Transvaginal Mesh Warnings Added to Labels
July 5, 2016

A comprehensive study about the TVM implant

The FDA defines the transvaginal mesh as a medical device made of “porous absorbable or non-absorbable synthetic material or absorbable biologic material” It is inserted in the patient’s vaginal region to treat symptoms of POP or urinary incontinence (SUI). The meshes are inserted through a woman’s vagina, instead of an open surgery that cuts into her body. The procedure grew in popularity given its ease and faster recovery scope.

 

Although the meshes were approved for the treatment of pelvic organ prolapse in 2002 by the FDA, there were hundreds of negative reports about these meshes. Some of the complications, when left undiagnosed caused life threatening situations. The bladder mesh lawsuit filed stated how the devices were wrongly described and marketed by the manufacturers.

What are the Injuries?

The injuries that women are accused to have suffered from the mesh implant are debilitating in nature and could have been prevented had people had the proper information.

The edges of the sling can cut through the skin during or after the implantation. This leads to infection or even causing punctures in the bladder, bowel, and uterus. The commonly reported side effects of such complication is incontinence, inability to walk, extreme pain during intercourse, back pain, UTI and more.

Studies showed around 30 percent of women who underwent mesh surgery for POP had to go for a revision surgery which is equally and often more difficult than the first attempt.

Claims in lawsuit

With increased number of reports about the complications, bladder mesh lawsuits against the transvaginal mesh manufacturers are rising. Recently, over 17,000 women injured by the vaginal mesh patches have filed lawsuits against the mesh makers. In a majority of these lawsuits, victims have called out the manufacturer of the bladder sling used in their operation, not the surgeon that performed the operation. A woman injured by the faulty transvaginal mesh can file a lawsuit without having to sue her physician.

The mesh makers are accused of the following in any bladder mesh lawsuit:

  • They failed to do any proper clinical research about the side effects of the mesh implant
  • The makers did not warn in its label enough for the patients to be aware of the possible side effects of mesh implant
  • The makers did not used the promised mesh quality or materials, thus breaching the safety of public health
  • They went on misrepresenting and branding the products as a safe and effective alternative to the existing treatment methods of POP and SUI even though there were thousands of negative reports about the mesh implant

FDA and its announcement

The FDA has re-classified the vaginal mesh used in the treatment of POP as a high-risk device given the large number of health risks associated with them. The classification, however, does not apply to the transvaginal mesh used in the repair of SUI. As a patient, if you are aware of the possible complications of transvaginal mesh implant, you can look for the other safer alternatives such as biological mesh.

If you are a woman over 40 and are experiencing injury and physical complications from defective mesh implant, get in touch with the experts of VMSettlements.net. Find out if you are eligible for financial compensation if you have suffered from intense abdominal pain, difficulty in passing urine or discomfort during sexual intercourse.

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