A company that failed to adequately inform women of dangerous side effects related to permanent pelvic mesh devices will be required to pay $60 million, according to a settlement announced this week by state attorneys general across the U.S.
The money from C.R. Bard Inc. and its parent company Becton, Dickinson and Company will be spread out among 48 states and the District of Columbia. For example, New York will receive $2.1 million, while Arizona will receive $1.15 million. Mississippi is set to receive around $840,000.
Evidence indicated that C. R. Bard was aware of the potential for serious medical complications but failed to provide sufficient warnings to consumers or surgeons who implanted the devices, said New York Attorney General Letitia James in a statement.
"C.R. Bard failed to disclose serious and life-altering risks of permanently implanted surgical mesh devices, leaving thousands of women to suffer," Mississippi Attorney General Lynn Fitch said in a statement. "This settlement holds Bard accountable for its deceptive business practices."
Troy Kirkpatrick, a spokesperson for Becton, Dickinson and Co., said Friday morning that C.R. Bard and its parent company have denied any allegations of wrongdoing. He said the company chose to settle the matter "to avoid the time and expense of further litigation."
The litigation involving C.R. Bard's pelvic mesh product began prior to its acquisition by Becton Dickinson in 2017. Kirkpatrick said that "ensuring the safety and quality of products has always been the top priority at BD" and that the company is in full compliance with laws and regulations.
Latest company to pay large sum
C.R. Bard is just the latest manufacturer of transvaginal mesh, a net-like implant used to treat stress urinary incontinence (SUI) and pelvic organ prolapse, to be required by the court to pay a large sum.
In 2019, after patients reported serious complications — including erosion of mesh through organs, pain during sexual intercourse, and voiding dysfunction — the U.S. Food and Drug Administration banned sales of all mesh products used for pelvic organ prolapse repair.
"In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP," Jeffrey Shuren, a physician and director of the FDA's Center for Devices and Radiological Health, said in a statement posted on the FDA's website at the time the ban was made.
In October of last year, Johnson & Johnson agreed to pay a $117 million settlement with 41 states and the District of Columbia over similar allegations involving mesh devices. In January, a judge ordered Johnson & Johnson to pay nearly $344 million in additional penalties for deceptive marketing of the product.
SUI and pelvic organ prolapse are common conditions faced by women due to a weakening in their pelvic floor muscles caused by childbirth, age and other factors. About one in eight women has surgery to repair their pelvic organ prolapse during their lifetime, with a portion of those surgeries completed transvaginally using surgical mesh, according to the FDA.
The percentage of transvaginal POP mesh procedures has declined in recent years amid warnings about the associated risks.
Millions of women implanted
Millions of women were implanted with transvaginal mesh before it was pulled from the market, Attorney General Fitch said. The controversial devices, which are made of synthetic or biological material, have sparked tens of thousands of lawsuits by women claiming the mesh had caused life-altering pain and injury.
C.R. Bard has stopped selling the devices, New York attorney general James said. Along with paying the $60 million, C.R. Bard will be required to adhere to new requirements for marketing if the company chooses to sell the product again, including the need to disclose all potential complications associated with the product in marketing materials.