Vaginal Mesh Manufacturers on the carpet
Following the FDA’s safety warning on 13 July in which they published a health warning stating that there are safety issues with transvaginal mesh which were not “rare” and of “continuing genuine” anxiety, the manufacturers met with the FDA on 9 September.
In the July Warning the FDA further stated that the application of mesh exposed patients to a greater risk of adverse outcomes than those who were treated by stitching alone. (This conclusion was gleaned from a review of published literature since 1996). They had already issued a prior indication in October 2008 of the increase in adverse results with vaginal mesh implants. At that stage it was still considered rare as they had received a total of just over a 1000 reports between 2005 and 2008. But they said they would continue to monitor.
Over the following 2 years the FDA received over 2400 reports (a fivefold increases filed linking adverse effects to the mesh device. Ostensibly 1500 reports of adverse outcomes were for POP repair and 1000+/- for SUI surgery. The Implantation of mesh is permanent and excision is not necessarily feasible or will solve the complications.
At the meeting on September 9 the manufacturers accepted that further safety studies were needed and agreed to change the labeling to warn of potential risks. They proposed that new versions undergo clinical trials and existing implants be followed up. They nevertheless did not accept that this was a high risk procedure.
The FDA can approve the transvaginal mesh as “moderate-risk” devices and require additional safety studies or labeling changes. No decision from the meeting has yet been published and is only likely to be made once all representations have be submitted.
In the meantime there are a growing number of women who, over the last 10 years have had vaginal mesh implants. Over 75,000 women received these implants in 2011 alone.
It is perfectly possible for this mesh to start presenting problems, like erosion, where the tissue wears away and the mesh starts protruding into the vagina, many years after the implant. A Vaginal Mesh Attorney is available to consult on any legal complications that now arise.
While they are unable to resolve the medical problems that may be arising, if the manufacturers are guilty of a tortuous act they will be held accountable and compensation will be extracted. This compensation will go some way to addressing the future possible medical bills that may be upcoming.
Anyone not suffering from adverse reactions but who has concerns is urged to consult with the health professional that treated her in the first place.
Was the stuff used to manufacture the mesh adequately researched and tested prior to release on the market? Were adverse consequences that arose during that inquiry adequately reported? Is there a “tort” (a duty of care not to sell a faulty health device in this instance) on the part of the manufacturers. These are questions that should be answered as the manufacturers have received claims from up to 500 cases of patients claiming that they had suffered a Vaginal Mesh Injury.