Breast implant debate rages in US
The US Food and Drug Administration’s (FDA) advisory council is considering whether or not controversial silicone breast implants should return to the market.
Experts listened to dozens of women on Tuesday who described the implants as either dangerous or safe, natural-looking breast enhancers.
The United States banned silicone implants for most women in 1992, amid controversy over their safety.
But major scientific studies failed to find evidence that silicone implants caused chronic diseases, although many women are convinced that leaking silicone made them ill.
“My body was racked with joint pain” after getting silicone implants, Susan Cunningham told the panel. Her health improved after she had the implants removed, but she is still too sick to work, she said.
Carolyn Wolf said she got silicone implants in 1971, following a double mastectomy. She experienced no problems for about 10 years.
|
“We beg you, please protect the younger generation” Carolyn Wolf, |
Migrating silicone
But later she had blisters on her neck, rheumatoid arthritis and neurological damage to an eye, as silicone migrated throughout her body and deposited in her armpits.
One eye had constant pain for six weeks. “After a long, thin, greasy glob came out, the pain lessened,” she said, but silicone still oozes from her nipples.
“We beg you, please protect the younger generation,” Wolf said.
Breast implants were pushed into the spotlight this month, and even became an election issue for California-hopeful Mary Carey who was offering all voters cheaper implants.
Studies have found both silicone and saline-filled implants frequently rupture and cause local complications such as pain and scarring. Silicone implants now are available only through clinical trials, while saline implants are widely accessible.
Other speakers said they were pleased with their silicone implants, which they chose to get a more natural look and feel than saline implants offered.
‘No regrets’
“I have had absolutely no complications or regrets about that decision,” said Cindy Teague, who got implants after her breast appearance changed following child birth.
Proponents argued women have a right to choose silicone implants, either for rebuilding breasts after cancer surgery or for cosmetic reasons.
|
“I have had absolutely no complications or regrets about that decision” Cindy Teague |
As long as they are told of the risks, “let women make informed decisions about their bodies,” said Michele Colombo, a 34-year-old married woman who said she was considering breast implants to enhance her appearance.
In a study conducted by breast implant manufacturer, Inamed, 940 women, followed for up to three years, showed little signs of problems according to the company.
Rates for most complications were lower than with Inamed’s FDA-approved saline implants, said JoAnn Kuhne, Inamed’s senior director for regulatory and clinical affairs.
‘Happy customers’
“Patient satisfaction was extremely high,” Kuhne said. Up to 96% of women said they were happy with the implants two years after their surgery.
Among women who got implants for cosmetic reasons, nearly 21% needed a repeat operation, as did nearly 46% of women who had breast reconstruction, Kuhne said.
The rupture rate was 1.2% for women who had breast augmentation, and 6.3% for breast reconstruction patients.
The advisory panel is scheduled to vote by Wednesday on whether to recommend FDA approval for Inamed’s implants. The FDA usually follows the advice of its panels.
Shares of California-based Inamed were halted during the panel meeting.