FREE CASE EVALUATION: 1-800-632-1404
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 Recommends Mesh Be Classified as “High Risk”
As a firm representing women who receive transvaginal mesh devices, we were highly interested in a recent article by Bloomberg News. Bloomberg News (9/1, Edney) reported that “A Food and Drug Administration staff recommendation” says that transvaginally implanted surgical mesh “products fail to lead to better outcomes than non-mesh repair and should be reclassified as posing a high risk to patients,” and the mesh makers “may have to submit added safety data to regulators to keep their products on the market.” Bloomberg News adds that a “change in risk classification may take several years to complete and the agency said it could consider a grace period for makers of products on the market to submit data to comply with a more stringent review.”
The article goes into detail on how transvaginal mesh products were re-classified under the 510(k) approval process, which requires far less testing than a Class III medical device under Pre-Market Approval rules and regulations.
The article also went on to note what has already been reported to many times on this blog: that the agency received 1,503 reports of complications associated with the material from January 2008 to December 2010 when used for pelvic organ prolapse, the FDA said in a safety warning July 13. The devices were used in 75,000 transvaginal surgeries last year, according to the FDA.
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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