Surgical mesh is a medical device used in women to treat pelvic organ prolapse (POP), bladder prolapse, and other similar conditions. Surgical mesh resembles woven fabric and can be implanted vaginally or through the abdomen. Thousands of women have undergone urogynecologic procedures using surgical mesh with the hope that the medical device would offer an improved solution to treating POP, urinary incontinence and other similar disorders. However, many women have suffered painful, serious complications as a result of a transvaginal mesh device.
2008 FDA Warning
Several years ago, the Food and Drug Administration (FDA) expressed concern about the complications associated with transvaginal placement of surgical mesh and urged physicians to obtain specialized training in performing surgical mesh procedures. According to a 2008 FDA Public Health Notification, from 2005 to 2008, more than 1,000 reports of complications stemming from transvaginal mesh had been received. The most common type of complications reported, included vaginal epithelium (tissue) erosion, infection, urinary problems, pain, vaginal scarring, bowel and bladder perforation, and recurrence of POP. Despite the large number of reports received, the FDA stated in the warning that complications were rare.
2011 FDA Warning Update
After reviewing updated analysis on the adverse side effects linked with transvaginal mesh devices, the FDA issued an update on the 2008 warning stating, “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” In the July 2011 update, the FDA also stated that it did not believe transvaginal repair with surgical mesh was more effective than traditional procedures used to treat POP and other similar disorders. In fact, the FDA stated transvaginal mesh could pose a greater risk to the patient.
As mentioned above, one of the complications associated with transvaginal placement of mesh is bowel and bladder perforation. Bowel and bladder perforation (abnormal holes in the wall of the bladder or bowel organ) is a serious complication caused by displaced surgical mesh. When displaced, the mesh can “puncture” the walls of the bowel or bladder causing abdominal inflammation, bleeding, pain, difficulty urinating, and in some cases, death.
Compensation for Serious Transvaginal Mesh Complications
If you suffered serious complications after undergoing a transvaginal mesh procedure, please do not hesitate to phone an attorney at the law firm of Estey Bomberger. We can discuss the details of your case privately and will quickly determine your eligibility to file a personal injury claim. You may be entitled to compensation for secondary surgeries, doctor visits, medicine, lost wages and earnings, loss of quality of life, and pain and suffering, so call our office today. We offer free consultations and do not require any fees until we have recovered compensation on your behalf.