Get Help With Your Transvaginal Mesh Claim
Millions of women have received a transvaginal mesh implant or mesh sling to help repair pelvic organ prolapse (POP) or stress urinary incontinence (SUI). POP occurs when the organs in the pelvis slide out of place, and SUI is the involuntary release of urine during activities such as sneezing or coughing. These conditions can severely impact quality of life.
These devices, however, have been linked to a high rate of serious complications. The personal injury attorneys at Parker Waichman LLP are investigating injuries associated with transvaginal or pelvic mesh devices, and we offer free case evaluations to those who have been harmed by these implants. Contact us today to speak with a top transvaginal mesh lawyer about your legal rights.
What Is Transvaginal Mesh?
Transvaginal mesh is a mesh implant meant to help correct POP and SUI by providing the pelvic organs and muscles with extra support.
Dangers of Transvaginal Mesh: Serious Complications and Side Effects
The U.S. Food and Drug Administration has found that the most common side effects and complications associated with transvaginal mesh include:
- Mesh erosion through the vagina (also called exposure, extrusion or protrusion)
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
In 2016, the FDA reclassified transvaginal mesh as a Class III high-risk medical device, and in April 2019, the FDA ordered a halt to the sale of these devices. Now, thousands of women are suing their manufacturers. A qualified transvaginal mesh attorney can help you get the compensation you deserve for the harm caused by these dangerous medical devices.
Defendants in Transvaginal Mesh Lawsuits
Pelvic mesh lawsuits have been filed on behalf of women around the country against several manufacturers of transvaginal mesh (TVM) and sling devices, including:
- American Medical Systems: Sold under the names Elevate, Perigee, and Apogee
- Boston Scientific: Sold under the names Advantage Transvaginal Mid-Urethral Sling System, Pinnacle Posterior Pelvic Floor Repair Kit, Obtryx Transobturator Mid-Urethral Sling System, Polyform Synthetic Mesh, Prefyx Mid U Mesh Sling System, Prefyx PPS System, and Uphold Vaginal Support System
- C.R. Bard Inc.: Sold under the names Avaulta, Pelvisoft BioMesh, Pelivicol Acellular Collagen Matrix, Pelvitext, and Pelvilace
- Johnson & Johnson/Ethicon: Sold under the names Gynecare, Gynemesh, Gynecare Prolift, Gynecare Prolift + M, Gynecare Prosima, and Gynecare TVT
Types of Compensation From a Transvaginal Mesh Lawsuit
Victims of vaginal mesh implant and sling failures, who choose an experienced lawyer for their transvaginal mesh lawsuit, may be compensated for injuries and losses including:
- Out-of-pocket medical, surgical, and hospital expenses
- Emotional distress
- Loss of ability to have sexual relations/loss of consortium on behalf of spouse
- Loss of quality of life
- Lost wages
- Pain and suffering
Timeline of Regulatory Action on Transvaginal Mesh Devices
- July 13, 2011: The FDA said in a Safety Communication that complications associated with transvaginal mesh implants were “not rare” and that there was no conclusive evidence showing that transvaginal mesh was more effective than non-mesh repairs in all patients with POP. The FDA said it had received 2,874 new reports of complications linked to transvaginal mesh between January 2008 and December 2010. Studies reviewed by the agency showed that about 10 percent of women who had a transvaginal mesh implant experienced erosion (meaning the mesh cut through their body’s tissues) within 12 months of surgery; more than half of them needed additional surgery to remove the mesh. In some cases, even multiple surgeries did not resolve transvaginal mesh complications.
- Aug. 25, 2011: The watchdog group Public Citizen, founded by Ralph Nader, stated that the FDA should recall transvaginal mesh products due to safety concerns and painful side effects.
- Aug. 31, 2011: The FDA stated in an Executive Summary that it “believes that vaginal placement of surgical mesh for pelvic organ prolapse (POP) repair inherently introduces risks of complications that are unique to the mesh itself.”
- September 2011: During a meeting convened by the FDA, a majority of the obstetrics and gynecology medical device advisory panel agreed that the safety, effectiveness, and benefits of transvaginal mesh devices in POP repair were not well-established.
- April 2014: The FDA issued two proposed orders meant to address the health risks often seen when surgical mesh is used in the transvaginal repair of POP. Under these proposals, the mesh would be reclassified from a Class II device (moderate risk) to Class III (high risk). In addition, the makers of these devices would be required to submit pre-market approval (PMA) applications to the FDA proving their safety and effectiveness rather than receiving clearance through the FDA’s less stringent Section 510(k) approval route, which allows a device to be approved with no clinical trials if it’s significantly similar to a previously approved device.
- Jan. 5, 2016: The FDA did reclassify transvaginal mesh as a Class III medical device. Manufacturers were given a 2018 deadline to submit PMA applications. Instead, nearly all of them stopped selling these devices; only two, Boston Scientific and Coloplast, attempted to get approval for their mesh.
- April 16, 2019: The FDA denies approval to Boston Scientific and Coloplast and orders them to discontinue sales of these products.
Transvaginal Mesh Lawsuit Update: Where Do Legal Claims Stand?
Numerous lawsuits have been filed against the makers of these dangerous medical devices, with thousands of cases still pending. More than 100,000 cases have been consolidated into multi-district litigation against their manufacturers, and millions of dollars in compensation have been awarded so far through either a transvaginal mesh settlement or jury verdict.
|American Medical Systems||2325|
|Ethicon (Johnson & Johnson)||2327|
|Mentor (Johnson & Johnson)||2004|
Transvaginal mesh litigation is ongoing, with plaintiffs accusing companies of design and manufacturing defects, failure to warn, breach of warranty, fraud, violations of state consumer protection laws, and loss of consortium. Women are also seeking compensation for injuries including severe chronic pain, infections, mesh migration and erosion, and nerve damage.
Get Help With Your
Transvaginal Mesh Claim
If you or someone you know suffered painful injuries after being implanted with a transvaginal mesh device, you may be able to pursue compensation. When you work with an experienced attorney at Parker Waichman, we’ll evaluate your case for free, and you’ll pay nothing out of pocket for our services: we only get paid from a portion of your settlement or jury verdict. Our lawyers will fight tirelessly for your legal rights as they compile evidence for your transvaginal mesh lawsuit, update you on the discovery process, advise you on any potential settlement offer, and advocate for you in court. At Parker Waichman, we’re here for you every step of the way to answer your questions, starting with your initial consultation.
When you need a top lawyer for a transvaginal mesh lawsuit, our attorneys are only a phone call away. Call 1-800-YOUR-LAWYER (1-800-968-7529) or fill out our online form today for a free consultation.