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Key Points
- The makers of silicone gel breast implants finally received FDA approval to market the next-generation implants, but conditions for approval will have the companies keeping close tabs on the products for years to come
- FDA mandates to the manufacturers range from 10-year-long post-approval studies to detailed, patient education-oriented labeling requirements
NATIONAL REPORT — The approval last November of silicone gel-filled breast implants by the Food and Drug Administration (FDA) was conditional on a lengthy list of post-approval requirements that will keep manufacturers Allergan Corp. and Mentor Corp. detailing every aspect of the implants for years to come — and the mandates don't end at the cleanroom door, one expert tells
Cosmetic Surgery Times.
Scientific review for the approval was especially rigorous, and the conditions for the approval were likewise extensive in light of the high-profile historical concerns about the implants, particularly the issue of the potential for systemic disease.
"The FDA's concern about a possible connection with systemic diseases was really the crux of why silicone gel breast implants were taken off the market 14 years ago, but now there are enough studies indicating that that is essentially no longer a concern," said Michael Olding, M.D., F.A.C.S., chief of plastic surgery at George Washington University Hospital in Washington, D.C., who also serves on the FDA's general and plastic surgery device panel.
Aside from a requirement that patients be of age 22 or older to receive the implants for breast augmentation, a constraint that he characterized as "unusual," Dr. Olding said the FDA's post-market conditions are not unexpected. "[The post-market] requirements are not so terribly unusual given that there has been so much discussion about silicone breast implants over the last 14 years," he says. "The FDA is being very cautious — and appropriately so."
LONG-TERM TRACKING Leading the list of the FDA's conditions for the silicone gel breast implants is the requirement that the manufacturers continue their core studies until all patients have completed a 10-year evaluation to assess the long-term clinical performance of the devices.
Allergan reports that its Core Clinical Study, which is ongoing, is a 10-year prospective multi-center safety study involving 715 women who have undergone breast augmentation, reconstruction or revision surgery. Four-year data from that study showed that ruptures had occurred in less than one percent of implants.
According to the FDA's requirements, all participants in the core studies must receive regular exams to detect rupture, and MRIs will be required every other year. The manufacturers will also need to evaluate all patients whose breast implants were removed without replacement for 10 years.
In addition to the core studies, implant manufacturers are required to conduct separate 10-year post-approval studies involving approximately 40,000 silicone breast implant patients and a control group of patients who received saline-filled breast implants.
The large post-approval studies track data on a wide variety of requisite endpoints including local complications; signs, symptoms and rates of neurological and connective tissue diseases; the potential effects on offspring of women with breast implants; potential effects on reproduction and lactation; implant recipients' rates of cancer and suicide; potential interference of silicone implants with mammography; and patient compliance with MRI recommendations and rupture rates.
The FDA has also mandated an annual survey of study participants. Mentor's study participants are required to have physical evaluations for local complication data at years one, four through six, nine, and 10. Allergan study participants will need evaluations at years one, four and 10, according to the FDA.
The FDA will post the status of the silicone gel implant studies on its Web site, and will hold open public meetings to follow-up on the status of conditions at five and 10-year points following approval — in addition to any other time the agency finds such meetings necessary. Beyond core and post-approval studies, the companies face broad-ranging requirements:
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Lab studies will need to be continued over a 10-year period to better understand modes and causes of failure leading to device removal.
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New patient enrollment in adjunct studies must be curtailed.
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Patients currently enrolled must be followed through the final 5-year study time point.
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Tracking of the devices must take place from their manufacture through the distribution chain to implantation.
Labeling requirements mandated for the breast implants include informing women that breast implants are not lifetime devices and will likely need to be replaced at least once in a woman's lifetime. Labels will also explain that changes to the breasts following implantation are often irreversible and that rupture of a silicone gel-filled breast implant is typically "silent" — meaning neither the woman nor her surgeon will likely know if the implants have ruptured.
Additionally, labels must notify women that they will need to have an MRI three years following the initial implant surgery and every two years thereafter, and that the cost of the screening may not be covered by medical insurance and may, in fact, exceed the cost of the initial surgery.
For their part, surgeons wishing to use the implants are required to participate in the companies' physician training program.
Dr. Olding feels the requirements appropriately address the exceptional level of controversy surrounding the silicone implants.
"This was an emotional issue and there was a lot of misinformation and anecdotal information during the 14 years that the implants were off the market," he says. "The implants received more scrutiny than any other plastic surgical device to date. In the long run, I think science trumped emotion and I applaud the FDA's decision."
