Silicone Implants and the FDA continued...
These concerns caused the FDA to ban the sale of silicone breast implants in 1992, except for use in clinical trials. The ban also prompted a string of lawsuits against implant manufacturers from women who said they suffered health problems or disfiguration as a result of their silicone breast implants.
In December 2002, Inamed filed a product marketing application with the FDA for a silicone implant based on the results of their own study of 1,000 women with the implants who were followed for at least three years as well as other research published since the ban was enacted.
Inamed's competitor, Mentor, says it plans a similar filing later this year for its silicone breast implant.
Assessing the Risks
In 1999, a report from the Institute of Medicine stated that women with silicone breast implants are no more likely to develop life-threatening illnesses, but it's clear that they can cause serious problems.
Researchers found that the most serious complications associated with silicone breast implants occur when the tissue around them contracts, when the implant ruptures, or when infection occurs. The risk of these problems increases with time. Studies have shown that about 26% of silicone implants rupture after 12 years and 55% after about 16 years.
"As with any type of implant or medical device, there are going to be local complications, and breast implants are no different," Khune tells WebMD. "No implant is risk free, and no device can claim to last forever."
Research submitted to the FDA by Inamed shows that most implant ruptures were revealed by MRI screening conducted as a part of its clinical trial. But experts are concerned that these "silent ruptures" may go undetected for years and cause serious problems or deformities in women without adequate screening procedures in place for all women with silicone implants.
Zuckerman says that silicone gel eventually starts to break down and when it leaks and spreads into the body, it causes lumps under the skin that can be a real mess to clean up surgically.