|
November 2006 --The FDA approved widespread use of silicone breast implants,
14 years after the agency imposed a moritorium on the devices over questions of safety. Silicone implants are now approved
"for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older."
In the U.S.,
silicone implants are manufactured and sold by just two companies: Inamed Aesthetics (now owned by Allergan, the company that
makes Botox) and Mentor.
Since 1992, amid safety fears and lawsuits, silicone implants have been available for reconstruction
after breast cancer only to women who agreed to be followed for 5 years, and whose plastic surgeon participated in a national
study.
While virtually all studies failed to link silicone implants to serious diseases such as cancer, lupus, and
autoimmune disorders, concerns remain over how often the implants rupture and what happens when and if silicone migrates from
the breast to the rest of the body. In 2000, the Institute of Medicine reported a 77% rupture rate from silicone implants.
In April 2005, Inamed reported its silicone implants have a 14% chance of rupturing over 10-years. Mentor said its implants
had a negligible rupture rate over 3-years. While older implants contained liquid silicone that could leak outside the shell,
newer silicone implants contain silicone gel with a gummy-bear consistency.
Under the new approval, Inamed and Mentor
each are to study 40,000 women for 10 years to assess potential problems. Under the new rules, plastic surgeons must inform
women that implants may rupture and must be replaced sooner or later. The FDA suggested women have periodic MRIs to determine
whether a rupture has occurred (it's not always apparent).
Like so many things in life, whether you select silicone
implants for your reconstruction is a very personal decision. If you're considering silicone implants, be sure to do your
homework. Understand the potential issues concerning ruptures and that your implant will eventually need to be surgically
replaced. Weigh the benefits and limitations of silicone implants and make an informed decision.
|
