Transvaginal Mesh Device Recall

The Transvaginal Mesh (TVM) recall story is slightly different than most other defective product tales because the US Food and Drug Administration did not have to enforce a recall. That is because the primary manufacturers of the products quickly saw the potential for serious liability and voluntarily pulled their products, or recalled their TVM implants, from the market after preliminary FDA warnings were issued and then backed up by further research.

As of 2011, the government agency reported it had received thousands of reports of serious complications associated with TVM implants, including issues of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional turmoil and distress as well as damage to many personal relationships, referred to in legal terms as loss of consortium.

If you have suffered serious injury as a result of a transvaginal mesh device, you should speak with a product liability attorney who is familiar with the recall of dangerous products and drugs.

Only a qualified lawyer can answer your specific questions regarding your potential claim. But for answers to your specific questions, you will need to retain the services of personal injury lawyer.

Since the 2011 warnings, the FDA has proposed a reclassification of surgical mesh for transvaginal pelvic organ prolapse (POP) repair, inviting public comment on the matter until July 30, 2014.

FDA Warnings and TVM Implants

Prior to the 2011 warnings, the FDA convened an advisory committee to investigate the thousands of complaints it had received regarding TVM devices. The panel heard testimony by many frustrated medical professionals who directly witnessed – and attempted to treat – damage caused by the mesh.

Despite this, the agency has not issued a full recall. However, the reclassification – if it is enforced – will require extremely rigorous premarket testing before widespread distribution of any future surgical mesh product.

There remains dissent among the ranks of the US medical community regarding the possible ban on all surgical mesh devices. The American Urogynecologic Society (AUGS) does not favor a total ban of the mesh product, while many doctors have said they refuse to use the product for POP and similar conditions. Urogynecologists specialize in treating pelvic floor disorders and incontinence.

Consumer Advocacy Group Calls for TVM Ban

Conversely, Public Citizen’s Health Research Group has urged the FDA to recommend a universal recall of the device. According to his group, mesh poses “significant risks to the public.” It should be noted that Public Citizen petitioned the FDA to ban the device in 2011. In its petition, the group pointed to the lack of testing before mesh implants were released to the public and urged the FDA to require more stringent tests regarding future mesh products – including in humans.

TVM Manufacturers Face Mounting Lawsuits

There are several significant legal challenges currently underway against six major mesh manufacturers. More than 22,000 individuals are included in these actions, which involve the following defendants:

  • American Medical Systems
  • Boston Scientific
  • C.R. Bard
  • Johnson & Johnson’s Ethicon subsidiary,
  • Coloplast Corp.
  • Cook Medical

All of these cases were consolidated into six separate Multidistrict Litigations (MDLs), or one per defendant. Preliminary hearings are still being heard before a single U.S. District Court in West Virginia. Thousands TVM lawsuits are also being filed in state courts. Recently, a number of state cases against the manufacturer of the Mentor ObTape vaginal sling were consolidated into a separate MDL in a U.S. District Court in Georgia.

Experienced TVM Injury Lawyers Can Help

Women who have filed TVM injury lawsuits have alleged that the manufacturers had a legal duty to insure the safety and effectiveness of their pelvic mesh products but instead provided patients with false and/or misleading information about the products’ effectiveness and safety. If you have suffered from the harmful side effects linked to transvaginal mesh devices, you have the right to pursue civil justice.

Price Benowitz LLP can help you retain the services of a lawyer who has extensive experience in litigating claims related to TVM injuries and side effects. Call the firm today for a free, initial consultation.