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.
The Risks of Transvaginal Mesh (TVM)
Transvaginal Mesh Side Effect Injuries: Research Studies
Transvaginal mesh implants do not offer any significant advantage over non-mesh implants and carry considerable higher risk of side effect injuries. Independent research studies have warned of irreversible and multiple complications associated with these mesh implants. The FDA, based on thousands of transvaginal mesh implant injury complaints it received, has also admitted the possibility of serious complications caused by these devices designed to treat pelvic organ prolapse. About 4,000 litigations have been filed in different US courts following transvaginal mesh implant side effects that left many with debilitating injuries and permanent sufferings.
Vaginal Mesh Implant Research Reports
- In October 2010, Obstetrics & Gynecology journal published a research report that questioned the efficacy of transvaginal mesh implants for prolapse repairs. The study found that there was no significance improvement in quality of lives for those using mesh implants over non-mesh users. It also found 15.6 percent erosion rate among vaginal mesh implants that put down any superior benefit these devices claim to offer.
- In July 2011, consumer group Public Citizen put transvaginal mesh implants of more than 30 manufacturers on its “Do Not Use.” A month later, it led a nationwide petition to the FDA to ban these devices and save users from serious, life-altering complications.
- A European research paper published in August 2011 warned that transvaginal mesh implants could lead to higher reoperation risk. It found that as many as 12 percent of mesh implant users had to undergo reoperation following infections, complications, and mesh erosion.
- A study by the Millennium Research Group and published in January 2012 highlighted concern among healthcare professionals over prescribing transvaginal mesh implants for pelvic floor repair. The foremost reason given was increasing number of reports about mesh-linked injuries and early erosion rate.
- In December 2011, the Committee on Gynecologic Practice, the apex body of obstetricians, gynecologists, and urogynecologists, advised doctors to restrict prescribing transvaginal mesh following growing number of complaints about its side effects and failures.
- Earlier this month, a transvaginal mesh warning was put out by the Committee on Gynecologic Practice, which includes members from the American College of Obstetricians and Gynecologists and the American Urogynecologic Society.
FDA and Transvaginal Mesh Implants
In January 2012, the FDA ordered 33 transvaginal mesh implant producers to have comprehensive safety assessments of their products. The federal regulator asked manufacturers to carry out 99 post-marketing studies in total covering 88 surgical mesh implants and 11 mini-slings implanted through incisions. The order came after sever criticism of FDA approval of these mesh implants through its 510(k) process that allows fast-track permission without rigorous testing.
In July 2011, the FDA warned about potential problems, such as infections, perforations, and serious complications, linked to transvaginal mesh implants. It admitted that its review of mesh implants between 1996 and 2010 did not show any significant benefit that these mesh devices had over alternative treatments available.
There were at least 1,503 transvaginal mesh adverse event complaints reported on FDA MedWatch system between 2008 and 2010. The numbers swelled after the FDA admitted in 2008 to be aware reports of pelvic perforation, serious infections, additional multiple surgeries, vaginal shrinkage, and other complications caused by these medical products. The Atlantic County Superior Court awarded $11 million to a 46-year-old South Dakota woman in February 2013 to compensate her for injuries she suffered following transvaginal mesh implant. Linda Gross underwent 18 surgeries after the mesh implant side effects caused severe health complications impacting her life and career.
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.