Under pressure from consumer safety advocates and product liability attorneys, the Food and Drug Administration is likely to soon limit access to surgical mesh devices because of the high risk of personal injury and complications resulting from the use of these. The Food and Drug Administration has confirmed that it will soon review the safety of the devices, which are used to treat pelvic organ prolapse in women.In this condition, the uterus and other organs shift from their position, and protrude through the body.The condition is frequently seen in women after childbirth.A surgical mesh device is used to keep the protruding organs in place.These devices are implanted transvaginally.
However, the Food and Drug Administration has been aware of complaints involving complications in women who had been implanted with surgical mesh products, for a while now.According to the Food and Drug Administration, between January 2008 and December 2010, it received more than 1,500 complaints of complications associated with the use of surgical mesh products.In July, the agency issued a safety warning about the products.Most of the complaints alleged chronic pain after the insertion of the surgical mesh.Women have also reported complaints about painful sexual intercourse.
What has seemed really outrageous to Atlanta product liability attorneys is that many women, who have had these surgical mesh products implanted and now face chronic and consistent pain, could have been treated even without the use of these devices.Doctors now believe that an unknown number of women may have had surgical mesh produces implanted to treat pelvic organ prolapse, when there are noninvasive techniques that can help treat the condition. In fact, the Food and Drug Administration believes that the use of surgical mesh product exposes patients to more severe injury risks, compared to traditional non-mesh repairs.The increased risk from the use of the surgical mesh does not translate into higher benefits for these patients.The Food and Drug Administration says that it has not seen any evidence to indicate that the use of the surgical mesh treats the condition any better than non-mesh procedures.
Consumer safety groups have been vocal about appealing to the Food And Drug Administrationto recall these products from the market.These devices are currently classified as moderate risk, but consumer groups want the products to be banned from the market altogether.These products were approved through the Food and Drug Administration’s fast track 510 (k) approval process that is often used to approve medical devices that are similar to those already in the market.This controversial approval process has been used to approve hundreds of devices over the years, and is widely favored by medical device makers, because it allows them to get their devices approved without going through the usual procedures under traditional approval methods.
The Atlanta product liability lawyers at the Katz Law Firm represent victims who have been injured through the use of defective products across Georgia.