A report by the U.S. Food and Drug Administration released Wednesday says silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled despite frequent local complications and adverse outcomes.
"The benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use," the report says.
"(However), the longer a woman has breast implants, the more likely she is to experience local complications or adverse outcomes and women with breast implants will need to monitor their breasts for local complications for the rest of their lives."
There is no apparent association between silicone gel-filled breast implants and connective tissue disease, breast cancer or reproductive problems, but these associations may take many years to manifest and may not be detected using currently available data.
The most frequent complications and adverse outcomes experienced by breast implant patients include:
-- 20 percent to 40 percent of augmentation patients and 40 percent to 70 percent of breast reconstruction patients had subsequent operations during the first eight to 10 years after they received their implants.
-- Other frequent complications include implant rupture, wrinkling, asymmetry, scarring, pain and infection, among others.
-- Women with breast implants may have a very small but increased likelihood of being diagnosed with anaplastic large cell lymphoma.