Update: Despite studies on silicone breast implants that have fallen short of FDA goals, the General and Plastic Surgery Devices advisory panel of the Food and Drug Administration made the decision late yesterday to allow the implants to stay on the market, ignoring lobbying from consumer groups to pull the product entirely.
Dr. William Maisel, deputy director of the FDA’s devices division said at the conclusion to the meeting that, “We believe implants are safe and effective and should remain on the market.”
The scarcity of follow-up data after implantation is cause for concern. One manufacturer cited only a 25 percent rate of follow-up among their recipients, far less than the requisite 90+ percent initially set by the FDA. Regulators will consider setting up a registry for implant patients, given that there has been such poor post-surgical follow-up and patients are not voluntarily completing the annual 27-page questionnaire and undergoing MRI testing for possible implant rupture.
The panel has said they believe that “it’s good idea to have a conversation about a breast implant registry.” They mentioned the possibility of linking participation by women to the warranty on their devices, or to their surgeons' certification.
The two manufacturers of silicone breast implants fail to conduct necessary follow-up studies, as required by the FDA, assuring that the devices are safe. A recent meeting of the FDA’s General and Plastic Surgery Devices advisory panel discussed the follow-up safety studies for silicone implants that were provided by both Mentor and Allergan, and found evidence sorely lacking and falling far short of the agency’s goals.
After ending a fourteen-year moratorium on silicone implants with the approval of two new models produced by Mentor and Allergan, the FDA ordered both companies to perform follow-up studies to provide evidence of long-term safety of the devices, as little was in existence at the time of their approval.
The ten-year studies involve 80,000 patients, of which half received Mentor’s model, with the remaining half having received the Allergan brand. A number of these studies are not scheduled to end until 2016.
Other FDA-required follow-up by the makers of the breast implants included a study of the effectiveness of the devices among thousands of past recipients, a device failure study of implants that necessitated removal, a comprehensive patient survey, focus groups, and a able study of a new group of recipients post-FDA approval, in addition to a randomly selected survey of 50 plastic surgeons on decisions made regarding breast implants.
However, Allergan has thus far achieved a follow-up rate of about a 60 percent of the 93 percent goal over a two-year period, while Mentor has only followed up with a mere 25 percent of implant recipients in the same time period.
Among women who have received the breast implants, follow-up rates for those opting for the implants for cosmetic reasons are significantly lower than those who received the devices during reconstructive surgery following a mastectomy.
According to William Adams, an investigator at the Allergan trials, and an associate plastic surgery professor at University of Texas Southwestern Medical Center in Dallas, said that obtaining follow-up data from many implant recipients has proven to be difficult, and does not allow studies to get a truly representative sample of women. He explained, “The ones who don’t come back are doing well,” and added that only those who are unhappy with the devices tend to come back for follow-up visits, participate in focus groups, and fill out surveys.
One scientist from Allergan noted that the reasoning behind low follow-up rates is two-fold. First, women who choose to receive the implants for cosmetic reasons do not see the need for their participation in the follow-up, and those having implants after a mastectomy want to put the past behind them.
Consumer Groups Want Implants Pulled from Market – Page 2
Data presented by the FDA showed that the majority most women who receive breast implants report being happy with their implants after eight and ten years. However, the FDA recommends that women receiving implants have a breast MRI three years after undergoing the implant procedure, and then regularly at two-year intervals thereafter to screen for ruptures, whether or not they experience problems with the devices.
Even so, rates of the screening MRIs remain low. This may be due in part to the fact that some insurance companies do not provide coverage for the MRIs when no medical problem is evident, and women are unwilling to pay the cost for the screening.
Two consumer advocate groups, the National Organization for Women Foundation and the National Research Center for Women and Families, pressed for the FDA’s removal of the implants from the market.
Jan Erickson, of the National Organization for Women Foundation said, “It’s unacceptable that many patients Mentor and Allergan were supposed to track were lost.” She then added, “Mentor’s approval should be rescinded right away, and Allergan should be required to conduct further studies.”
However, the agency said the issue of product removal was not under consideration during the meeting, and the advisory panel will make its final recommendations on post-approval studies at the meetings end.
According to the American Society of Plastic Surgeons, nearly 400,000 breast enlargement or reconstruction procedures were performed in the United States in 2010, including both silicone and saline implants.vnpharma.net
Soure: HealthNews
