The Use of Pelvic Mesh in Vaginal Surgery:
At some point during their lives, millions of women will suffer from an involuntary loss of urine during a physical activity known as Stress Urinary Incontinence (SUI), or the movement of a pelvic organ which pushes against the walls of the vagina, known as Pelvic Organ Prolapse (POP). These conditions are often caused by birth and pregnancy, hysterectomy, or simply through aging. For some, these conditions are resolved in time on their own. Others seek relief through various approaches, including a surgical approach involving the implantation of pelvic mesh. Pelvic mesh, which can be implanted vaginally or abdominally, is used to support weakened pelvic muscles and vaginal tissues for those who suffer from SUI and POP.
Rising Complications Associated with Pelvic Mesh
While pelvic mesh has provided relief to some, various manufacturers of pelvic mesh, including American Medical Systems, Boston Scientific, C.R. Bard, and Ethicon (Johnson & Johnson), are under scrutiny for numerous health concerns associated with pelvic mesh products which are implanted transvaginally. Reports of alarming complications associated with transvaginal mesh and slings are rapidly rising, including reports of severe pain, bleeding, scarring, disfigurement, erosion of mesh through the vagina, shrinkage and contraction of mesh, infection, bladder or bowel penetration, and the need for multiple revision surgeries.
Between 2005 and 2007, the FDA received numerous reports of complications with pelvic mesh. In October of 2008, the FDA issued a Public Health Warning concerning serious complications associated with vaginal mesh to treat SUI and POP. However, complications continued to soar at a fivefold increase between 2008 and 2010, prompting the FDA to issue a 2011 update to its previous warning. In the 2011 update, the FDA warned that serious complications associated with surgical mesh during transvaginal repair of POP are not rare, in contrast to what was previously reported in 2008. The FDA also cautioned that it is not clear POP repair with vaginal mesh is more effective than non-mesh repair, and it may expose patients to greater risk. The FDA stated it would continue to evaluate the effects of surgical mesh to repair SUI.
At this time, neither the FDA nor any of the vaginal mesh manufacturers have issued a formal recall of the vaginal mesh products in the US. However, in early 2012 the FDA announced further efforts to discern the efficacy and safety of these products. The FDA is now requiring vaginal mesh manufacturers to participate in post market clinical and surveillance studies, and to report their findings to the FDA. Since this announcement, at least two manufacturers of vaginal mesh products, C.R. Bard and Johnson & Johnson, have begun quietly pulling these products off their shelves.
How O'Mara and Padilla Can Help: Call 858-480-6182 Today
If you are suffering from complications related to transvaginal mesh, you are not alone. Hundreds of pelvic mesh litigations are now being filed nationwide, seeking justice for the devastation these harmful medical devices have imposed on unwitting patients. If you have been harmed by the use of transvaginal mesh we welcome your call for a confidential pelvic mesh litigation case evaluation. All transvaginal mesh cases are handled on a contingency fee basis; as such you will incur no out of pocket costs or attorney fees.