Medical implant manufactures face many Lawsuits
In what has become a big concern for the manufacturers of a surgical implant known as transvaginal surgical mesh, some 500 lawsuits have been filed against them in a mass tort action. This is because a growing number of women who have received the implant, as part of a surgical procedure to repair the onset of Sudden Urinary Incontinence (SUI) or Pelvic Organ Prolapse (POP), have been suffering symptoms attributed to the malfunction of the implant itself. Erosion is the most common problem, where the tissue has worn away and the mesh starts protruding. There are other symptoms of distress including excessive bleeding, pain, vaginal infections, incontinence and bowel disorders and discomfort during sex.
The mesh is currently only used in about a quarter of the operations, nevertheless there have been upward of 75,000 implants of this mesh in 2010 in the USA. The mesh has in fact been used in operations for 30 years, having first been used in the repair of hernias, where strengthening of the stomach lining was required. It was subsequently developed as a stiffener for implant behind the vaginal wall in these tricky surgical procedures. The use of them is popular with the medical fraternity as the reoccurrence of the pathology they were treating is reduced and recuperation is a lot faster.
There was a safety warning from the FDA in October 2008 but at that stage the adverse effects were rated as rare. However there are growing numbers of patients who previously had this treatment and are now finding that the device is giving them problems as mentioned above. Over 2400 reports were received by the FDA during 2009 and 2010 for both POP and SUI procedures. This is exacerbated by the fact that the device is a permanent implant. Vaginal tissue has grown through it and it becomes firmly embedded in the body. Removal is both extremely tricky and will not necessarily cure the new problems. This has led to a far more serious safety warning published by the FDA on 13 July 2011.
The mass tort action contends that the medical device is at fault and should not be causing this distress. Thus the manufacturer is liable for an inherent failure in the device. This is particularly stringent in the case of medical devices. Anyone who is suffering Vaginal Mesh Injury should immediately see their doctor. If there is evidence that the implant is causing a problem it is suggested that a consultation with a Tranvaginal Mesh Attorney is scheduled.
In the interim on 9 September 2011 the FDA had a meeting with the manufacturers. Thus far they have agreed that more clinical trials be undertaken, although they claim that extensive trials have already been done and that the device is “safe”. They have further agreed that the packaging be altered to draw attention to the risks involved in its use.
The product is currently rated as of moderate risk and requires the doctor to advise the patient before undertaking an implant of the dangers involved. It also advises special training in the use and installation of these devices.
The final outcome of this meeting will be published once all representations have been submitted.