Fwd: Could you run this artical in the Durham Sun

[Guest guest]

Please Post: WE CAN'T ALLOW TO BE FORGOTTEN.

Ladies please send this (in this type format) or any way you'd like to word it, as I did, to your local news papers. Look them up on the net, find their email address and forward this artical to them. I JUST SENT MINE!

Silicone Suckered

We Implant Victims seem to be forgotten in most Cities. While all the Sept. 11th and Investment news, seems to be taking center stage.....Implant makers and Plastic Surgeons are still making big money off women, all the while, knowing, we (the one's that have walked this road)are getting worse.

Subj: Dow working on a settlement, while thousands of women are still sick and getting worse.

Implants in the Dallas Morning News!

Date: 7/21/2002 10:45:58 PM Central Daylight Time

From: dz@...

MAM-NSIF@...

Sent from the Internet (Details)

We thought you'd be interested in today's Dallas Morning News. Some of you may want to send letters to the editor, just to express your support for their writing such a balanced article.

See below.

Best wishes,

Zuckerman, Ph.D.

President

National Center for Policy Research (CPR) for Women & Families

1901 Pennsylvania Avenue, NW

Suite 901

Washington, DC 20006

202 223-4000

www.center4policy.org

DallasNews.com | Dallas-Fort Worth | Latest News Last modified: 12:51 AM CDT on Sunday, July 21, 2002

Implants at core of FDA debate

Despite patients' problems, device makers want faster review

07/21/2002

By JIM MORRIS / The Dallas Morning News

WASHINGTON – Amid a growing furor over the Food and Drug Administration's approval of saline breast implants, medical device manufacturers are lobbying Congress – with apparent success – to allow even faster reviews of implants and other products ranging from artificial joints to bio-engineered skin. Some members of Congress have been pressing the FDA to explain why it approved saline implants, the supposedly safe alternative to silicone implants, two years ago despite high complication rates among study participants and a criminal investigation of one of the two manufacturers, Mentor Corp.

At the same time, legislative proposals expected to emerge as a bill this summer would allow device manufacturers to speed through what is now a plodding approval process by paying user fees, which would guarantee them a finite review time and provide resources to the understaffed FDA.

JUAN GARCIA / DMN

Dr. Melmed, a Dallas plastic surgeon, displays three types of breast implants. "I see more problems from them than benefits," he said.

Some companies could be inspected and reviewed by outside parties rather than the FDA, although the agency would have the final say on any product.

Critics argue that information from manufacturers eager to bring products to market cannot be taken at face value, and fear the involvement of third parties would weaken an already spotty review process.

"That's scary, isn't it?" said Eileen Swanson of Haddon Heights, N.J., who blames saline implants for health problems including severe joint and muscle pain and chronic weakness.

More than 200,000 women in the United States have saline implants each year – about 80 percent for breast augmentation and 20 percent for breast reconstruction, according to most estimates. Ms. Swanson and others have not been encouraged by recent revelations about the products.

Little data

At an FDA advisory panel meeting July 9, Mentor stunned panelists and observers by reporting that it had complete data on only 5 percent of the augmentation patients who were to have been included in a five-year study. Rep. Jim Greenwood, R-Pa., is among those wanting answers from the FDA. He co-authored a July 11 letter to the agency seeking information on the investigation of Mentor and "all records relating to the saline breast implant studies" it and the other manufacturer, Inamed, presented at the panel meeting.

Mr. Greenwood also is crafting legislation that would let makers of breast implants and other medical devices – including pacemakers, dialysis equipment and implantable defibrillators – pay user fees in exchange for quicker safety reviews. Such a system has been in place for drug manufacturers since 1992.

Mr. Greenwood did not return calls to his office seeking comment. A like-minded colleague, Rep. Joe Barton, R-Ennis, said that a streamlined, fee-based review system "would bring new medical devices more quickly to market for people who need assistance. It would enhance their quality of life and provide additional revenue to the FDA."

