TVM Lawsuit Center

Have you suffered debilitating side effects as a result of transvaginal mesh (TVM) implant? If so, it’s possible that you have the legal right to file a personal injury claim against the product’s manufacturer for any harms and losses you have suffered as a result of the dangerous device. A number of lawsuits have already been filed by women all over the country.

For more information on this topic, please refer to the following TVM lawsuit center page. For answers to your specific questions, you should speak with a dedicated TVM lawyer. Or, learn more how a lawyer can help.

TVM is a synthetic product or type of surgical mesh that has been used to support failing pelvic floor muscles and reproductive organs. The mesh is surgically implanted and secured to the ligaments that support these atrophied abdominal muscles.

TVM has been used to treat Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). Both conditions are primarily caused by insufficient strength of the pelvic floor muscles and typically occur in older women who have borne children.

What is Pelvic Organ Prolapse and Stress Urinary Incontinence?

Pelvic Organ Prolapse (POP) is a condition that occurs when the muscles and tissue around the pelvic organs weaken or stretch. This causes the organs to fall from their rightful place. Stress Urinary Incontinence (SUI) is a condition referred to as “leaky bladder” for many years.  SUI occurs when there is leakage of urine during moments of physical activity, such as coughing, sneezing, or laughing.

Among the women who suffer from urinary incontinence, about 50 percent suffer the effects of stress-induced incontinence, according to the US National Library of Medicine. TVM surgery was approved by the FDA for the treatment of POP and SUI procedures more than a decade ago.

Many different manufacturers have produced TVM devices, though the four companies with the greatest market share were American Medical Systems (AMS), Johnson & Johnson’s Ethicon unit, Boston Scientific, and C.R. Bard.

FDA Warnings Regarding TVM

In 2008, the FDA released its first public health notification regarding possible complications associated with transvaginal mesh. The most frequently cited problems were:

  • Erosion through vaginal epithelium – the membranes that support and cushion the vaginal walls;
  • Infection;
  • Urinary problems – including incontinence (involuntary urination) and painful urination;
  • General Pain in the lower abdominal area;
  • Recurrence of prolapse – the inadequate support of abdominal organs and the condition that required the TVM implant;
  • Decrease of quality of life due to vaginal scarring, discomfort, and pain, including Dyspareunia (painful sexual intercourse).

In 2011, the FDA issued a warning that changed the outlook of TVM symptoms from the “rare” category to “more common.”  From January 1, 2008 through December 31, 2010, the FDA received an additional 2,874 reports of TVM complications (1,503 related to POP and 1,371 related to SUI).  The FDA stated “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair.”

They continued to note that the risks of using the device may outweigh the benefits gained, though the agency still refrained from issuing a recall. By this time, however, the bulk of the manufacturers were already pulling their products from the market. The FDA’s also noted the symptom of mesh contraction (shrinkage) that was not previously disclosed in the 2008 notification.

Earlier this year, the FDA began taking public comment on its bid to reclassify TVM as a Class III medical device, which would require extensive testing before the products could be released in the marketplace.

TVM Mass Torts and Lawsuits

Very few defective product lawsuits end up with one single plaintiff and one negligent defendant.  Most often, plaintiffs are combined because many people tend to be injured in similar ways when using the same product. In such cases there are two general options, both of which must be approved by a judge who is presiding over an injury case. They can become either traditional class action lawsuits, or mass torts.

A traditional class action involves many victims banding together in a single cause of action and represented by a single attorney (or law firm). If they are successful they share in the single award, or lump sum.

Mass Torts, though they are more complicated to execute, allow for a plaintiff to pursue their own settlement or court-ordered award. Like class actions, multiple client claims can be joined in one multidistrict litigation (MDL) complaint for the purposes of pretrial proceedings. Each claim, however, retains its identity and individuality when it comes to the actual trial and potential awards.

Deciding on which option will best serve your needs requires the skill and knowledge of a dedicated TVM lawyer. You need someone who can not only manage your case effectively, but who can successfully work with attorneys all over the country for a common cause.

Mass tort plaintiff attorneys work together to investigate, pool evidence, and create trial strategies that benefit the entire group of plaintiffs. Some mass torts that are currently being litigated (with some still being enjoined by new clients) in Federal Court for the Southern District of West Virginia include:

  • Defendant: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (“MDL No. 2325”);
  • Defendant: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation (“MDL No. 2326);
  • Defendant : C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation (“MDL No. 2187”)
  • Defendant: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation (“MDL No. 2327”)

A Seasoned TVM Lawyer Can Help

Tens of thousands of women throughout the country, through their attorneys, are in the midst of legal action to hold the makers of dangerous TVM products responsible for their injuries. Do your injuries merit a TVM lawsuit?

Only a qualified attorney can answer that question, though we can tell you that virtually all TVM manufacturers have pulled their products from the market due to the knowledge that the devices have proved to be a danger to thousands of patients.

Serious side effects associated with TVM include chronic urinary leakage, extremely painful sex, recurrence of prolapse, scarring and shrinkage of the vaginal area, and emotional distress. Part of this is due to the fact that many TVM organ damage events cannot be reversed. Not all victims of TVM-related side effects experience obvious symptoms.

Many, however, suffer with debilitating pain and injuries and have required extensive corrective surgeries, which has made it difficult for them to progress with their careers and care for themselves and their families.

If you have received a TVM implant and have suffered any of the ill effects associated with the product, you should retain the services of a product liability attorney who has extensive experience, and success, in litigating such cases.

Price Benowitz LLP does not handle these cases, but we can help you find a well-qualified attorney who will explain all of the legal options to you and who will help you determine your best court of action. Call to learn more.