In light of the many adverse events seen among women who have undergone transvaginal mesh surgeries in the past few years, the FDA is considering more stringent controls over approval of the device. Surgeons currently perform as many as 300,000 pelvic organ prolapse and stress urinary incontinence surgeries every year, a large portion of those using mesh in the procedure.
Early this year, DePuy issued their recall for the ASR XL Acetabular System sold in the United States. Doctors began recommending revision surgery to those of their patients who reported pain or an overall failure of the DePuy hip implant.
In the eyes of the average American consumer, U.S. Food and Drug Administration (FDA) approval signifies that a medical device has been thoroughly tested and has been found to be safe and effective.
In the wake of DePuy Orthopedics, Inc.’s recall of defective ASR hip implant devices, patients and their physicians have been searching for ways to mediate the potential health risks involved. With complications ranging from dislocation of the implant components and bone fractures at the hip, to metal poisoning, or metallosis, finding an accessible, effective treatment is imperative.
The pharmaceutical giant, Johnson & Johnson, has been given a 2012 earnings forecast which is below the previous estimates present by financial analysts due to the number of DePuy hip replacements which were recalled. In fact, recent reports state Johnson & Johnson takes $3 billion charge for hip recall.