But some public health advocates find the concept troubling. Although the third-party inspectors and reviewers would have to be accredited by the FDA, they would be paid directly by the manufacturers whose products were under consideration.

"What's to stop a company from paying one of these people an amount of money that's clearly intended to increase the inspector's positive feelings toward the company?" asked Dr. Zuckerman, president of the National Center for Policy Research for Women & Families. "There has to be a firewall between the inspector and the company that hires them. This [draft] legislation destroys that firewall by creating a financial relationship between the inspector and the company."

Soaring demand

Medical device manufacturing has become a $71 billion-a-year industry in the United States. As the population has aged, demand has soared for products such as heart valves and artificial hips. AdvaMed, the manufacturers' main trade association, has been lobbying doggedly for a new approval process. It nearly succeeded two months ago, when sympathetic lawmakers attached an amendment to the bioterrorism bill; the amendment failed, primarily because of the third-party issue. Legislative proposals that would pave the way for user fees still enjoy strong support.

Jim Benson, AdvaMed's recently retired executive vice president for technical and regulatory affairs and now a consultant to the group, said that many potentially life-saving products are being kept from the market by slow FDA reviews.

Although the law says that such devices should be reviewed within six months, the average review time now exceeds a year, said Mr. Benson, who was once director of the FDA's Center for Devices and Radiological Health. Like many former officials, he left government to work for the industry he used to regulate.

"When I was at the agency, most of us felt user fees weren't a real good idea, that [reviews and inspections] were a service government should provide," he said. "I finally concluded that, because Congress was never going to give the FDA enough money to really do the job, user fees were the only way to get the FDA on a solid footing."

The thinking is that a manufacturer would pay a certain amount – say, $125,000 for a pre-market approval application – to the FDA in exchange for a predictable review period. The FDA could use the money to hire staff, buy computers or otherwise amplify its resources.

"Our industry is growing," Mr. Benson said. "We are so varied. It's going to take a lot of effort on the part of the agency to keep up with the technology."

Notable failures

There have been notable device failures. The Bjork-Shiley heart valve, for example, was blamed for at least 130 deaths. But Mr. Benson said the vast majority of manufacturers are diligent and the vast majority of their products are sound. "The good that devices have done for public health so far outweighs the problems that they're in different ballparks," he said.

Still, women who have lived the breast implant sagas – first silicone, then saline – say they are skeptical of anything that might give manufacturers more influence, especially in light of Mentor's poor showing at the July 9 FDA advisory panel meeting.

Although rigorous patient follow-up had been made a condition of approval for both Mentor and Inamed in May 2000, Mentor's weak data surprised the panelists. The company said it had complete information on only 60 of 1,221 breast augmentation patients within five years of their surgeries. This made it nearly impossible to gauge the extent of complications.

Inamed, by comparison, had complete information on 686 of 846 augmentation patients, or 81 percent, a follow-up rate deemed acceptable by the FDA.

Dr. al, director of the agency's Center for Devices and Radiological Health, said, "The very low follow-up rate of Mentor is a very serious concern."

'Workload is increasing'

But Dr. al said that Mentor's performance did nothing to change his opinion of user fees and third-party reviews, both of which he favors. "Over a six- or eight-year period, our staff has dwindled down to a size smaller than it was in the early '90s," he said. "Technology is exploding, and the workload is increasing." Dr. al acknowledged the concerns of those who dislike the idea of outside device auditors assuming regulatory functions. "In this climate of people worrying about [corporate] integrity, it's a fair question to ask. How do you build protections into any kind of third-party audit system that doesn't get you into the same trouble as the financial auditors did?" he said. "We would expect to see the same kinds of write-ups and reports from third parties that we'd see from our own staff. We would still inspect the raw data. There would still be checks and balances in the system."

Dr. al pointed out that third parties already review, on a limited basis, low- and moderate-risk medical products, such as X-ray machines. The changes being pondered in Congress, however, would expand the program to implants and other devices that are placed permanently in the body – and can cause considerable harm if they fail.

