Date: Fri, 3 Mar 2000 01:32:51 -0700

FDA panel deems 2 of 3 breast implant brands safe

By Lisa Richwine

GAITHERSBURG, Md., March 2 (Reuters) - The two most popular brands of saline-filled breast implants are safe and effective and should stay on the U.S. market, a federal advisory panel said Thursday after reviewing new data on possible complications.

The committee said, however, that the company that makes a third brand of saline implants did not present enough information to prove the benefits of its product outweighed its risks.

Saline implants first hit the market more than 25 years ago when the FDA had no authority to determine whether they were safe. The agency is scrutinizing them now because of concerns about complications such as infections and rupturing.

The FDA usually follows its panels' advice and is expected to decide whether to officially approve the implants later this year.

Breast implants are more popular than ever. About 150,000 women received them last year. Most are filled with saline, or salt water. Silicone-gel implants were banned for most women in 1992 over safety concerns.

The panel recommended the FDA approve implants made by Inamed Inc.'s McGhan Medical unit and Mentor Corp. two California companies that lead the breast implant market.

"The data shows these implants are reasonably safe and effective," said panel member Dr. Phyllis Chang of The University of Iowa College of Medicine after studying McGhan's results.

But panelists said they were not reassured by data from Poly Implant Prostheses (PIP). They said the U.S. study the company presented did not include enough patients that were followed for an adequate time to truly evaluate the device risks.

Panel member Boyd Burkhardt, a plastic surgeon from Arizona, said he wanted to support PIP's implants because he thought their design would "dramatically" reduce the rate of infections. But he found the company's data incomplete and found it difficult to understand that the company was "as ill prepared as you appear to be."

PIP President Rick Hawk responded by saying the study results showed there was, "reasonable assurance of PIP's implant safety and effectiveness."

Earlier, McGhan said a one-year study of more than 2,500 women showed the most common problem was contraction of scar tissue around the implants, which can cause changes in breast appearance and deflation. That occurred in 7.2 percent of women who had breast augmentation and in 12.5 percent of women who had breast reconstruction.

Leakage or deflation happened to 3.6 percent of women who had augmentation and 2.6 percent of reconstruction patients.

An FDA official who analyzed the company's studies said the risk of complications increased over time. Dr. Sahar Dawisha said 95 percent of reconstruction patients had reported some type of complication after five years.

Studies on serious ailments such as connective tissue or autoimmune diseases were not designed well enough to draw any conclusions about whether they were related to the implants, Dawisha said.

19:57 03-02-00

Panel OKs Breast Implant Brands

.c The Associated Press

WASHINGTON (AP) - A federal advisory panel recommended Thursday that a second major manufacturer of saline-filled breast implants be allowed to stay on the market.

Advisers to the Food and Drug Administration backed the implants made by McGhan Medical Corp., one day after making a similar recommendation that competitor Mentor Corp. be allowed to continue selling its brand of saline implants.

The two Santa Barbara, Calif., companies are the largest makers of breast implants.

But the FDA advisers recommended that women getting saline implants be warned that they can deflate and require repeated operations. The FDA panel was to spend Friday determining just how the government should word those warnings.

And in another action, the FDA advisers voted unanimously late Thursday that a small implant maker, PIP/USA of Miami, did not prove its brand of saline implants were safe and effective. Panelists rejected PIP's implants largely because the company's study of the product is incomplete, an FDA spokeswoman said.

An estimated 130,000 American women received saline-filled breast implants last year even though the FDA has never declared these implants safe: They hit the market before the FDA began regulating medical devices.

But the FDA recently decided saline implants can continue selling only if manufacturers prove they truly are safe, and asked its scientific advisers to evaluate the issue. The FDA is not bound by advisory panel recommendations but typically follows them, and is scheduled to make a decision on the three manufacturers' products by mid-May.

In 1992, the FDA banned most use of silicone gel-filled breast implants.