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.
Ethicon’s Gynecare TVM Implant
Gynecare Transvaginal Mesh Implant Injuries: The Must Know Facts
Johnson & Johnson subsidiary Ethicon recalled its Proflit, Prosima, MTM, and vaginal mesh implant products sold under the Gynecare brand in June 2012 following large number of consumer complaints. The products introduced in the 1990s and 2000s are found to be causing serious side effect injuries to users, including urinary problems, need for additional surgeries, pelvic prolapsed reoccurrence, and severe pain. Gynecare vaginal mesh implants, which have 70 percent market share in the United States, are named in about 1,000 lawsuits filed in various federal and state courts.
FDA Warning on Transvaginal Mesh Implants
The recall of Gynecare vaginal mesh implants was expected following large number of complaints to the FDA. These implants accounted for 1,500 of 2,900 transvaginal mesh injury complaints received through the MedWatch adverse reporting system. The important adverse side effects include inflammation, pelvic extrusions, repeated need for surgeries, and irreversible vaginal pain. In June 2011, a public health alert issued by the federal health regulator warned consumers about serious complications caused by side effects of all mesh implants, including those sold under the Gynecare brand.
In January 2012, the FDA ordered all manufacturers, including Johnson & Johnson, to put their vaginal mesh implants for clinical trials and safety assessment tests. All implant makers were required to carry on new post-marketing studies and report the findings to the regulator. The manufacturer removed Gynecare vaginal mesh implants from the market saying that the retesting a commercially unviable option.
Other Gynecare Vaginal Mesh Implant Complaints
- • A study published in the American Journal of Obstetrics and Gynecology in August 2010 claimed that Gynecare Prolift vaginal mesh implants have a high erosion rate of 15.6 percent. This negated the claims that the implant was superior to alternative pelvic organ prolapse repair.
- • Consumer organization Public Citizen put Gynecare vaginal mesh implants on its “Do Not Use” in July 2011 saying that the devices “needlessly expose patients to serious, life-altering complications.”
- • In August 2011, another study published in the American Journal of Obstetrics and Gynecology on the findings of European researchers reported that at least 12 percent of Gynecare Prolift transvaginal mesh implant users underwent reoperation due to complications cause by the device side effects.
- • Two reports published by News Inferno and Bloomberg in October 2011 disclosed that Johnson & Johnson introduced its Prolift transvaginal mesh implants three years before it was allowed by the FDA. In August 2007, the FDA wrote to Johnson & Johnson to stop selling of the devices which went unheeded.
- • In early 2012, Representative Henry Waxman of California supported by many House Democrats called for a Congressional hearing on serious adverse effects of transvaginal mesh implants.
Gynecare Vaginal Mesh Implant Injuries and Side Effects
The transvaginal mesh implants are linked to a range of health complications in women, including many irreversible impacts. The major mesh implant injuries reported include the following.
- Pelvic pain and discomfort leading to additional surgeries
- Mesh erosion making the implant visible on vagina surface
- Perforation of pelvic organs
- Chronic Infection
- Vaginal pain and bleeding
- Inflammation
- Pain during intercourse
- Recurrence pelvic organ prolapsed
- Urinary problems
Gynecare Vaginal Mesh Implant Lawsuits
More than 1,000 Gynecare vaginal mesh implant lawsuits have been filed in the United States. Over 400 lawsuits are only awaiting trial in New Jersey. The plaintiffs claim that the failure of the manufacturer to report side effects caused them to suffer from complications. All federal lawsuits are consolidated at a federal court in Charleston, West Virginia, following the MDL panel decision.
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.