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Tens of thousands of women receive a transvaginal mesh (TVM) device each and every year from numerous suppliers: American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson. Thousands of women have been injured through no fault of their own, including vaginal erosion, pain, urinary problems, bleeding, infection and more. Our attorneys are representing women in all fifty states and Canada who have been injured. For a free case evaluation, call 1-800-632-1404.
FDA panel supports reclassifying surgical mesh used for pelvic organ Prolapse.
As attorneys who are representing women nationally that have experienced horrific injuries from the use of a transvaginal mesh device from several manufacturers, including Boston Scientific, Bard and Johnson & Johnson, we wanted to advise the public that the FDA is supporting the reclassification of mesh products.
Johnson & Johnson (J&J) and C.R. Bard Inc. have to carry more clinical studies and present more safety data on the transvaginal mesh used to treat prolapsed pelvic organ, the FDA said on Friday. The reason? While transvaginal mesh is known to give support to the weakened muscle of the pelvic organ to hold it in the right place, the FDA stated that the mesh produced by J&J and C.R. Bard lacked enough data to prove its efficiency and safety.
Until the FDA’s annoumcement, the pelvic organ prolapse (POP) surgical mesh products were in the Class II medical devices in the 501(k) approval process. As per the regulation, manufacturers were required to show that the meshes were substantially equivalent to an existing device on the market. No preclinical test of the product was required.
We applaud the efforts of the FDA to increase the classification level of TVM devices from class II to class III in order to ensure the safety and effectiveness of these devices for the general public.
To further explain why, we would provide the following to our readers, and request that you should contact us today for a free case evaluation if you are suffering from a transvaginal mesh product.
The Problem
In 2008, the FDA first released concerns about the safety of transvaginal placement of mesh. From 2008 to 2010, the FDA received three to five times as many adverse reports associated with mesh used for pelvic organ prolapse repair than what agency received from 2005 to 2007 (nearly 1,000 reports of adverse events were received from 2005-2007).
Many of these patients complain because of erosion or contraction of the mesh material (which has been described as being of a similar material as Rubbermaid storage containers). The erosion leads to bleeding, severe pelvic pain, painful (or impossible) sexual performance and a recurrence of urinary problems.
In July 2011, the Food and Drug Administration (FDA) issued an update related to what it called ‘serious complications’ related to the use of vaginal mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is now known that complications linked to transvaginal placement of surgical mesh in SUI and POP patients are not rare and can require multiple surgeries to correct problems related to the use of surgical mesh. In fact, the FDA now says that additional surgeries may actually not be able to repair damage caused by implantation of the mesh.
In other words, the side effects of the mesh placement may be permanent. These complications from transvaginal placement of surgical mesh include:
- -Erosion of the implanted mesh
- -Infection and/or bleeding
- -Pain, including pain during sexual intercourse
- -Problems with organs near the implantation site
Helping You
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.
If you received a transvaginal mesh / sling and have been injured, you may be entitled to monetary compensation. Problems include pain, inability to have intercourse,bleeding, mesh growth into the body, mesh erosion, and more. Problems could be irreversible. Please fill out the form to the right or call us so that we can provide you with forms to evaluate your potential case immediately.
We are accepting case evaluations nationwide and in Canada, as well. Please do not hesitate or delay in contacating TVM / TVT Sling and transvaginal mesh attorneys :
CALL: 1-800-632-1404
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