Pelvic Mesh / Mass Torts

Mass torts are cases that involve a large number of claims associated with a single product or event and are marked by a commonality of important factual and legal issues.  Mass torts are most prevalent in medical device and pharmaceutical litigation.

Transvaginal Mesh Lawsuits

Partner Timothy S. Tomasik is leading the Clifford Law Offices team that is investigating cases in which women who have had transvaginal mesh /sling products (also known as TVM or Pelvic Mesh) surgically implanted are now suffering from serious complications, including pelvic organ prolapse (POP).  Over the past several years, there have been several thousand injuries reported to the Food and Drug Administration (FDA) following the implantation of TVM.  Clifford Law Offices is currently interviewing women who have suffered complications involving TVM from numerous manufacturers including Bard, Inc., Johnson & Johnson, Boston Scientific, American Medical Systems, Inc. (AMS), and Ethicon. 

Surgical Implantation of Transvaginal Pelvic Mesh

Pelvic Mesh is being surgically implanted in patients who suffer from pelvic organ prolapse (POP) or Stress Urinary Incontinence (SUI).   POP is a condition where the muscular floor that supports pelvic organs drops due to childbirth, surgery, or with age.  POP often results in the bladder, bowel and other organs to fall causing severe pelvic pain, incontinence, erosion of vaginal tissue, bleeding and perforations of the bowel, bladder or blood vessels.

Over the past decade, multiple medical device manufacturers aggressively marketed and promoted the installation of mesh to treat POP.  The mesh device, and the surgical techniques marketed by the manufacturers to install mesh, were designed to replace the traditional methods of surgical and non-surgical repair routinely employed by doctors.  Surgeons using this device permanently implant synthetic mesh patches transvaginally, and anchor the synthetic material to the muscles and ligaments surrounding the pelvic floor to support the pelvic organs above.

Tragically, many women who have received Pelvic Mesh implants have suffered serious injuries and side effects.  The FDA has recently stated that mesh kits of all brands have a higher than expected failure rate – “serious adverse events are NOT rare…” The FDA has described some injuries as serious and permanent. (PDF)  The injuries often include the erosion of the mesh into the surrounding tissue, including the bladder, bowel and the extrusion exposure of the mesh into the vaginal wall resulting in painful intercourse, bleeding, serious infection and death. Many patients require surgery to address the injuries. Unfortunately, since the mesh is intended to be permanent, surgeons are often unable to remove the mesh despite multiple surgeries. In September, 2011, the FDA issued a recall of certain pelvic mesh devices.  The FDA formulated an advisory panel that has conducted a preliminary investigation and recommended that mesh manufacturers conduct more stringent pre-market testing of vaginal mesh products and the reclassification of mesh devices to a Class III device– the highest risk category for any medical device currently on the market.

Pelvic Mesh Litigation

If you have experienced a serious complication due to pelvic mesh, please contact pelvic mesh attorney Timothy S. Tomasik by email or call (312) 899-9090 and Clifford Law Offices will discuss a possible pelvic mesh lawsuit with you or someone who you are trying to help.

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