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, C.R. Bard, Boston Scientific, Coloplast, and Johnson & Johnson / Ethicon. 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.
TVM Injuries: Benefits vs. Risks
Transvaginal Mesh Lawsuit: Adverse Events Undermine Benefits
Surgical transvaginal mesh implant fails to provide any substantial benefit and is no way better than non-mesh and other conventional pelvic prolapse repair treatments, according to the January 2013 public health alert by the FDA. Mesh implants, to make matters worse, result in severe complications, including vaginal infections, bladder perforations, postoperative difficulties, and urinary problems. While at least one in every five users is likely to suffer from transvaginal mesh side effect injuries, premature mesh erosion requires users to undergo surgical removal or other treatments, which costs them much more than the original procedure. A South Dakota woman underwent 18 surgeries after having suffered several injuries from Gynecare Prolift transvaginal mesh implant.
FDA Device Approval Process in Question
A number of transvaginal mesh litigations have questioned the FDA approval of these medical devices through the 510(k) process that saves products from mandatory clinical trials. Most of the 99 mesh and sling implants subject to product liability lawsuits are allowed through this controversial approval process without the need to undergo rigorous testing. The end result is that thousands of women suffer from permanent and life-threatening injuries. A 2011 report in the Archives of Internal Medicine highlighted 21 products, including mesh implants, which had been recalled between 2005 and 2010 but approved without adequate prior testing.
FDA Acknowledges Transvaginal Mesh Injuries
The FDA warned about transvaginal mesh injuries for the first time in 2008 following a revision of all pelvic prolapse surgical implants done since 1996. The regulator admitted that it was aware of thousands of mesh erosion, pelvic perforation, vaginal infection, and postoperative complication complaints linked to vaginal mesh implants. A more stringent FDA warning was issued in 2011 following analysis of all vaginal mesh implants in the last 15 years, which rejected claims by manufacturers that mesh implant could lead to additional benefits over non-mesh treatments. Meanwhile, the FDA received over 2,800 transvaginal mesh complaints on it MedWatch program.
Highlighting of significant side effect injuries associated with mesh implants by consumer groups and research institutions forced the FDA to ask manufacturers in January 2012 to conduct detail post-marketing safety studies about their products. The directive covered 11 slings and 88 mesh implants. Johnson & Johnson, afraid of negative fallout, recalled its Ethicon Gynecare transvaginal mesh, which was subject to over 2,000 product liability lawsuits in June 2012.
Research Studies on Transvaginal Mesh Injuries
- March 2013: A Russian research paper presented at the Milan European Association of Urology conference warned of higher risk of complications caused by surgical transvaginal mesh implants. Scholars found that at least 22 percent of over 600 mesh users interviewed suffered one or more mesh-linked, intra-operative, and post operative injuries. They listed over 30 types of serious complications caused by mesh devices and advised those without significant pelvic prolapse or young at age against using these implants.
- September 2012: A joint study conducted by Spectrum Health and the Mayo Clinic, reported in the American Journal of Obstetrics and Gynecology, warned of potential uterus damage risk caused by transvaginal mesh removal surgery. Scholars discovered that mesh implants made of polypropylene could result in pelvic fibrosis. Their proximity to the uterus results in transection of this vital organ during the excision process. The study put the morbidity rate caused by mesh implants to as high as 14.5 percent.
- December 2011: The Committee on Gynecologic Practice, the foremost body of all gynecologists, urologists, and obstetricians in the country, warned all its members of the risk of complications caused by transvaginal mesh implants. It recommended restrictions on mesh prescribing these mesh implants, citing higher rate of failure.
- July 2011: Public Citizen listed transvaginal mesh implants of all types available in the United States on its “Do Not Use” register. It began a nationwide campaign to force FDA to reassess safety of these implants. A month later, a European study claimed that vaginal mesh implants had an unusual high reoperation rate pegged at 12 percent. It noted serious infections, mesh erosion, and life-altering complications as the most important causes of secondary surgeries.
- October 2010: A report in the Obstetrics & Gynecology journal criticized transvaginal mesh implants for their high erosion rate and dismissed its efficacy for pelvic prolapse treatment. It found that one in every six users faces the risk of premature mesh erosion and that these implants did not improve quality of lives of users as claimed by manufacturers.
If you have experienced an injury after a vaginal mesh procedure, contact our attorneys at 1-800-632-1404 today. 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
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.