TVM Mesh MDLs Further Centralized for Trans Vaginal Litigation

Charleston, WVPrimarily due to commonalities involving the science and issues surrounding problems with TVT sling and other transvaginal mesh products, various Multi District Litigations (MDL) have been recently consolidated before a single judge whom advocates say is uniquely qualified to deal with the portfolio.

Much has been written in recent months about transvaginal mesh devices, also known as TVM mesh. The latter is a surgical mesh used to treat and control Pelvic Organ Prolapse (POP), a condition typified by the weakening of muscles associated with internal organs that begin to descend into the uterus. Stress Urinary Incontinence (SUI), is a related condition affecting mostly older women and is a byproduct of childbirth.

A transvaginal sling, also known as a TVT sling, is employed to mitigate urine leakage in women suffering from SUI. Conversely, TVM mesh has been commonly used in recent years to treat POP. Surgical mesh is inserted arthroscopically through a small incision and deployed within the body. While surgical mesh is not new—the product has been used for decades to treat abdominal hernias—the introduction of TVM mesh and TVT sling has proven problematic in large measure, say critics, due to the fast-tracking of the approval process. The US Food and Drug Administration (FDA) allows manufacturers of new products similar to those already on the market to dispense with the need for pre-market clinical testing.

Hundreds of women have reported pain and suffering after TVM mesh has protruded through the vaginal wall, triggering infections and painful intercourse with their partners, not to mention a negative impact on their daily activities.

For many, a transvaginal mesh lawsuit has ensued.

To that end, as of February 7, hundreds of such lawsuits already consolidated into various MDLs have been further consolidated into one, and will now be heard in one federal district court presided over by a single judge.

As reported in PRWEB (2/9/12), the US Judicial Panel on Multidistrict Litigation (JPML) established three new multidistrict litigation cases: American Medical Systems, Inc. (MDL No. 2325), Boston Scientific Corp. (MDL No. 2326) and Ethicon, Inc./Johnson & Johnson (MDL No. 2327).

Further, those three MDLs will be centralized before Chief Judge Joseph R. Goodwin in the US District Court for the Southern District of West Virginia. Advocates of the move stress that centralizing all transvaginal mesh complication cases into one court will speed up the process, and is appropriate given the commonality of factual issues surrounding defects that are viewed as similar.

The consolidation of lawsuits alleging TVT side effects among other transvaginal issues will eliminate duplicative discovery and inject efficiencies into the entire process. Judge Goodwin is described as being completely familiar with the issues surrounding transvaginal sling and TVM mesh products, and is uniquely qualified to preside over the portfolio.

The FDA, for its part, has the TVM and TVT portfolio of products (involving no fewer than 33 manufacturers) under the microscope, and has signaled a change in policy that may re-classify TVM mesh to require pre-market clinical testing. The regulator has already signaled that in its view, TVM mesh and TVT sling may not be the best way to treat POP and SUI.

In July of last year, the FDA said it had received no fewer than 2,874 reports of TVM and TVT complication in the two years between 2008 and 2010. Erosion of the vaginal mesh and protrusion through the vaginal wall were commonly reported.

Some transvaginal mesh lawsuits have been brought by the husbands of TVM and/or TVT patients, alleging injury and loss of consortium following the protrusion of sharp edges through the vaginal wall. With lawsuits moving forward, and with the FDA now questioning the safety and effectiveness of the TVT sling procedure and others involving trans vaginal mesh over more traditional methods of repair, there is little doubt the TVM landscape may look different in subsequent years.