Marlborough medical device giant Boston Scientific Corp. is close to settling nearly 50,000 lawsuits related to a controversial mesh implant product that thousands of women allege led to infections, urinary problems, pain and other problems.
Boston Scientific (NYSE: BSX) is one of a handful of companies that make transvaginal mesh implants. The devices are used to treat medical issues such as pelvic organ prolapse, the term for when the muscles supporting organs like the bladder and uterus weaken, which Harvard Medical School reports can cause to pain and urinary problems.
Over the last decade, some 53,000 lawsuits have been filed against Boston Scientific by women who allege they received the implants and experienced painful side effects or injury.
Though the company has committed to fighting some of the remaining lawsuits, Boston Scientific has settled approximately 35,500 transvaginal mesh implant cases and is close to settling another 17,500 as of Feb. 5, the company reported in its year-end earnings report Wednesday.
The company spent $800 million to settle the lawsuits last year, according to a Boston Scientific spokesperson.
The company previously spent $119 million to settle close to 3,000 lawsuits in 2015 and has $655 million in a settlement fund, Chief Financial Officer Daniel Brennan reported during an earnings call.
Boston Scientific expects to resolve all of the mesh product cases by the end of 2019, CEO Mike Mahoney told investors earlier this month. The device maker, which has 32,000 employees worldwide, continues to manufacture and sell the implants.
A 2011 FDA probe of mesh devices made by multiple companies concluded that serious adverse events were not rare as originally thought, and that the mesh devices didn’t conclusively improve clinical outcomes. The federal agency is still investigating the devices, recently convening an advisory panel to discuss the safety of transvaginal mesh implants manufactured by Boston Scientific and other companies.
The company is still fighting some of the lawsuits, including two that allege Boston Scientific used a counterfeit resin smuggled in from China in the implants, which caused bleeding, pain and urinary problems.
"We deny the plaintiff's allegations and intend to defend ourselves vigorously," the company said of the two lawsuits.
Company's total 2017 revenue
| Rank | Prior Rank | Firm/Prior rank (*unranked in 2017)/ |
|---|---|---|
1 | 1 | Thermo Fisher Scientific Inc. |
2 | 2 | DePuy Synthes Cos, part of Johnson & Johnson Family of Companies |
3 | 3 | Boston Scientific Corp. |
