Boston Scientific: Vaginal implants

2021: Fine of $188.6 million for defective vaginal implants

At the end of March 2021, Boston Scientific agreed to pay a fine of $188.6 million to 47 states and the District of Columbia to resolve claims over the sale of defective transvaginal nets.

Transvaginal implants, first developed in the early 2000s, were intended to support weakened muscles and ligaments of the pelvic floor. However, these products have been the subject of thousands of lawsuits, as many women complained of dangerous side effects, such as pronounced pain, severe bleeding and loss of sexual function.

Boston Scientific and Coloplast remained the last two companies to continue selling these devices. In the end, US regulators banned the sale of transvaginal nets in 2019, but this did not end.

Boston Scientific to pay $190 million to resolve claims over the sale of defective transvaginal nets

The complaint against Boston Scientific alleges that the company never disclosed the full range of potentially serious and irreversible complications caused by transvaginal mesh implantation. In addition to the cash payments, Boston Scientific has agreed to marketing, training, and clinical research reforms that should correct serious problems in the company's operations that have caused many proceedings.

A Boston Scientific statement issued by MassDevice noted that the company is willing to settle claims but does not acknowledge its misconduct or liability, which is in the interests of the company and its shareholders:

We are pleased to resolve this dispute and continue our work on innovative products and solutions.

The investigation into the company, as a result of which a settlement agreement was reached, was conducted by law enforcement agencies of the states of California and Washington. According to the company's latest annual reports, Boston Scientific's legal costs amounted to $330 and $278 million in 2019 and 2020, respectively, with most of the settlements related to transvaginal mesh sales.^[1]

2020: Boston Scientific to pay tens of millions for defective transvaginal implants

In early March 2020, Boston Scientific agreed to pay Canadian women $21.5 million in a lawsuit about defective transvaginal implants. Boston Scientific has promised to pay compensation to 325 women. The proportion of each plaintiff will depend on the severity of medical problems. Final judicial approval is expected in June 2020.

Health Canada pledged to consider the use of transvaginal implants for women with pelvic prolapse in July 2019, three months after regulators banned the sale of implants in the United States. A recent long-term observational study of 54,194 women who underwent transvaginal mesh implantation revealed multiple complications. These include chronic inflammation, mesh contraction and ingrowth into scar tissue, infections, bleeding, pain during intercourse, organ perforation, bulging through the vaginal wall, and urinary problems. Implant manufacturers have already paid millions of dollars in numerous lawsuits.

Boston Scientific agrees to pay Canadian women $21.5 million in defective transvaginal implant lawsuit

Boston Scientific is the only company that continues to sell transvaginal nets in Canada, according to a Canadian Press report. Susan Vester, who was implanted with the device in 2010, became the lead plaintiff in this case, which was certified as a class action in 2017. Lawyer Wester and her husband said they were happy with the court's decision. Boston Scientific did not respond to the request.

BSX CFO Daniel Brennan told investors in February 2020 that the company has already settled or is close to settling more than 95% of all claims over transvaginal implants. The company expects to pay the remaining $115 million to settlement funds in 2020.^[2]

2017: Defective Boston Scientific vaginal implants in thousands of women

In May 2017, a story was continued accusing Boston Scientific of selling defective vaginal implants. The company won one trial and tried to challenge dozens of other complaints.

For several years, Boston Scientific received a huge number of lawsuits from dissatisfied users of the company's vaginal implants, which caused various deviations, including constant pelvic pain.

Uphold vaginal implant

By May 2017, lawsuits from 84 women in 33 American states remain open. They claim that in different years (2001-2013) they were implanted with Boston Scientific transvaginal nets, which caused various health problems. Most of the complaints were filed in a Missouri court, but, according to the manufacturer, this authority does not have appropriate jurisdiction to hear the case, since Boston Scientific is registered in Delaware and conducts its main business in Massachusetts. In this regard, the company asks the US Supreme Court to cancel the claims.

There have been lost legal cases involving vaginal implants in Boston Scientific history. However, not all plaintiffs were able to prove their case. So, Martha Carlson claiming that she did an injury as a result of implantation of a grid of Uphold in 2010 lost the suit in May of the 2017th. A federal appeals court ruled that Carlson did not provide sufficient evidence to indicate that Boston Scientific "acted recklessly in developing the Uphold device and its instructions."

In total, several thousand similar lawsuits have been brought against the company. Part of the claims in West Virginia were combined. During the court proceedings, all plaintiffs argued that Boston Scientific was unable to provide data on the safety of medical devices in a hurry to release them to the market.

Boston Scientific is not the only company facing lawsuits over vaginal implants. Similar charges were brought against CR Bard and Ethicon, part of Johnson & Johnson Corporation.^[3]

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