WASH POST: Mentor caught 'fixing' dangerous implants

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Thanks to Dr. Zuckerman for her work and for sending this article

for us all.

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The Washington Post Mon. 12/5/2005

Implant Maker Fixed Samples Only

By Marc Kaufman

Mentor Corp., which hopes to win Food and Drug Administration

approval soon to sell its silicone-gel breast implants for general

cosmetic use, faced a problem last year as it prepared to distribute

to doctors the demonstration models that prospective customers would

try on for size: The implants sometimes left behind an unsettling

slick of silicone oil.

A former senior engineer with the company told the FDA last month

that he and others were asked to solve that problem and came up with

a less permeable material for the one-inch patch that seals a hole

left by the manufacturing process. But despite urging from its

staff, the company never made the same modification to the devices

destined to be implanted in women who want to have their breasts

restored after surgery or enlarged, the engineer said in a letter to

the agency.

" I am very concerned about the safety of women using these breast

implants if they were to become widely available as an FDA-approved

product, " wrote the engineer, who provided a copy of his letter to

The Washington Post on the condition that he not be identified

because of family and job concerns. He also wrote that he believed

it was misleading to show patients the modified devices but implant

the others.

The former Mentor engineer's allegations are now before the agency

and several congressional oversight committees, adding an new factor

to the long-running debate over wider use of silicone breast

implants.

G. Schultz, director of the FDA's Center for Devices and

Radiological Health, confirmed last week that the agency received

the letter, adding, " We are evaluating it and do take it seriously. "

Possible health complications from silicone-gel " bleeds " are among

the issues the FDA is assessing as it moves toward a decision on two

applications to allow unrestricted sale of silicone implants for

breast enlargement for the first time since 1992. Mentor and Inamed

Corp. received letters from the FDA saying that their devices

are " approvable " if certain conditions are met, and both companies

have undergone final plant inspections by the agency.

Controversy lingers, however, over the safety of the implants.

Several officials inside and outside the FDA -- as well as some

members of Congress, including Rep. L. DeLauro (D-Conn.) --

have urged agency officials to investigate the issues raised by the

Mentor whistle-blower. Wood, who recently resigned as head of

the FDA's Office of Women's Health, said she contacted top officials

in August and was assured the agency would investigate.

Schultz said the FDA's device center has spent more time reviewing

breast implants than any other product during his 11 years as a

manager there. If the devices are approved for wider use, he

said, " all the good, bad and indifferent " information on issues such

as gel bleeds will be fully disclosed so women can make informed

decisions.

Earlier, FDA spokeswoman Zawisza said the agency had received

sufficient gel-bleed data from Mentor and was not concerned about

the issues being raised. She also said the agency would not object

if Mentor used a different demonstration model for sizing as long as

the practice was " not misleading. "

One member of an FDA advisory panel that reviewed the Mentor and

Inamed applications in April said she was disturbed to learn that

women were trying out a modified Mentor device without knowing that

the actual implant might be different. New York dermatologist Amy

Newberger, who opposed both applications, said of the Mentor

engineer's allegations: " On the face of it, that causes me real

concern. "

In a statement, Mentor, which is based in Santa Barbara, Calif.,

dismissed the issue, saying the FDA letter regarding approvability

was based on safety and efficacy data that considered all aspects of

the device, including the patch. That data, the statement said,

showed that gel leakage was " more than a million fold below

toxicological levels of concern. "

The Mentor statement did not address the charge that women were

choosing size with an implant different than the one they would

receive, but it said " new technology development is an ongoing

process at Mentor for all of our products. "

More than 264,000 breast implant surgeries were performed last year

for cosmetic reasons, according to the American Society of Plastic

Surgeons. An additional 63,000 were done for women who had

mastectomies. Since the 1992 FDA decision to restrict silicone-gel

implants because of health concerns, the devices have been available

only to mastectomy patients and women willing to participate in a

clinical trial. Most women seeking breast enlargement have had to

use saline-filled models, which many say produce a less natural

result.

The former senior engineer left Mentor this past spring for another

company. In his letter to the FDA, he said that after it became

known that he was raising concerns about the Mentor implants, the

company made accusations against him that resulted in an indictment

involving disputed company property.

In the letter, the engineer said he assumed that Mentor " will use

those accusations as their defense against the statements I have

made in this letter. " He said he had been advised not to discuss the

accusations, but " fortunately, the statements I have made in this

letter can all be checked out by the FDA. "

The issue of silicone-gel bleed or diffusion is sensitive because

small amounts of silicone oil are known to seep out of all implants.

Improvements to the shells, or outer envelopes, have significantly

reduced leakage since the devices were taken out of general use,

however, and studies have shown that most silicone that leaks out

remains in the cavity created by scar tissue around the implant.

Nonetheless, the issue remains scientifically contentious and

emotionally raw. Although studies generally show that silicone in

the body does not cause ill effects, some women have reported

disturbing consequences. Several told the FDA advisory panel that

silicone oil had seeped out of their foreheads, eyes and elsewhere.

During the panel's hearings, the FDA reported that Mentor's patch

is not made of the same low-bleed material as the rest of the shell.

Inamed's competing device has a low-bleed shell and patch.

The former Mentor engineer first took his concerns to a women's

health advocate, Zuckerman of the Washington-based National

Research Center for Women & Families, who has been critical of the

lack of long-term safety studies of breast implants. She helped him

contact the FDA to talk about his experiences at Mentor.

" If it is true that the patch is low bleed for 'sizers' and high

bleed for the real implants, it suggests that the company cares more

about silicone oil leaking onto doctors' desks than in patients'

bodies, " Zuckerman said. She said new research into low but constant

exposure to chemicals such as silicone suggests that most women will

tolerate it but some will have long-term health problems.

In his letter, the engineer wrote that he and former colleagues had

created an effective and inexpensive low-bleed patch for the implant

samples. He also said that although low-bleed patches cost " a few

pennies extra for each implant, " the company decided not to modify

the implants sold to women. He speculated that the company did not

want to jeopardize its application by having to test a modified

patch.

Mentor officials declined to comment on the engineer's specific

charges. But the company's Web site advises women that there is no

reason to worry about the " the myth of bleed. "

" Minute amounts of 'bleed' occur in all breast implants, " the Web

site says. " It is important to note that all Mentor gel implants are

low bleed. World-wide studies on the subject of bleed have not

linked it to illness in patients. "

During the April advisory panel hearing, an FDA staff report

described three tests the company had undertaken to measure gel

bleed. The reviewer concluded that all were of limited value in

determining what might happen in the body. The gel bleed issue -- as

well as the issue of Mentor's patch -- was barely discussed by the

expert panel, which ultimately recommended that the FDA approve

Mentor's product but not Inamed's.

FDA spokeswoman Zawisza said: " Although Mentor's gel bleed testing

was incomplete at the time of the April panel meeting, Mentor

subsequently addressed the outstanding issues. " She did not provide

further details.

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www.BreastImplantAwareness.org