'They all break'

According to Dr. Melmed, a Dallas plastic surgeon, there is no better example of this than breast implants. Dr. Melmed estimates that he has removed 700 silicone implants and 150 saline implants in the past decade. "I see more problems from them than benefits," he said. "They all break, given enough time. They all disintegrate. There's a tremendous amount of local complications."

The first silicone implants – silicone gel inside a silicone shell – were introduced some 40 years ago. Saline implants – sterile saline solution inside a silicone shell – came along a few years later but were far less popular because they looked and felt less natural than silicone.

Through the 1980s, both types of implants were treated as grandfathered devices by the FDA. Manufacturers were not required to conduct safety studies or otherwise justify the products' continued availability. By 1990, an estimated 750,000 women had had implants, some for breast reconstruction after cancer surgery but many for purely cosmetic reasons.

Most of the implants were silicone, which ruptured or leaked in some cases. Some women complained of debilitating systemic ailments whose symptoms included fatigue and memory loss. Others had localized problems, such as burning pain, breast hardening and disfigurement.

Silicone ban

In 1991, the FDA called for studies from the manufacturers. Dissatisfied with the data it received, the agency said that silicone implants would no longer be available to the general public and could be used only by participants in clinical trials. Mentor and other manufacturers turned their attention to saline implants, which are ostensibly safer than silicone because they do not contain the oily, and possibly toxic, gel. When women began to complain about saline implants, the FDA again called for studies.

By March 2000, products made by Mentor and Inamed, then called McGhan Medical, were up for approval. Although each had only three years' worth of patient data – hardly enough, critics said, to make valid assumptions about the implants' performance – complications already were appearing.

An FDA advisory panel nonetheless recommended approval for both manufacturers, providing they continued to track patients another seven years. The FDA took the panel's advice, granting approval in May 2000, even though it was in the midst of a criminal investigation of Mentor's manufacturing practices.

"I was naïve enough to think they were not going to be approved," said Eileen Swanson, a 51-year-old breast cancer survivor who had two sets of Mentor saline implants removed and still has pieces of the silicone shells embedded in her chest. Ms. Swanson runs a support group called Survivors of Salines.

Earlier this month, the panel was reconvened so that Mentor and Inamed could present their five-year study data. Twenty-six percent of Inamed's augmentation patients had undergone re-operation and 17 percent had experienced breast pain, among other complications.

Forty-five percent of Inamed's reconstruction patients had undergone re-operation and 39 percent had complained of asymmetrical breasts.

"These rates have been reviewed by the FDA and they're not concerned about them," said Nicholson, a spokesman for the company, based in Santa Barbara, Calif.

Many augmentation patients undergo re-operation by choice, seeking even larger breasts, Mr. Nicholson said. High rates of re-operation and other complications would be expected of reconstruction patients, already weakened and disfigured by cancer and cancer treatments, he said.

Because the Mentor studies were so deficient, FDA officials rejected the company's estimates of complication rates. Officials with Mentor, which is also based in Santa Barbara and has a manufacturing plant in Irving, declined to comment beyond a press release stating that "breast implants are safe and we will continue to manufacture them. Women want and need these products, they are well-informed and knowledgeable about them, and have the right to choose them."

Elevated cancer risks

Recent studies by the National Cancer Institute, however, found that both silicone and saline implant recipients face elevated cancer risks. And FDA studies found links between silicone implants and fibromyalgia (soft-tissue pain) and connective-tissue diseases. N. Dubler, director of the Division of Bioethics at Montefiore Medical Center in Bronx, N.Y., believes that both augmentation and reconstruction patients should still have access to implants. Ms. Dubler, who sat on both the 2000 and the 2002 advisory panels, said she heard no evidence suggesting that saline implants are inherently unsafe.

However, she said, she is bothered by the complication rates. "The issue is not a woman's right to choose," Ms. Dubler said. "I just wish the products between which they were choosing were better."