Consumer groups asked the FDA to recall Johnson & Johnson’s (NYSE: JNJ) silicone breast implants over concerns that they haven’t collected postmarket data on the devices as promised.
JNJ’s Mentor division and Allergan Inc. (NYSE:AGN) won FDA clearance for silicone breast implants in 2006 on the condition that they would collect safety data on 40,000 patients for 10 years.
Allergan has collected data for 60 percent of its patients for two years, while JNJ has data on 21 percent of patients for three years.
Representatives from both companies said they may have “overreached” with their studies by attempting to follow so many patients and requiring them to fill out 27-page surveys each year.
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JNJ also shifted their study participation from mandatory for all breast implant patients to voluntary participation.
“It’s unacceptable that many patients Mentor and Allergan were supposed to track were lost,” National Organization for Women Foundation spokesperson Jan Erickson said. “Mentor’s approval should be rescinded right away. And Allergan should be required to conduct further studies.”
The FDA released updated information about gel-filled breast implants in June, warning that they often cause complications that need additional surgery or removal, drawing from data provided by JNJ and Allergan who essentially control the breast implant market.
“The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications,” the report noted, adding that 20 percent of implants used for augmentation will require removal within 10 years, as will half of implants used for reconstruction.
The revamped breast implant is safer than the last generation, which was pulled off the market in 1992 over fears of leakage, but the silicon prosthetics still come with risks, the FDA warned.
Common complications include hardened skin around the implant, wrinkled or ruptured implants, scarring, pain and infection. Some patients complained of these side effects at this week’s advisory panel.
The June 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.
Consumer groups argued that the FDA needs to take a stronger hand in forcing the companies to adhere to the rules and provide postmarket study data.
“We believe that this agency has to walk the walk,” National Physicians Alliance executive director Jean Silver-Isenstadt told Reuters. “Its mission is to protect patients, and when it sets criteria for approval, that should be real. When the agency begins to look more like window-dressing (for companies), that will shake the faith of physicians and patients.”
The FDA panel is set to make recommendations on postmarket studies later today.