FDA panel hears follow-up data on saline breast implants

GAITHERSBURG, Md. (AP) _ Debate over the safety of breast implants continues to rage two years after the government allowed the saline-filled devices to remain on the market. <br><br>A government advisory

Wednesday, July 10th 2002, 12:00 am

By: News On 6

GAITHERSBURG, Md. (AP) _ Debate over the safety of breast implants continues to rage two years after the government allowed the saline-filled devices to remain on the market.

A government advisory panel on Tuesday called for better follow-up studies and questioned how likely women with implants are to have additional surgery within five years. The panel heard some patients praise implants, while others condemned them.

The Food and Drug advisory panel was especially concerned with studies indicating that 20 percent or more of women with implants had further surgery within five years.

``Clearly a woman has a right to choose,'' said Nancy A. Dubler of Alfred Einstein College of Medicine in New York. ``The problem is she has the right to choose between products that, by their own data, aren't terrific.''

Dr. Michael A. Choti of the Johns Hopkins School of Medicine in Baltimore added ``these products have problems. ... There's clearly a mandate to improve.''

Tammy Griffiths, who described herself as a mother of four from Texas, said she was delighted with implants.

``I made a decision to have the surgery and I have never regretted it,'' she said. ``I feel better about myself and more confident in my physical appearance.''

Cheryl Valput agreed: ``This was the best decision that I have made in my life.'' Valput said she was from Ohio but neither gave a hometown.

But actress Mary McDonough, who said she decided to have implants after leaving the television show The Waltons, where she played Erin, called the surgery ``a decision I very much regret'' because of continuing health problems.

The FDA approved the implants two years ago, setting a series of conditions, including a follow-up study.

But response rates were low, despite efforts to contact women who took part in clinical trials of the implants prior to approval.

Five years after their surgery, one study was able to contact just 5 percent of women who received implants for breast enlargement during pre-approval trials. For women who got the implants for reconstruction after surgery the rate was higher, 52 percent.

That study found a 20 percent chance of the women having another surgery in five years for the enlargement group and 43 percent for reconstruction patients.

The most common reason for the second surgery was cosmetic _ to change breast size, clear up scars or ease wrinkling. However, many were more serious, including deflated or leaking implants or infection.

Several witnesses stressed the right of women to choose implants and panel members seemed to agree, but were concerned about whether enough information was available for them to make an informed decision.

David L. DeMets of the University of Wisconsin, Madison, was highly critical of the lack of follow-up data and pressed the FDA and the companies that make the implants to work harder to collect data from patients.

Cliff Kline of Mentor Corp., an implant maker, said his company is continuing efforts and hopes to reach a 60 percent response level by 10 years after women's surgery.

Some panel members questioned why women who have the implants removed are then dropped from follow-ups. Kline responded that they are no longer considered likely to suffer complications from the implants once they have been removed.

A second manufacturer, Inamed, was more successful in conducting follow-ups, reaching about 80 percent of patients after five years, a result that pleased the panel.

In that study, women who received the implants for breast enlargement had a 25 percent rate of another operation in five years. The rate was 45 percent for those who had the implants for reconstructive reasons.

Even with the 80 percent response rate, DeMets, a professor of biostatistics, said there was still room for concern and urged the companies to get the rate up to avoid controversy and concern.

He urged the establishment of a national registry of implant patients so they can be tracked.