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 Injury Possible with Bard TVM Device
Transvaginal Mesh Lawsuit: Records Show Plastics Used in Bard Mesh Implants Unhealthy
Thousands of women using C.R. Bard transvaginal mesh implants for pelvic prolapse treatment and stress urinary incontinence may face the prospects of harmful side effects caused by unhealthy plastics used in them. Court documents unsealed recently show that vaginal mesh implants by the company contain plastic elements that are considered risky for human use. Bard is facing over 3,000 transvaginal mesh lawsuits, including 250 in a West Virginia district court. The first Bard vaginal mesh lawsuit resulted in $5.5 million compensation to a 53-year-old Californian woman.
Documents released prior to the schedule trial of Bard vaginal mesh lawsuits at the West Virginia south district court highlight that the company procured plastics from Chevron Phillips Chemical for the manufacturing of surgical mesh implants at its Davol unit. The supplier brands its products with a label warning prohibiting use of its resin-based plastic in implants meant for human use. According to Bloomberg News, a number of emails exchanged internally by Bard executives between 2004 and 2007, which was accessed during the discovery process, reported the use of plastics unsuitable for humans in mesh implants. One of the emails dated March 2004 urges others to keep it secret from suppliers that harmful plastics for humans were being used for medical applications.
According to a September 2012 report in the American Journal of Obstetrics and Gynecology, polypropylene elements in transvaginal mesh implants put users at the risk of pelvic fibrosis. Bard’s Avaulta transvaginal mesh implants have been named in thousands of lawsuits for causing pelvic erosion, vaginal infection, and other health problems. While about 550 mesh implant lawsuits are awaiting trial at an Atlantic County court of New Jersey, over 2,500 litigations have been consolidated at a West Virginia south federal court. The first bellwether trial is set to start on July 8, 2013.
Transvaginal Mesh Lawsuit: Problem With Mesh Implants
According to the Federal Panel on MDL, about 20,000 transvaginal lawsuits have been filed in various U.S. courts. All major manufactures, including AMS, Bard, Boston Scientific, Cook Medical, Coloplast, and Johnson & Johnson, face product liability claims. All 88 vaginal mesh and 11 sling implants manufactured by 33 companies are subject to comprehensive review following reports of a large number of side effects. The plaintiffs claim to have suffered from the following types of injuries from these implants:
- Mesh shrinkage and erosion
- Premature device failure
- Vaginal infection, scarring, pain, bleeding, and shortening
- Damage to pelvic organs
- Perforation of bladder, uterus, and pelvic organs
- Sepsis and surgical injuries
- Revision surgery
- Pelvic inflammations and urinary problems
In 2008, the FDA first admitted the risk of serious side effects associated with vaginal mesh implants. A study mandated by it, covering all those who had these implants since 1996, brought to light the harmful impacts of these implants. This, coupled with about 3,000 complaints on MedWatch adverse event reporting system, forced the FDA to issue a public health warning, highlighting threats posed by transvaginal mesh implants.
Transvaginal Mesh Lawsuit: Studies Question Faulty Products
The Obstetrics & Gynecology journal published a research study in October 2010 questioning the efficacy of transvaginal mesh implants. Researchers discovered that at least one in six consumers using these mesh devices face the prospect of premature mesh erosion and poor quality of life. In July 2011, consumer watchdog began a campaign to ban all these mesh implants and petitioned the FDA demanding their withdrawal.
A European study made public in September 2011 claimed that 12 percent reoperation rate made transvaginal mesh implants a risk to use. The report highlighted the threat of mesh erosion, infections, and complications among the major reasons for secondary surgeries in consumers using these implants. Two months later, the apex organization of all U.S. gynecologists, urologists, and obstetricians, The Committee on Gynecologic Practice, asked its members to restrict prescribing transvaginal mesh implants to patients, considering the premature failure and infection risks.
The American Journal of Obstetrics and Gynecology published a report in September 2012 that warned of pelvic fibrosis and uterus damage risk posed by transvaginal mesh implants. The study jointly carried out by the Mayo Clinic and Spectrum Health found that these devices could lead to morbidity conditions in 15 percent of users and their excision process could damage vital internal organs.
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.