Although patients were assured that having transvaginal mesh inserted is a low-risk procedure, its complications can be life-changing. Thousands of women experienced complications such as: device erosion, infection, organ perforation, intense pain and inability to have intercourse. Many of these women have had to undergo multiple revision surgeries to attempt to manage symptoms and have since filed transvaginal mesh lawsuits against the device manufacturers. The plaintiffs’ lawyers claim the products are defective, insufficiently tested and that manufacturers failed to warn women of the potential risks.
Transvaginal mesh is used to treat pelvic organ prolapse (POP) – a condition where organs fall through the pelvic floor and into the vagina – and stress urinary incontinence (SUI). When used to treat incontinence, the mesh is also referred to as a bladder sling.
However, the products are controversial because they were approved by the Food and Drug Administration (FDA) based on their similarity to older products, some of which have been recalled. Furthermore, the FDA now says that “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP.” Further, the treatment “may expose patients to greater risk.”
Johnson & Johnson and C.R. Bard have since pulled a number of their mesh products off the market, but the decisions came too late for thousands of women now living with painful complications. Johnson & Johnson and other mesh manufacturers face more than 12,000 federal lawsuits, with approximately 4,000 more pending in state courts.
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Status of Transvaginal Mesh Lawsuits
Because these transvaginal lawsuits were filed across the United States and offer many of the same allegations related to pelvic surgical mesh products, a judicial panel transferred several thousand cases filed in various federal courts to the U.S. District Court for the Southern District of West Virginia under Chief Judge Joseph R. Goodwin.
The cases have been placed into groups, known as multidistrict litigation (MDL), which involve similar claims against common defendants. Because of the similarities, these cases are often called mass torts. Transferring them to a single court helps the federal court system process them more efficiently.
Judge Goodwin, has been assigned to manage more than 12,000 cases involving the following companies:
|MDL Name||Number of Cases|
|MDL – 2187, IN RE: C.R. Bard, Inc., Pelvic RepairSystem Products Liability Litigation||1,956|
|MDL – 2325, IN RE: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation||3,974|
|MDL – 2326 IN RE: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation||2,317|
|MDL – 2327 IN RE: Ethicon, Inc., Pelvic Repair System Products Liability Litigation||3,798|
|MDL – 2387 IN RE: Coloplast Corp. Pelvic Support Systems Products Liability Litigation||188|
The first case scheduled for trial in this group of MDLs is one of the cases from MDL No. 2187. Trial preparation began in February 2013. The next scheduled trial will begin in December 2013 against American Medical Systems, Inc. (MDL No. 2325). Next, come trials against J&J’s Ethicon, followed by those against Boston Scientific.
In a recent meeting with attorneys for the plaintiffs and defendants, Judge Goodwin encouraged all attorneys to come up with ways to make the litigation process go more smoothly. He also said he would limit the number of days for each trial to expedite the process.
Another MDL, against Mentor Corp. for its ObTape vaginal sling, is taking place in the U.S. District Court for the Middle District of Georgia. MDL No. 2004, presided over by Judge Clay D. Land, is slowly moving forward. Johnson & Johnson bought Mentor Corp. in 2009 and settled with some plaintiffs after the first trial got under way, but more than 100 suits remain.
Transvaginal Mesh Trials and Jury Verdicts
Two women have received sizable verdicts after suing mesh manufacturers for their injuries. In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries. Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product.
In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product. Gross had 18 surgeries. The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.
How We Can Help
Drugwatch is dedicated to helping people affected by dangerous drugs and medical devices like transvaginal mesh. We offer online resources to help women understand the complications they may be going through because of mesh, as well as a Q&A with a urogynecologist who is also a mesh removal specialist.
In addition to the online resources, our Patient Advocates talk to women one-on-one about their individual situations and experiences with transvaginal mesh. They are available seven days a week to help you or a loved one understand mesh complications, recalls and options for treatment such as revision surgery for mesh removal.
If you are thinking about suing a mesh manufacturer, our advocates can help you make sense of the complex legal process. They can also help you locate an experienced product liability lawyer.
Why Women File Lawsuits for Transvaginal Mesh Injuries
Mesh can begin to erode through the vaginal walls or other organs within weeks or months after surgery. It may tighten or shift, causing it to protrude into the vaginal canal.
These transvaginal mesh injuries can hinder any number of activities, including sitting, walking and sexual intercourse. The physical and emotional harm can affect women’s work, relationships and daily activities.
For many women, there is no way to undo this harm. Multiple surgeries may be required to remove pieces of mesh. However, the mesh cannot always be removed completely. Even after a number of corrective surgeries, complications may continue.
A number of these women file lawsuits to recover financial and emotional damages as well as loss of quality of life. Husbands also sue, claiming loss of consortium because mesh interferes with their ability to be intimate.
Some experts argue that the surgical mesh is not safe for transvaginal placement and was not properly tested before being implanted into women. According to the lawsuits already filed, device makers had a duty to thoroughly test surgical mesh for transvaginal placement before marketing it for that use.
If transvaginal mesh companies are found liable for breaching their legal duties to patients, plaintiffs may be eligible for compensation for injuries and losses, including:
- Medical expenses, including the costs of additional surgeries
- Loss of wages
- Loss of spousal consortium
- Losses to quality of life
- Pain and suffering
Transvaginal Mesh Class-Action Lawsuits
Participating in a transvaginal mesh class-action lawsuit may be another option for women who have been injured by pelvic surgical mesh. Class-action lawsuits give large groups of claimants the opportunity to litigate their claims together. However, forming a class action is a special legal process, and once claimants decide to participate in the class, they waive their right to file a separate lawsuit. For better or worse, they agree to whatever result the entire class receives.
Women Who Filed Transvaginal Mesh Lawsuits
Women who filed transvaginal mesh manufacturers allege that mesh manufacturers “had a legal duty to insure the safety and effectiveness of their pelvic mesh products,” but instead provided patients with “false and misleading information” about the products’ effectiveness and safety.
Judy Conlin of Corbin, Ky., had mesh products from Boston Scientific and Ethicon implanted to treat prolapse and incontinence in July 2011.
Judy and her husband, Timothy, filed a lawsuit against both mesh manufacturers after she claims their mesh products caused severe injuries, including:
- Extreme pain
- Mesh erosion
- Dyspareunia (painful sexual intercourse)
- Abdominal and pelvic pain
- Recurrence of urinary incontinence
- The need for multiple surgeries
The Conlins’ lawsuit claims the defendants failed to warn, are guilty of fraud and concealed that their products could cause permanent and debilitating injuries.
Other lawsuits accuse mesh manufacturers of several counts, including:
- “Actively and intentionally misleading the FDA, the medical community, patients and the public at large” with respect to the safety and effectiveness of transvaginal mesh products.
- Failing to conduct proper testing and research to determine the risks of surgical mesh for use to treat female pelvic floor disorders.
- Failing to establish safe and effective methods for removal of transvaginal mesh.
- Providing insufficient and misleading training and information to doctors to increase the sales of their transvaginal mesh products.
- Continuing to sell transvaginal mesh while being aware of the harmful complications it may cause.
- Failing to adequately warn of potential complications and injury.
- Producing a defective product that is “unreasonably dangerous and hazardous to certain plaintiffs.”
- “Placing their economic interests above the health and safety of plaintiffs and others.”
If you or a loved one suffered from erosion, organ perforation, nerve damage, severe pain or any other complications from a transvaginal mesh product, Drugwatch can help. Call and speak to one of our Patient Advocates. We can help you decide if filing a transvaginal mesh lawsuit is an option for you.