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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.

RYAN DONNELL / SPECIAL TO DMN Austin Templer, who worked for the FDA, called the Mentor inquiry a sham. "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."

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