Up to a quarter of women seeking saline breast implants for cosmetic reasons end up having replacement operations within five years, United States federal health advisers have been told.
The Food and Drug Administration will put the failure data in brochures given to patients before surgery but the advisory panel, sitting
in Gaithersburg, Maryland, urged makers of the implants to better monitor their performance.
"The high re-operation rate would not be acceptable in other types of prosthetic devices," said panellist Dr Amy Newburger, from White Plains Hospital Medical Centre.
Silicone breast implants were banned by the FDA in 1992 over concerns that they were causing auto-immune disease, but limited numbers have been allowed under rules restricting use to clinical studies.
Saline implants remained on the market, but the agency asked for new safety data.
After reviewing studies, the administration said in May 2000 that the implants could be marketed.
As a condition of the approval, FDA required 10 years of further studies.
The administration's advisory committee members heard reports from saline implant maker Inamed's McGhan Medical unit and Mentor, the only other US company that makes breast implants.
Mentor, which was criticised for its small study population, said 20 per cent 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, Mentor said.
McGhan said 25 per cent of its augmentation group had a second operation.
Both manufacturers said 43 per cent of patients seeking reconstruction after cancer surgery had a second operation.
Mentor aimed to monitor its original 1600 implant recipients, but said it had trouble tracking down those women, and only had full data on 60 patients.
Panellists were not impressed.
"These are scientifically suspect data, just because of the low numbers," said Dr Phyllis Chang, an associate professor of the University of Iowa College of Medicine.
McGhan's presentation last week, based on 1100 women, appeared to soothe some concerns.
"I certainly feel much more satisfied, with the data presented this afternoon, and reassured by it," said Dr Michael Miller, of the University of Texas MD Anderson Cancer Centre.
- REUTERS
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