The closure of Astora Women’s Health, a medical device maker in Eden Prairie, is expected to affect about 130 employees in the state.
Astora’s parent company, Ireland-based Endo International PLC, revealed in a quarterly-earnings announcement this week that Astora Women’s Health will wind down operations by March 31 because of unrelenting product litigation over its pelvic mesh devices. Astora sells devices pioneered by the now-defunct Minnesota device maker American Medical Systems, Inc.
News of Endo’s decision to wind down Astora’s operations took some people by surprise.
The Feb. 29 closure announcement came just four days after a Food and Drug Administration advisory panel recommended commercial approval of a new surgical mesh device called the Topas that Astora was going to start selling for treatment of fecal incontinence in women.
Endo said it is closing Astora to reduce its potential product liability related to tens of thousands of device-injury lawsuits alleging severe pain and other problems from pelvic surgical meshes to treat pelvic organ prolapse and vaginal slings for stress urinary incontinence.
At least 135,000 such lawsuits have been filed worldwide against seven pelvic mesh manufacturers, including more than 46,000 cases against Endo. As of last fall, Endo had a net $1.4 billion in a mesh product liability fund and was actively negotiating settlements.
Despite the ongoing stream of TV advertising from plaintiffs’ lawyers regarding pelvic mesh devices, Astora still stands behind the safety and effectiveness of the products for women experiencing prolapse or urinary incontinence.
“At Endo, patient health is our number one priority. As such, we have decided to expedite this closure, so that the patients and physicians who may be considering an Astora device for an upcoming surgery will have the opportunity to assess alternative treatment options as soon as possible,” Endo spokeswoman Heather Zoumas Lubeski said in an e-mail.
She didn’t say how many employees would be affected by the closure, and current employees said they weren’t authorized to talk to media. An employee who recently left the company said Astora has about 200 employees in the U.S., including roughly 130 at the Eden Prairie headquarters, who would be affected by the closure. It’s not known if employees are being offered jobs elsewhere in the company.
In 2011, Endo — then known as Endo Pharmaceuticals, based in Pennsylvania — paid $2.9 billion in cash to acquire American Medical Systems (AMS), which was a market leader in pelvic health devices. The deal was supposed to create a company with a diversified slate of medical devices and branded and generic drugs to treat pain and urology.
By 2015, the Dublin, Ireland-based Endo International PLC had decided to split AMS into men’s health and women’s health divisions and find buyers for each.
Boston Scientific, which already sells female pelvic health mesh devices, acquired the men’s health division for $1.6 billion last August.
Although Endo said it received formal bids for the women’s health business, renamed Astora Women’s Health, ultimately the company decided to close the company rather than sell it.
“After a comprehensive review of the strategic business options — and particularly given the continuing legal disruptions associated with the vaginal mesh business — we have now determined that the best strategy is to wind down this business,” Zoumas Lubeski wrote.