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It's unclear whether health insurance companies will cover medical complications and monitoring of silicone breast implants after the Food and Drug Administration lifted its 14-year ban on silicone implants last month.
The FDA is warning women who choose to have breast enhancement surgery that health insurers may not pay for such follow-up magnetic resonance imaging screenings to look for implant ruptures and leaks or the resurgeries that are often required years after the initial procedure.
Silicone implants, like less controversial saline implants, come with a list of warnings that include rupture and capsular contracture--the painful formation of scar tissue around the implants. Unlike saline implants, researchers say silicone implants can rupture "silently" and that a woman may not know that her implant is not intact. Saline implants typically deflate once ruptured, making the incident more noticeable.
Because of the unique risks associated with silicone implants, the FDA requires that women be urged by the companies selling the implants to have MRI screenings every two years, beginning three years after their surgery.
The cost for MRIs--about $2,000--will likely not be covered by insurers, the FDA warns, and that women could spend more money on their silicone implants throughout their lifetime than the cost for their initial operation.
The two companies now selling silicone implants with the FDA's new approval are offering to help women with some of the follow-up costs.
The Santa Barbara, Calif.-based Mentor Corp. will replace implants for women who experience ruptures and will provide $1,200 to help offset resurgery costs within five years of their initial surgery. In addition, women who purchase an enhanced warranty will receive up to $2,400 to offset reoperation costs within 10 years. The Irvine, Calif.-based Allergan Inc. will also replace ruptured implants and will pay $1,200 of the resurgery costs within 10 years, or with an enhanced warranty, cover $2,400 of the costs.
Initial surgeries for silicone implants typically cost $10,000 or more, depending on the location and status of the clinic. Resurgeries can cost slightly more, depending on the complication.
Most, if not all, major insurance companies do not cover cosmetic breast surgery, but are required by law to pay for reconstructive surgery for women who have undergone a mastectomy following cancer.
Since the FDA's ban on silicone implants in 1992, only women who have had breast cancer were able to still opt for silicone. Women who did not have a mastectomy and who wanted to replace their older silicone implants could only do so using saline implants.
A spokeswoman for Hartford, Conn.-based Aetna Inc. said the health insurer's current policies will cover MRIs for women with silicone implants and surgeries to remove them, but that their polices will likely be revised given the FDA's latest decision. She did not elaborate on the possible changes.
Meanwhile, a Washington-based spokesman for the Blue Cross Blue Shield Assn. said it was too soon for individual Blues plans to comment on whether they will need help to pay for silicone implant-related complications and testing, but that most insurance providers will not cover plastic surgery-related issues.
The National Research Center for Women and Families, a Washington-based nonprofit advocacy group that opposed the FDA's decision, issued a statement urging women to check with their insurance providers before electing to have surgery and that some providers may eventually deny coverage to women with silicone implants because of the complications.