Transvaginal Mesh Lawsuit

Transvaginal mesh implants were approved by the Food and Drug Administration (FDA) in 2002 and have been widely used since then. The implants were designed to help sufferers of pelvic organ prolapse or stress urinary incontinence (SUI). Several years after the implants were approved, complaints of health issues began to surface, and lawsuits quickly followed. Thousands of lawsuits are believed to have been filed against the manufacturers, and more are expected to come.

Experienced law firms are helping victims who have suffered severe injuries from transvaginal mesh implants file lawsuits for financial compensation. The Guardian Legal Network helps victims of transvaginal mesh find skilled legal counsel. To connect with an experienced transvaginal mesh lawyer, contact us today.

Complications from Transvaginal Mesh

Mesh products have been used to repair hernias since the 1950s, but this product has been reported to shift positions within a patient’s body and/or cause infection. A different type of mesh is used today in transvaginal mesh devices. However, similar problems with infection and device shifting are still occurring in patients who receive newer transvaginal mesh implants. The extent of the injuries and complications reported with transvaginal mesh implants seems to be even greater than those experienced by hernia mesh patients.

Transvaginal mesh complications can be severe. The following are side effects and injuries reported in some women who have a transvaginal mesh implant:

Organ Perforation – The mesh may shift positions. If so, the mesh may come into contact with an organ and perforate the organ.
Transvaginal Mesh Erosion – Over time, the mesh degrades. When this happens, it may fail, or the eroded mesh substance may harm other parts of the body.
Infection – Manufacturers claim the mesh material is inert and chemically inactive. However, there are some cases where a reaction occurs at the mesh site within the body.
Bleeding – The vaginal mesh may irritate and rub against organs, causing bleeding.
Painful Intercourse – The vaginal mesh may be felt inside the body.

Complications from transvaginal mesh implants can be debilitating and result in long-lasting harm. Estimates of the rate of complications after having a vaginal mesh implant range from 10 to 40 percent. Below are some statistics:

From 2005 to 2010, there were 1,766 medical device reports related to complications of vaginal mesh devices.
Of the 75,000 vaginal mesh surgeries done in 2010, 10 percent of patients reported complications.

When media reports announced the death of a transvaginal mesh patient, the public began to pay attention. The woman died from sepsis that resulted from infection due to her transvaginal mesh implant. By 2016, the classification of transvaginal mesh was changed by the FDA to high-risk.

FDA Halts Sale of Transvaginal Mesh

On April 16, 2019, the FDA demanded that manufacturers (Boston Scientific and Coloplast) of surgical mesh used for transvaginal repair of anterior compartment prolapse (cystocele) halt the sale and distribution of the product immediately. The FDA’s order said the remaining companies selling the medical device failed to show that the mesh is safe for long-term use. Women are advised to speak with their health care provider if they experience complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex. The FDA also recommends that women who were planning to get transvaginal mesh to repair pelvic organ prolapse should discuss other treatment options with their doctor.

Filing a Transvaginal Mesh Lawsuit

Women who have been injured by complications from a transvaginal mesh implant can bring legal action against the manufacturer by filing a lawsuit. Plaintiffs may qualify to receive:

Reimbursement for past and future medical costs
Compensation for pain and suffering
Lost wages from missing work if mesh complications are the cause
Loss of consortium (spouse’s companionship, relations, services)
Punitive damages from the manufacturer if misconduct is determined

Transvaginal mesh lawsuits fall into the category of product liability. This means that your case must show that the product is defective and that your injury is due to the defective product. Lawsuits surrounding transvaginal mesh devices have made claims such as these:

The mesh was designed defectively, allowing it to shift and/or degrade.
The device was defective, and the manufacturer is liable for harm suffered in all circumstances.
The mesh was defectively manufactured, thereby causing complications and harming women.
The manufacturer knew or should have known the side effects but did not warn women before the devices were implanted.
The defendants negligently designed and made a faulty product.
Transvaginal mesh devices violated warranties by failing to work for the intended purpose of treating stress urinary incontinence (SUI) and pelvic organ prolapse.

