Fw: Many with Breast Implants Have 2nd Operation

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Martha Murdock, DirectorNational Silicone Implant Foundation | Dallas Headquarters"Supporting Survivors of Medical Implant Devices"4416 Willow LaneDallas, TX 75244-7537

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Sent: Saturday, July 13, 2002 11:59 PM

Subject: Many with Breast Implants Have 2nd Operation

Many with Breast Implants Have 2nd OperationWed Jul 10,10:41 AM ETBy Ault GAITHERSBURG (Reuters) - Up to a quarter of women seeking saline breast implants for cosmetic reasons end up having replacement operations within five years, federal health advisers heard on Tuesday. The Food and Drug Administration ( news - web sites) will put the failure data in brochures given to patients before surgery but the advisory panel urged makers of the implants to better monitor their performance. "The high re-operation rate wouldn't be acceptable in other types of prosthetic devices," said panelist Amy Newburger from White Plains Hospital Medical Center. The FDA banned silicone breast implants in 1992 over concerns they were causing autoimmune disease, but limited numbers have been allowed under rules restricting use to clinical studies. Saline implants remained on the market, but t! he agency asked for new safety data. After reviewing studies, the FDA said in May 2000 that the implants could be marketed. As a condition of the approval, FDA required 10 years of further studies. FDA advisory committee members heard reports from saline implant makers Mentor Corp. and Inamed Corp.'s McGhan Medical unit. Mentor, which was criticized for its small study population, said 20% of women seeking breast augmentation sought a second operation, mainly because a hard capsule had formed around the implant. Women also requested new implants because they wanted to change sizes, or because of leaks and deflation, said Mentor. McGhan said 25% of its augmentation group had a second operation. Both manufacturers said 43% of patients seeking reconstruction after cancer surgery had a second operation. Mentor aimed to monitor its original 1,600 implant recipients, but said it had trouble tracking down those women, and only had full data on 60 patients. Panelists weren't impress! ed. "These are scientifically suspect data, just because of the low numbers," said Phyllis Chang of the University of Iowa College of Medicine. McGhan's presentation on Tuesday afternoon, based on 1,100 women, appeared to soothe some concerns. "I certainly feel much more satisfied, with the data presented this afternoon, and reassured by it," said of the University of Texas M.D. Cancer Center.