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.

Changes Could Be On Horizon for 510(k) Products

Many women who have suffered from bladder prolapse, pelvic prolapse and other related complications have had transvaginal mesh implanted to treat the problem. Atransvaginal mesh is a surgical mesh made from polyester or polypropylene and feels like a woven fabric and is implanted in the vagina. It reinforces the vaginal wall and creates what is at times referred to as a pelvic sling or baldder sling.

Transvaginal mesh (TVM) and transvaginal tape slings (TVT) are currently classified under FDA guidelines as 510(k) products. When a 510(k) product is introduced for sale to the general public, the manufacturer is not required to complete a full testing protocol if the device were a class III pre-market approval device.  This may change in the future.

The Hill (12/29, Pecquet) reported in its “Healthwatch” blog that the Food and Drug Administration “unveiled draft guidance Wednesday on how it reviews applications for low-risk medical devices.” Noting that the agency “has been working with industry and patient advocacy groups to overhaul its so-called 510(k) program, which medical device makers complain has grown too complicated and uncertain,” the account adds that the draft guidance “is not final and is not currently in effect, but gives stakeholders a chance to comment” by April 26 as the FDA begins work on its final guidance.

Our team of attorneys is reviewing case evaluations for women across the country who have received TVM and TVT products from manufactures such as C.R. Bard, Avaulta, Boston Scientific, and Johnson & Johnson’s Ethicon.

If you need help from a transvaginal mesh device injury, call us today for help.

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

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.