April 11 (Bloomberg) -- Mentor Corp. and Inamed Corp.'s silicone breast implants aren't any safer than when U.S. regulators banned earlier devices 13 years ago, patients and their advocates told government advisers today.

The companies haven't studied the health effects of silicone leakage, known as extracapsular rupture, and one study included just 23 women, said Kathy L. Keithley Johnston, executive director of Columbia, Missouri-based consumer group Toxic Discovery.

``You would think that after 40 years, implant manufacturers should find more than 23 women with extracapsular rupture,'' Johnston said. ``Without a doubt, there are'' more than that many women attending today's hearing at a hotel in Gaithersburg, Maryland, she said.

The testimony is part of a three-day meeting of doctors and scientists who will vote on whether the Food and Drug Administration should allow sales of the implants. The FDA is under pressure from Congress over its monitoring of medical safety. Last week regulators asked Pfizer Inc. to withdraw its Bextra painkiller because of heart and skin risks, six months after Merck & Co. recalled the similar Vioxx pain drug over a link to heart attacks and strokes.

Inamed and Mentor, both based in Santa Barbara, California, said in their filings with the FDA that data they gathered showed their silicone implants are safe.

Mentor shares rose 27 cents to $34.46 at 11:05 a.m. New York time in New York Stock Exchange composite trading. They have risen 2.1 percent this year. Inamed shares fell 57 cents to $65.02 in Nasdaq Stock Market composite trading. Medicis Pharmaceutical Corp., based in Scottsdale, Arizona, said March 21 that it intends to buy Inamed for about $2.8 billion in cash and stock.

Almost 200 critics and supporters of silicone implants registered to speak at today's session, which the FDA scheduled to run at least until 11 p.m. By late this morning, more than 20 people had argued against easing limits on silicone implants and a handful defended the devices.

In a half-filled hotel conference room, a parade of patients, doctors and consumer advocates told of debilitating health problems that they related to ruptures of silicone implants, including breast cancer, connective-tissue disorders, pain and depression, some of it linked to suicides.

Health insurers refuse to cover women who have had breast implants, said Pam Dowd of Boise, Idaho. She and her daughter said they drove almost 2,500 miles in a 1984 Southwind motor home to the hearing at their own expense. Dowd attributed years of health problems, including pain in her bones, to three ruptured silicone implants.

``What is the toxic secret that the insurance companies know but are not sharing?'' Dowd said. ``I am 57, uninsured and uninsurable.''

Dowd's 22-year-old daughter, Brenna Dowd, elaborate on her mother's health.

``Mom would never people about all the times she has been unable to walk right, sometimes crawling, many times falling,'' she said. ``She would never tell you about the times when she gets confused, or when her legs hurt so much she has to sit in hot water three times a day to ease the pain.

The FDA staff last week projected that broadened sales of the devices might lead to as many as 22,500 cases a year of ruptured implants, based on a review of company and other studies. In 1998, Dow Corning Corp. agreed to pay as much as $3.2 billion over 16 years to settle claims of more than 300,000 women who said they were harmed by the company's silicone implants.

Some doctors argued in favor of the devices. Caroline Glicksman, a plastic surgeon from Red Bank, New Jersey, said a substantial body of evidence supports approval, including research from the Mayo Clinic and the Institute of Medicine.

``Like all drugs and medical devices, breast implants have benefits and risks,'' Glicksman testified. ``Opponents of wider availability of silicone implants have no scientific legs on which to stand.''

U.S. regulators banned most use of silicone implants in 1992 because the devices might cause connective-tissue diseases such as rheumatoid arthritis. The conditions occur when the body's immune system attacks its own tissue. Leaking implants allow silicone gel to move to the area surrounding the breast, and the material has been found in lymph nodes.

While the agency has never approved a silicone breast implant, the devices are sold in the U.S. for use in research in women who have lost their breasts or have deformities. Silicone implants already were on the U.S. market in 1976 when the FDA was given authority to regulate medical devices.

The FDA usually follows the advice of its panels. The agency named as chairman cancer surgeon Michael A. Choti, 47, a professor at Johns Hopkins University in Baltimore, who voted against resuming silicone breast implant sales in 2003. Three others on this week's 12-member panel voted against the devices at the October 2003 meeting.

One of the four members of this year's committee who favored approval of silicone implants in 2003 withdrew today. Michael Olding, chief of plastic surgery at George Washington University School of Medicine, said in a letter to the panel that he had a potential conflict of interest.

Lazard Freres & Co. analyst Alex Arrow last week predicted that the companies' applications would fail on a 6-5 vote. Hibernia South Coast analyst Julie Schumacher Hoggatt said in an April 7 note that she expects the FDA to clear both applications.

Implants for cosmetic use have been filled with a saline solution. Inamed sells saline implants for $300 to $400 each, and silicone devices for use in studies for about twice as much. U.S. sales of implants to enlarge healthy breasts, now a $300 million annual market, may rise by $60 million following an end to the ban on silicone devices, said Juan Noble, an Oppenheimer & Co. analyst in New York.

Kerry Dooley Young in Gaithersburg, Maryland, at

1120 or kdooley@bloomberg.net

To contact the editor responsible for this story:

Robert Simison at rsimison@bloomberg.net

Last Updated: April 11, 2005 11:11 EDT