FDA panels put silicone breast implants back under microscope
But Jeffrey Kenkel, professor and vice chairman of the Department of Plastic Surgery at the University of Texas, Southwestern Medical School at Dallas and president of the American Society of Aesthetic Plastic Surgery, says the implants are still safe and effective. He says there are a number of well-designed studies that document that claim.
“I think both ASAPS as well as the FDA are confident that breast implants are safe and effective. We’re fortunate that we have a very high patient satisfaction rate - above 90%. Ninety percent of breast implant patients are happy with their outcome and report an improved quality of life and body image.”
Kenkel said the measures established five years ago by the FDA were very difficult because a study with 40,000 participants is very hard to track. “Multi-investigators have a difficult time getting patients who are feeling well and back to their normal routine after surgery to come back in for their follow-up.”
But Dorsey said she had a very different experience. “I was forced out of the study when I decided to remove the silicone implants to save my life,” she told the panel. “All of my records were deleted - as if I never existed.”
Dr. Edward Melmed, a plastic surgeon from Dallas, told the panel the implants were an “industrial toxin.”
“The symptoms, they are real,” he said. “I answer five to seven e-mails a night from women all over the world asking. ‘What do I do about these symptoms?’ “
Melmed said that by 10 years after patients get them, 50% of silicone implants rupture; 72% by 15 years; and 94% rupture by 20 years. “Why is the FDA continuing to allow a device to be placed in young women that is guaranteed to fail 80% in 10 years? Would they allow that in hip replacements? Would they allow it in men?”
According to ASAPS, more then 318,000 breast augmentations were done in 2010 - more than any other surgical procedure. Sixty-two percent of those were silicone implants.
Both Mentor and Allergan’s implants come with a warranty that offers free replacement in case of rupture or deflation. It offers surgical cost assistance for replacement surgery.
Another hotly debated topic was MRI screening. Product labeling calls for patients to get an MRI three years after implantation and then every two years after. MRI picks up about 90% of ruptures, but the procedure is costly and some experts expressed concern over false positive readings.
But the FDA says the MRI is the gold standard for detecting silent rupture. The agency says it will continue to look into its clinical value. Looking to the future, the agency said it will see the current studies completed, make sure follow-up rates improve and will look into the creation of a breast implant registry - possibly on an international scale.
Mentor recommended a number of ways to get robust data on long-term safety, including enhanced post-market surveillance, and reviewing published literature and existing external databases like TOPS - a physician website managed by the American Society of Plastic Surgery.
“We believe these sources may provide the data FDA requires on potential medical conditions in women with breast implants and would most likely capture any early ‘safety signals,’ ” Allman said. “This therefore reduces the need for another large epidemiological study. If any new safety signals are identified, we would work with the FDA to define a targeted study design.”
FDA spokeswoman Erica Jefferson said the agency has a lot to consider. “The past two days have provided some very compelling information for the FDA. We took away several meaningful recommendations during the meeting.”
Jefferson said the FDA’s next step will be to review the recommendations and outline the suggestions they think should be implemented. They plan to engage stakeholders including sponsors, professional groups, patients, consumer groups and academia before making any decisions.
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By Saundra Young, CNN