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 Settlement Involving AMS
Transvaginal Mesh Lawsuit: AMC Pays Millions To Settle Litigations Prior to Trial
American Medical Systems (AMS) has reportedly agreed to pay $55 million to settle a number of transvaginal mesh implant lawsuits filed against it. The disclosure made public on June 20, 2013, during an SEC filing by Endo Health Solutions, Inc. – the parent company of AMS – indicates that it had settled only a few of thousands of lawsuits awaiting trial. AMS faces close to 8,000 transvaginal mesh implant lawsuits, including class actions, filed in various U.S. courts.
A leader in offering pelvic health solutions, AMS manufactures Perigee and Apogee vault suspension systems, BioArc and In-Fast Ultrs vaginal mesh implants, Elevate prolapsed repair systems, and other bladder neck support systems. It also produces and distributes SPARC, MiniArc, and Monarc pelvic slings. Its mesh devices have been subject of intense speculation following widespread complaints linking them to early erosion, infections, and range of complications in users. While more than 6,000 transvaginal mesh implant lawsuits have been centralized for pre- trial consolidation at a West Virginia federal court, hundreds more are being filed following extensive media focus on side effects of mesh implants.
Transvaginal Mesh Lawsuit: What Went Wrong With Mesh Implants
Prescribed for the treatment of pelvic prolapse and urinary inconsistency, transvaginal mesh implants lead to a number of health complications in users. The FDA MedWatch system received thousands of adverse event reports after the federal regulator made its first public acknowledgement about large-scale problems with these mesh implants. This was followed by a spate of studies and research reports that put spotlight on complications caused by side effects of transvaginal mesh implants.
In 2008, the FDA initiated a comprehensive review of all transvaginal mesh implants done since 1996. The interim report presented in 2010 highlighted mesh erosion, vaginal problems, inflammation and infections, device failure, pelvic organ perforations, and a number of other complications. Following huge public outcry over the 510(k) fast track approval process that allows products to skip rigorous testing, the FDA has ordered for comprehensive safety assessment of all transvaginal mesh implants available in the market.
According to the latest research findings of Russian scholars, vaginal mesh implants should not be used until there is significant pelvic prolapse without any alternative treatment. The paper made public at Milan European Association of Urology in March 2013 listed as many as 30 serious injuries that these mesh implants can cause. Researchers interviewed 600 mesh users and found that over 22 percent of them have one or more of these listed injuries.
A Mayo Clinic study first reported in the American Journal of Obstetrics and Gynecology in September 2012 highlighted the risk of pelvic fibrosis, high morbidity rate, and uterus damage due to the transvaginal mesh implants. While use of polypropylene, a plastic, in these devices is reported to cause pelvic fibrosis, mesh implant or removal surgeries put users at the risk of uterus damage. Two years ago, a report in the Obstetrics & Gynecology journal had claimed that transvaginal mesh implants did not offer any significant benefit compared to available treatment options.
Earlier in December 2011, an advisory issued by the Committee on Gynecologic Practice asked U.S.-based gynecologists, urologists, and obstetricians to reconsider prescribing transvaginal mesh implants because of high rate of premature failure and complications associated with these devices.
Transvaginal Mesh Litigation
More than 20,000 transvaginal mesh implant lawsuits have been filed in the United States. West Virginia Southern District Court Judge Joseph R. Goodwin has been entrusted with six separate multidistrict litigations by the Federal MDL Panel. It includes 6,028 AMS transvaginal mesh lawsuits, 5,763 Ethicon Gynecare mesh lawsuits filed against Johnson & Johnson, 3,557 Boston Scientific transvaginal mesh lawsuits, 2,938 Bard transvaginal mesh lawsuits, and 320 litigations against Coloplast. While the majority of these litigations are product liability lawsuits filed against manufacturers for selling defective products, a few of these have also questioned the fast track approval of these products by the FDA through its 510(k) process without trial.
In February 2012, a transvaginal mesh lawsuit filed in a New Jersey state court against Johnson & Johnson led to $11.1 million in damages awarded to a South Dakota woman. The plaintiff suffered from complications after the Ethicon Gynecare vaginal mesh she had perforated her vagina and caused severe infections. She underwent 18 surgeries because the injuries caused. The first of Bard Avaulta mesh implant lawsuit also resulted in $5.5 million compensation for a California woman in July 2012.
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.