FDA Issues Warning on Transvaginal Mesh Devices

FREE CASE EVALUATION: 1-800-632-1404

If you are reading this page, you are likely suffering from pain after a prior surgery implanting a transvaginal mesh device / TVT / TVM system and sling.You may have been diagnosed with stress urinary incontinence or pelvic organ prolapse. Whatever the reason, you are likely in pain today, and we believe we can help you. If you would like to speak to a TVT lawyer, TVM lawyer or transvaginal mesh lawyer, please call us today for a free case evaluation.

BREAKING NEWS: Federal regulators are warning that women who receive vaginal mesh to treat pelvic organ prolapse face a serious risk of complications and health problems, and the devices appear to provide no benefits over other methods of treating the pelvic organ prolapse.  The FDA issued a vaginal mesh safety communication on July 13, indicating that surgical mesh placed in the vagina to treat pelvic organ prolapse (POP) can erode through the vaginal tissue causing pain, infection, bleeding, pain during intercourse and urinary problems. There is also a risk of organ perforation during the surgical procedure to install a vaginal mesh, the agency stated. PLEASE READ THE FSA WARNING HERE.

The FDA first issued a warning about vaginal mesh complications in October 2008, indicating that, at that time, more than 1,000 people had reported experiencing problems with products made by at least nine different manufacturers. In addition, a study published earlier this year found a high risk of problems with all vaginal mesh implants.

The warning comes after a number of vaginal mesh lawsuits have been filed against several manufacturers by women who claim to have been injured by pelvic support systems. Our Firm represents women across the country who have received and been injured by TVM devices.

In our opinion, the FDA is already making clear statements that it is doubtful that the benefits of vaginal mesh implants outweigh the risks. FDA warned that transvaginal placement of surgical mesh carried the highest risk. There are other surgical techniques to address pelvic organ prolapse that do not involve the use of a surgical mesh or involve placement of the mesh in another part of the abdomen.

You may have experienced mesh erosion, bleeding, urinary infections, vaginal scarring, pain during sexual intercourse, failure to conduct sexual intercourse and more. A physician may have tried to remove the mesh and been unable to do so. You may be in excruciating pain, and need help. We are offering free case evaluations to the general public across the United States and Canada. Manufacturers we consider include American Medical Systems, Bard, Boston Scientific, Ethicon, Gynecare, and Johnson & Johnson.

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