The U.S. Food & Drug Administration released updated information about gel-filled breast implants five years after approving them for clinical use, warning that they often cause complications that need additional surgery or removal.
The report confirms previous findings and asserts that the implants are safe when used as intended, but highlights the need to inform women considering the procedure that the implants won’t last forever.
"The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications," the report notes, adding that 20 percent of implants used for augmentation will require removal within 10 years, as will half of implants used for reconstruction.
The report includes safety data from Allergan Inc. (NYSE:AGN) and Johnson & Johnson (NYSE: JNJ), who essentially control the breast implant market.
The companies’ FDA clearance hinged on post-approval studies of the implants to characterize long-term performance and safety.
"The complications that existed for women receiving breast implants at the time of approval are similar to the complications observed today," according the FDA statement.
The report also noted that there was no established link between the silicon gel-filled breast implants and breast cancer, reproductive problems or connective tissue disease, but added that additional studies enrolling more women and running longer than the existing studies are needed to explore the possibility.
