A multistate settlement of $60 million was reached on Sept. 24, 2020, with medical device manufacturer, C.R. Bard and its parent company, Becton, Dickinson and Company, following allegations that the company deceptively marketed its surgical mesh devices and failed to disclose associated risks to women and doctors.

The Bard pelvic mesh settlement will be distributed among transvaginal mesh lawsuits in 48 states and the District of Columbia, pending court approval. 

According to the complaint filed by California’s Attorney General Xavier Becerra on Sept. 23, 2020, thousands of women were injured by Bard’s surgical mesh devices. The complaint also asserts that Bard failed to disclose that surgical mesh-related complications “may persist as a permanent condition after surgical intervention or other treatment.” 

In a press release, Becerra said, “Women should be able to trust that the health products they use are safe.” He further stated, “Misleading patients and neglecting to disclose risks or side effects of medical products is dangerous, irresponsible, even deadly. Bard was caught engaging in these shameful practices, and for that, they now pay.”

In addition to the monetary settlement, Bard is also required to implement specific reforms across its corporate structure, according to the terms of the Bard pelvic mesh settlement agreement. 

What are the Terms of the Bard Pelvic Mesh Settlement?

The Bard pelvic mesh settlement set forth terms for injunctive relief, marketing reforms, and clinical trial reforms. Although Bard discontinued selling and marketing its transvaginal mesh devices as of Dec. 31, 2016, the settlement terms apply if either Bard or its parent company decides to reenter the market.

As part of the marketing reforms outlined in the settlement agreement, the medical device company may not misrepresent the safety of its pelvic mesh devices by omitting information about complications. The company must also provide descriptions of complications in terms patients can understand, and include a list of certain complications in marketing materials that address the topic. The settlement terms also require Bard ensure that those who sell or market the products to health care providers report any patient complaints or adverse effects to Bard.

Additionally, per the settlement, Bard must disclose its role as a sponsor for any clinical studies or data submitted for publication. The company also may not cite any clinical studies concerning surgical mesh if it failed to comply with the injunctive disclosure requirements, and any studies it sponsors must be registered with ClinicalTrials.gov. 

What is Surgical Mesh?

Surgical mesh devices have been used as a way to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Made from synthetic materials or derived from animal tissue, the mesh is implanted to provide additional support for weakened or damaged tissue.

Mesh may be either absorbable and degrade over time, or non-absorbable and remain permanently in the body.     

According to the FDA, one in eight women has had surgery to repair pelvic organ prolapse during their lifetimes.

What are the Risks Associated with Pelvic Mesh?

In 2019, the FDA banned all surgical mesh products used to treat pelvic organ prolapse, following safety concerns and warnings of associated risks.

Numerous risks and complications have been associated with surgical mesh devices, like pelvic mesh erosion. They may include pain, infection, torn organs, bleeding, urinary problems, recurring pelvic organ prolapse, and various other physical and emotional problems. 

Depending on the mesh-related complications, treatment may require additional surgery, pelvic floor physical therapy, or medication.

According to an article published in MedPage Today, surgical mesh-related health risks in women will continue, despite the products having been removed from the market. The article states, “Additional surgeries were performed 40% more often after 5 years in women with mesh implants than in women who had POP repair without mesh implants.” It indicates that 20% of the surgeries were related to complications. 

Are There Other Pelvic Mesh Lawsuits?

The Bard pelvic mesh settlement is just one lawsuit among thousands that have been filed across the country in recent years in connection with alleged injuries caused by surgical mesh devices.

In January 2020, California reached a settlement with Johnson & Johnson over similar allegations of deceptive marketing and concealment of the risks. According to a press release issued by the California Attorney General, more than 35,000 lawsuits were filed against Johnson & Johnson alone for claims involving its pelvic mesh products. 

In addition, Boston Scientific also recently faced several thousand claims made by women asserting they suffered health problems related to the company’s pelvic mesh devices.

Can I File a Pelvic Mesh Lawsuit?

Pelvic mesh complications can cause a number of symptoms and serious health issues. If you suffered injuries resulting from a transvaginal mesh device, you may be entitled to compensation for your economic and non-economic damages. It is best to speak with an experienced attorney who can advise you of your rights and whether you might be able to file a lawsuit or join a class action lawsuit.