Vaginal mesh manufacturers fighting reclassification of their products
Following the FDA safety warning on 13 July 2011, in which the FDA raised serious concern over the adverse effects occurring in the use of Vaginal Mesh implants which were no longer regarded as “rare”, the manufacturers met with the FDA in Maryland on 9 September 2011.
The background to all of this was the use of a surgical mesh implant to assist in the repair and support of certain organs in the pelvic floor of women suffering from a pelvic organ prolapse. The POP is a common problem amongst many women of advancing age who have had children and or a hysterectomy, although POP is not limited to that group only and may be suffered by ladies who are overweight or suffer from an incessant cough or some other illnesses.
Surgery is only undertaken in the most severe cases as the operation is a delicate one and the reoccurrence rate is between 30 and 35%. Nevertheless in 2010 some 350,000 operations were performed in the US for repair of POP in 2010 and in about a quarter of these cases (about 75,000) was this vaginal mesh woven behind the vaginal wall to give support to the sagging organs.
Vaginal mesh was developed from a product that had been in use for 30 years, mostly for the repair of hernias in the strengthening of the stomach lining. When it started being developed for use in the repair of POP and Sudden Urinary Incontinence (SUI), the manufacturers had it licensed under an FDA procedure 510(k) for moderate risk products. This allowed it to be fast tracked as it was similar or identical to another product already in use and approved.
Prior to a 2008 FDA safety warning a few cases of adverse effects of Vaginal Mesh were reported. These were largely non-specific and were regarded as rare. During 2009 and 2010 there was a spike where over 2000 cases of adverse effects being reported, which led to the 13 July Warning. The principal problem reported is “erosion” where the tissue wears away and the mesh protrudes into the Vagina. This is or can be accompanied by pain, discomfort during sex, infection, bleeding and incontinence.
There are now over 500 Lawsuits pending against the manufacturers. In the California Vaginal Mesh Lawsuit a number of sufferers are coming forward who claim that their life has been ruined by the pain and discomfort caused by the reaction to the device.
At the Maryland meeting the manufacturers are proposing that the tape remain classified as “moderate risk” and that they will institute further field trials. This they said they will do but they have already performed extensive field trials and that these showed the product as being safe and beneficial to most patients when used by a proficient surgeon trained in the installation.
The manufacturers have also agreed to change the labeling on the product to highlight the risks. They wish to avoid it being reclassified as “High Risk” as that would mean the FDA would specify the tests and be in control of the results. The bureaucracy involved would slow the development right down they claimed.
The final decision by the FDA will not be made for some time now as they consider all the submissions already made and others that they have called for.
In the meantime there is a California Vaginal Mesh Attorney ready and willing to consult with anyone who is experiencing pain and discomfort relating to a vaginal mesh implant from anytime in the last 10 years.