Silicone Breast Implant Approval Raises Questions, Concerns
Silicone Breast Implant Approval Raises Questions, Concerns
December 4, 2006 -
The recent approval of silicone breast implants for use in women age 22 and older has prompted a flood of phone calls to plastic surgery offices across the nation. Despite the excited flurry of calls, plastic surgeons are cautious over the newly approved implants.
According to Dr. Walter Erhardt - chairman of the American Society of Plastic Surgeons’ public education committee - the Food and Drug Administration’s decision to approve silicone implants has created “a whole host of questions” for women and their doctors.
The Question of Cost
Primary among those questions is that of cost. The FDA recommends that women who opt for silicone implants undergo periodic medical exams, including magnetic resonance imaging (MRI), to check for ruptures.
FDA safety guidelines specifically recommend that silicone implant recipients have an MRI three years after the initial procedure and then every two years thereafter. In instances where a leak or rupture is detected, the FDA recommends the implant be replaced.
However, cosmetic breast augmentation is considered an elective surgery and is generally not covered by medical insurance. This means that postoperative check-ups and any additional surgery may not be covered either.
The FDA noted that the cost of periodic MRIs and any subsequent surgery “may exceed the cost” of the initial surgery.
Other Important Questions
Other pertinent questions raised by the FDA’s recent decision to approve silicone implants include:
- What happens if the patient fails to pursue follow-up care?
- Must ruptured implants always be removed and replace?
- Who is financially responsible for the costs associated with removing/replacing a ruptured implant?
In fact, plastic surgeons don’t even agree on whether or not ruptured implants should be removed at all. Chicago plastic surgeon Dr. Laurie Casas says broken implants “should be replaced, as you would any broken device.”
Dr. Richard Ellenbogen, a Beverly Hills plastic surgeon, disagrees, “If it ain’t broke, why fix it? Why submit a woman to that trauma?”
It’s not surprising that such questions, particularly those involving follow-up care, are dampening the initial enthusiasm for the FDA’s decision.
“Most women want to put them in, go on with their lives and forget they got the surgery. That’ll be a big question, whether they’re going to want to be burdened with that follow-up,” said Dr. Ellenbogen.
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