating company

> policies.

> Neither Mentor nor the woman would comment.

>

> Mr. Templer and Ms. Hoffman were instrumental in getting the FDA to

> open a

> criminal inquiry of Mentor in the summer of 1998. But by the end of

> 1999, Mr.

> Templer had become suspicious and disheartened. He soon resigned.

>

> Dr. Suzanne Parisian, former chief medical officer in the FDA's Center

> for

> Devices and Radiological Health, said the agency had been reluctant to

> take

> harsh actions against breast-implant manufacturers.

>

> " A whole culture has grown up dependent on these devices, " said Dr.

> Parisian,

> now a consultant in Front Royal, Va. " The FDA is caught between a rock

> and a

> hard place. "

>

> E-mail jmorris@...

>

>

>