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 doctors told government advisers today.
Testimony from many of the 200 patients, doctors and consumer advocates who signed up to speak at a hearing focused on the risk that implanted devices may leak silicone, which has been linked to connective-tissue disorders and pain. The Food and Drug Administration staff projected that easing the limits might result in 22,500 silicone device ruptures a year.
``Even the companies' data, which will put on the best face, will not dispute a significant rupture rate,'' Audrey Sheppard, who directed the FDA's Office of Women's Health from 1996 to 1999, told the panel. ``These are not lifetime devices.''
The committee of doctors and scientists at this week's three- day hearing will vote on whether the FDA should allow sales of the implants. The agency 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 Vioxx because of a link to heart attacks and strokes.
Mentor shares rose 37 cents to $34.56 at 4:16 p.m. in New York Stock Exchange composite trading. They have gained 2.4 percent this year. Inamed shares climbed 6 cents to $65.65 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.
Technical Advances
U.S. regulators banned most use of silicone implants in 1992 after they were linked to diseases such as rheumatoid arthritis. Leaking implants allow silicone gel to move to the area surrounding the breast, and the material has been found in lymph nodes. 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 its silicone implants.
Technical advances have since improved the safety of silicone implants, said Inamed and Mentor, both based in Santa Barbara, California, in FDA filings. The companies submitted findings from studies of rupture rates. Inamed, whose last application was rejected in 2004, presented data from a year's additional study. Mentor's application is new.
Preference for Silicone
Inamed paid for Anna Daly, a 40-year-old homemaker from Nashville, Tennessee, to travel to the meeting in Gaithersburg, Maryland, and tell the panel why she prefers her silicone implants. She said she previously had breast devices filled with a saline solution that moved as she walked and had a ``rippled appearance.'' ``I like the projection of my breasts that silicone-filled implants provide because it is very natural,'' Daly said. ``They are as close to the feel of my own breasts as I could have imagined.''
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.
`Toxic Secret'
Health insurers refuse to cover women who have had breast implants, said Pam Dowd of Boise, Idaho. She and her 22-year-old daughter Brenna 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.''
Spokesmen Jim Kappel of WellPoint Inc., the biggest U.S. health insurer, and Mark Lindsay of UnitedHealth Group Inc., the second-largest, didn't immediately return phone calls seeking comment on their underwriting policies for women who have had silicone implants. Laurita Warner, spokeswoman for No. 2 U.S. life insurer Prudential Financial Inc., said the company doesn't have any questions about breast implants on its life insurance applications. 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.
Benefits and Risks
``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.''
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.
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.
