Boston Sci Updates Pelvic Mesh Warnings

Company says product can be difficult if not impossible to remove, and added scarring, scar contracture, and "ongoing pain" to the list of adverse events.

Nancy Crotti

Boston Scientific recently updated its warnings about its pelvic mesh products and directions for use.

The field safety notices cover mesh implants used to treat stress urinary incontinence, and pelvic organ prolapse. The company added the warning that mesh is a permanent implant that "has been associated with cases of erosion" in the bladder, vagina, urethra, ureter, and bowel, "regardless of the route of delivery."

Treatment may require surgical removal, but removal may involve multiple surgeries that may not be completely successful, the notice said.

The warning also said mesh implant surgery may cause perforation or laceration of blood vessels, nerves, bladder, urethra, and/or bowel. The company added possible adverse events, including scarring, scar contracture, and "ongoing pain."

Physicians should consider the risks of implanting mesh into patients with treated and untreated blood clotting disorders, hypertonic bladders, or vesico ureteral reflux, the company added.

The company added a list of risk factors to the pelvic floor from mesh surgery from impaired vascularity due to diabetes, smoking status, estrogen status, and radiation exposure; age; pelvic floor myalgia; impaired wound healing; and active infection in or near the surgical site.

The notices list the names of all the products covered.

Like other mesh manufacturers, the Marlborough, MA-based company has had its share of legal woes over the polypropylene devices. In June 2015, a Delaware jury awarded $100 million to one plaintiff who claimed that revision surgeries to remove two Boston Sci mesh implants left components of the products lodged in her body, continuing to cause her pain. That jury also found that Boston Sci had been negligent in designing the devices, wittingly hid design flaws from physicians, and did not adequately warn patients or physicians of its potential risks.

Boston Scientific's legal bills have been especially high in the past couple of years, as it wrestles with more than 25,000 lawsuits related to vaginal mesh. 

In 2014, the company was forced to pay $73 million to a Texas woman treated with the company's Obtryx mesh device.

Despite the multitude of lawsuits and major monetary awards, Boston Sci still collects $120 million in annual revenue on average from the sale of the product, which is implanted in roughly 55,000 women each year, a federal lawsuit filed in January noted.

Nancy Crotti is a contributor to Qmed.

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