August 31, 2011
Groups Want J&J Silicone Implants Off The Market
Consumers advocates claim that Johnson & Johnson has not been able to provide enough long-term safety data regarding their silicone breast implants.
However, the FDA said the issue of product removal was not under consideration during the meeting.
The National Organization for Women Foundation and the National Research Center for Women and Families are the groups who wish Johnson and Johnson's product to be taken off the market.
The FDA approved the product in 2006 on condition that both companies follow 40,000 women for 10 years to look at safety issues.
Allergan, which sells the product alongside Johnson & Johnson, has collected preliminary two-year data for 60 percent of participants, while Mentor has collected three-year data for just 21 percent.
"It's unacceptable that many patients Mentor and Allergan were supposed to track were lost," Jan Erickson, of the National Organization for Women Foundation, said during the two-day event.
"Mentor's approval should be rescinded right away. And Allergan should be required to conduct further studies."
According to the American Society of Plastic Surgeons, there were almost 400,000 breast enlargement or reconstruction procedures in the U.S. in 2010.
The FDA said in June that the risks of breast implants are well understood, after looking at the companies' results as well as reports of negative events and scientific literature.
The agency had banned silicone implants for most U.S. women in 1992 after some said the devices leaked and made them chronically ill.
Patients complained during the meeting on Tuesday that side effects like rupturing or hardening of the device ensued after treatment.
Company representatives said the studies had "over reached" by trying to keep track of so many patients.
Reuters reports that Jean Silver-Isenstadt, executive director of the National Physicians Alliance, said the FDA needed to show its commitment to enforcing post-approval studies.
"We believe that this agency has to walk the walk," she 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."
On the Net:
- Johnson & Johnson
- National Organization for Women Foundation
- National Research Center for Women and Families
- American Society of Plastic Surgeons
- National Physicians Alliance