Since 2008, women have been pursuing cases against transvaginal mesh companies for injuries they experienced after receiving the implants. After getting surgery to treat pelvic organ prolapse and stress urinary incontinence, the women began to suffer complications from the mesh, including pain, infection, and organ perforation. In 2019, the FDA ordered the manufacturers to stop selling the devices.
Over the years, women have won verdicts totaling more than $300 million. The companies that sold the transvaginal mesh have also settled thousands of claims, with total settlements amounts in the billions.
Transvaginal Mesh Implants
Transvaginal mesh, also called pelvic mesh, is a surgical implant for women with pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Surgeons implant the mesh on weakened tissue to provide support where organs have begun to sag into the vaginal canal. Most transvaginal mesh combines synthetic and biologic (animal tissue) materials and these implants are either absorbable or permanent.
Pelvic Organ Prolapse
For patients with POP, the surgeon implants mesh on the walls of the vagina to provide support for the bladder, bowel, rectum, or uterus. POP is common in women who have given birth or had a hysterectomy. Mesh implants for this condition are typically permanent.
Stress Urinary Incontinence
Women often experience SUI after childbirth or menopause. Weakened pelvic muscles lead to urine leakage when coughing, sneezing, standing, or other physical activity. Transvaginal mesh fixes this by acting as a sling that holds up the urethra.
Injuries Caused by Transvaginal Mesh
Women who received transvaginal mesh have complained of painful injuries due to the device. Many of these women can no longer live a normal life; they have trouble standing, sitting, having sex, and doing other normal day-to-day activities. For that reason, thousands of women have filed lawsuits against the companies that make transvaginal mesh.
Complications of Transvaginal Mesh
- Pelvic pain from nerve damage, cuts, or mesh shrinkage
- Erosion of vaginal walls or internal organs
- Infections from bacteria growing on implants
- Difficulty urinating because of the device blocking the bladder
- Recurring prolapse when mesh fails
- New or worsened incontinence
A 2017 medical study found that the complication rate of transvaginal mesh implants is up to 9.8% of women who receive them. Many women who suffer complications require additional surgical procedures to fix the problem. Unfortunately, the mesh can be difficult or sometimes impossible to remove because it fuses with the surrounding tissues.
Transvaginal Mesh Multidistrict Litigation
Women have filed over 100,000 lawsuits alleging that transvaginal mesh causes severe complications, and the manufacturers have paid out billions of dollars to plaintiffs. Most cases ended in settlements, but some women won millions in court verdicts against the companies that made the devices.
In 2012, the federal courts consolidated the hundreds of thousands of lawsuits against transvaginal mesh companies into multidistrict litigation (MDL) cases. The MDLs are in the Southern District of West Virginia, where the judicial panel formed an MDL in 2008 for lawsuits against a transvaginal mesh device called ObTape.
The MDLs involve a few major manufacturers, including C.R. Bard, American Medical Systems, Boston Scientific, and Ethicon. Ethicon, Johnson & Johnson’s child company, has faced the most lawsuits from injured parties, totaling over 40,000.
The mesh lawsuits are product liability cases focusing on the defendants’ negligence or strict liability regarding the defective products. In cases involving defective products, plaintiffs can claim the following:
- Manufacturing defect
- Design defect
- Failure to warn
The complexity of product liability cases means they can take a very long time, requiring a lot of discovery between the parties before a trial can take place. MDLs allow plaintiffs from many different cases to share evidence, allowing them to build more substantial claims against the defendant companies.
The mesh lawsuits accuse manufacturers of:
- Failing to warn people of potential complications
- Failing to research the risks of the mesh devices
- Intentionally misleading the FDA, the medical community, and the public about the safety and effectiveness of mesh products
- Failing to test the devices properly
- Failing to create safe methods to remove the mesh
The plaintiffs claim that the testing and approval of transvaginal mesh products were woefully inadequate. For example, Ethicon’s TVT-Secur product had only five weeks of testing before it went on the market, and the test subjects were sheep plus 31 women. A 2017 study that reviewed the FDA approval process of transvaginal mesh found that the products received approval “on the basis of weak evidence.”
Settlements and Verdicts
By February 2019, 32 women had gone to trial with transvaginal mesh lawsuits, and the juries had awarded 24 of those women a total of $345 million. Ultimately, the mesh manufacturers paid almost $8 billion in settlements across thousands of cases.
A woman named Christine Scott won the first major verdict in the transvaginal mesh lawsuits. In 2012, the jury awarded her $5.5 million in her case against manufacturer C.R. Bard. One of the highest awards for damages went to Patricia Mesigian in 2019, who won $30 million in compensation and an additional $50 million for punitive damages from her lawsuit against Ethicon. Mesigian suffered from pain, inflammation, and infections, and surgeons could only remove part of the mesh implant.
A Philadelphia woman, Susan McFarland, had Ethicon’s mesh device implanted in 2008 for stress urinary incontinence. As a result, she suffered severe pain and infections, and the symptoms continued even after having the mesh removed. McFarland won a total of $120 million in her 2019 case against Ethicon.
Hiring a Lawyer for a Transvaginal Mesh Lawsuit
Judicial panels have combined many of the lawsuits against transvaginal mesh manufacturers into MDLs, where a single judge hears the evidence for all cases. This process streamlines pretrial motions and discovery.
Once the MDL judge has ruled on an individual’s case, the lawsuit returns to the plaintiff’s original court. The trial continues with the evidence and rulings from the MDL but focuses more on the individual’s experiences, such as their specific injuries resulting from the transvaginal mesh implant.
Mass Tort Resource can help you with your mass tort litigation case. Call us today at 844-636-7459 or fill out our online form for a free consultation.