When filing a transvaginal mesh lawsuit, you need to be aware of the statute of limitations, which is a law that sets a time limit on when a victim can file a claim. The specific time limitations depend on the state. Most states require that a product liability lawsuit be filed within two years from the date of injury. Fortunately for victims, the two-year time limit does not begin when the faulty mesh is implanted. It starts when the recipient of the medical device knows or should know that she is injured. Therefore, a woman who received the mesh many years ago may still be able to file a lawsuit. Since this medical device is a “ticking time bomb” in many women’s bodies, injuries will likely continue to surface. The number of lawsuits being filed will continue to rise in the future.

Transvaginal Mesh Settlements

Several mesh manufacturers chose to settle claims filed against them. Endo International plc purchased the manufacturer of the original mesh. Endo settled claims against the mesh product for $775 million. In addition, the company stopped making and distributing the device. Several smaller manufacturers followed suit and also settled their cases.

Some larger manufacturers have chosen to fight lawsuits brought against them. Johnson & Johnson, who distributes its transvaginal mesh devices through Ethicon, was dealt major blows when juries entered several large verdicts against the company. One verdict was $35 million. Johnson & Johnson did settle thousands of other suits brought against its mesh product. Boston Scientific, another maker of transvaginal mesh products, had a $100 million verdict, which was later reduced to $10 million.

On October 17, 2019, J&J agreed to pay a $117 million settlement to resolve claims that the company deceptively marketed the product as safe and failed to warn patients and doctors about the dangerous side effects of the vaginal mesh implant. In just a few months later, J&J was ordered by a California judge to pay $344 million in damages because the company deceptively marketed transvaginal pelvic mesh implants to tens of thousands of women in California.

In September 2020, Becton Dickinson and Co agreed to pay $60 million to resolve allegations by the attorneys general of 48 U.S. states and Washington D.C. that its CR Bard unit concealed the risks of its now-discontinued transvaginal pelvic mesh devices.

Find a Transvaginal Mesh Lawyer Today

Large medical device companies will not admit liability easily. When a company faces tens of thousands of these lawsuits, they do not want to pay out the full amount of each claim. If the company offers a settlement, the amount will likely favor the company itself, not the injured party. This is where a strong legal representative is necessary to ensure that a plaintiff’s financial interest is protected. Attorneys with experience handling defective medical device lawsuits will analyze scientific evidence and use expert witnesses to build a case.

Contact The Guardian Legal Network to find a qualified transvaginal mesh lawyer who will help you hold a negligent manufacturer responsible for your damages.

References

FDA. “Urogynecologic Surgical Mesh Implants: Reporting Problems to the FDA”, U.S. Department of Health and Human Services, https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/urogynecologic-surgical-mesh-implants-reporting-problems-fda. Accessed January 18, 2021.
Mayo Clinic. “Get the facts about transvaginal mesh complications”, Mayo Foundation for Medical Education and Research, https://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/in-depth/transvaginal-mesh-complications/art-20110300. Accessed January 18, 2021.
Hemendra N. Shah, Gopal H. Badlani. “Mesh complications in female pelvic floor reconstructive surgery and their management: A systematic review”, US National Library of Medicine National Institutes of Health, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3424888/. Accessed January 18, 2021.
Matthew Goldstein. “As Pelvic Mesh Settlements Near $8 Billion, Women Question Lawyers’ Fees”, The New York Times, https://www.nytimes.com/2019/02/01/business/pelvic-mesh-settlements-lawyers.html. Accessed January 18, 2021.
Department of Surgery, Division of Urology. “The Truth Behind Transvaginal Mesh Litigation: Devices, Timelines, and Provider Characteristics”, Female Pelvic Medicine & Reconstructive Surgery, https://journals.lww.com/jpelvicsurgery/Abstract/2018/01000/The_Truth_Behind_Transvaginal_Mesh_Litigation__.4.aspx. Accessed January 18, 2021.
Toyohiko Watanabe, MD, PhD and Michael B Chancellor, MD. “Pelvic Surgeons Caught in the Meshes of the Law”, US National Library of Medicine National Institutes of Health, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3502050/. Accessed January 18, 2021.