WEDNESDAY, June 22 (HealthDay News) -- Silicone-gel breast implants don't last forever, with as many as half of women with the devices requiring removal within 10 years of the initial surgery, U.S. health officials said Wednesday.
And "the longer a woman has the implants, the more likely she is to experience complications," Dr. Jeffrey Shuren, director for the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, said during a press briefing.
The report released Wednesday said one in five women who receives silicone-gel implants to increase the size of their breasts will need to have these devices removed within 10 years of implant due to complications. And as many as half of women who receive implants for reconstruction after breast surgery will need them removed within the same time frame.
The difference in rates has to do with how much healthy tissue the woman has to support the implants, Shuren explained.
Common complications include: capsular contracture, which is hardening of the area around the implant; the need for additional surgeries; and implant removal. Other frequent problems include implant rupture, wrinkling, breast asymmetry, scarring, pain and infection, the FDA said.
These are basically the same complications noted when the two silicone-gel implants available in the United States were returned to the market in 2006, the FDA said.
Until 2006, silicone-gel implants had been banned by the FDA for 14 years because of concerns about possible links to several diseases, including cancer and lupus.
On Wednesday, Shuren said, "Preliminary data doesn't show an increased risk of breast cancer or connective tissue disease such as rheumatoid arthritis. But to rule those out, we need studies that are larger and longer than those conducted thus far."
The FDA had said recently that breast implants may be linke
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