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.
We are honored to have two women on staff ready and willing to discuss the facts of your case with you as often as needed.
Cases Continue To Be Filed – Contact Us Today
It has been alleged that transvaginal surgical mesh went on the market without having to undergo the appropriate clinical testing and gained clearance through the FDA’s 510(k) process. At this point in time, thousands of women have been injured and filed claims in state and federal courts across the country because of the 510(k) approval process.
In 1976, the U.S. Congress passed medical device amendments which defined the various steps medical device manufacturers needed to take to obtain clearance to sell products. This has become known over time as the 510(k) process, which allows manufacturers to sell hundreds of medical devices that have never been clinically tested for safety or effectiveness. In such a process, the FDA categorizes devices into three classes based upon potential risks and the ability of post-market controls to manage them.
Class II medical devices are considered low to moderate risk and manufacturers are only required to notify the FDA 90 days before they market them. Approximately 90% of medical devices authorized for sale by the FDA go to the 510(k) process. Transvaginal surgical mesh is one such product that entered the commercial market via the 510(k) process. Transvaginal surgical mesh is a class II device.
We must turn back the clock to the 1990’s when medical doctors first began using surgical mesh to treat stress urinary incontinence (SUI) in women. This condition generally begins from a child birthing process in which a woman’s pelvic muscles become weakened and involuntarily leak urine. It is estimated that over 500,000 women every year undergo some type of surgery for either pelvic organ prolapse (POP) or SUI.
It is somewhat interesting that transvaginal mesh was approved for sale by comparing it to mesh that was used to treat abdominal wall defects in hernias. One of the first products on the market was the Boston Scientific ProteGen Mesh, which the FDA approved in 1996. In 1998, Johnson and Johnson’s Gynecare TVT Mesh was approved through the 510(k) process claiming it was substantially equivalent to ProteGen.
In 1999, ProteGen was removed from the market after it was associated with a high number of complications including erosion of vaginal tissue. Despite the fact that ProteGen was removed from the market, Boston Scientific and other manufacturers including Coloplast, Johnson and Johnson, American Medical Systems, Inc. (AMS), and C.R. Bard, Inc. continued to market, manufacture, and sell transvaginal mesh devices, TVM devices, TVT devices, and transvaginal slings based on the original ProteGen design.
To date there have been thousands of reports of post-surgical complications due to transvaginal mesh devices. Such patients must often undergo multiple surgeries to remove the mesh and repair damage which includes erosion of the mesh device into the tissues and muscles of the human body. This particular area of the human body is far more problematic for erosion because of movement in the area in which the device is implanted, unlike the abdominal cavity.
In 2008, the FDA first warned healthcare providers about potential problems concerning the use of transvaginal mesh in European SUI procedures. The FDA reported that “over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair [pelvic organ prolapse] and [stress urinary incontinence].”
In 2011, the United States Food and Drug Administration (FDA) issued an update which formally recognized that the problems associated with transvaginal mesh were much more serious than initially reported. “Serious complications associated with surgical mesh for transvaginal repair of [pelvic organ prolapse] are not rare.” The agency continued that “it is not clear that transvaginal [pelvic organ prolapse] repair with mesh is more effective than traditional than non-mesh in all patients with [this condition] and it may expose patients to greater risk.”
There have been nearly 3,000 adverse events associated with transvaginal surgical mesh. To date, thousands of lawsuits have been filed across the country, many of which are consolidated in the United States District Court for the Southern District of West Virginia before a multi-district litigation (MDL) proceeding before Judge Joseph Goodwin. More than 300 cases have been filed against C.R. Bard, and more than 150 lawsuits have been filed against others. In all, more than 1,000 cases are pending across the country.
Our team of attorneys are currently representing more than 100 women who claim to have suffered similar injuries as a result of using pelvic mesh products. Please continue reading for more help.
Do You Qualify for a Transvaginal Mesh Lawsuit?
Recently, the public has become aware of serious health complications suffered by women after undergoing surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI) with transvaginal mesh devices. According to the U.S. Food & Drug Administration (FDA), between January 2008 and December 2010, there were nearly 3,000 adverse event reports involving transvaginal mesh devices. Specifically, there were 1,503 reports of complications involving POP repair and 1,371 reports linked to surgery for SUI. Our team of lawyers are representing women who experienced both complications.
Side effects reported in transvaginal mesh recipients include:
- Infections
- Internal bleeding
- Vaginal scar tissue
- Vaginal wall narrowing
- Painful urination
- Fistulas
- Mesh shrinkage
- Mesh migration
- Urinary problems
- Punctures to the bladder, blood vessels, bowels or other organs in the lower abdomen
- Mesh erosion into the vagina, bladder, intestines, and uterus
- Pain
- Painful sexual intercourse for both partners
- Recurrence of incontinence
- Recurrence of both POP and SUI, or both
Numerous lawsuits have been filed over these complications, in part because studies have shown that transvaginal mesh offers no real benefit over safer, more traditional methods of treatment. Making matters worse, in many cases the POP or SUI the implant was supposed to fix in the first place returns. Transvaginal mesh manufacturers took advantage of the FDA’s highly criticized 510(k) approval process, which allows medical devices to be sold on the market without ever being safety tested in humans. Now, thousands of innocent women are paying the price.
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, Johnson & Johnson’s Ethicon, and Coloplast.
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, Coloplast, 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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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.