Boston Scientific updates warnings for pelvic mesh products

Boston Scientific (NYSE:BSX) recently updated the directions for use and warnings for its pelvic mesh products, classifying the meshes as permanent implants and warning of complications related to removals.

The Marlborough, Mass.-based company added new precautions to the directions for the meshes, warning that that “regardless of the route of delivery,” the meshes have been associated with “erosion” which may require surgical removal.

“Complete removal of mesh may not be possible and additional surgeries may not always fully correct the complications,” the company wrote in its updated guidelines.

Adverse event risks associated with the device were updated to include that perforation or laceration of vessels, nerves, bladder, urethera or bowel may occur during placement. Scarring, scar contracture and ongoing pain were also added to the list of possible adverse events.

The company also warned that “In some instances the response to these events may persist as a permanent condition after the intervention,” according to the press release.

Risk factors which “impact patient outcomes” with the devices were also updated to included impaired vascularity, such as diabetes or smoking, age, pelvic floor myalgia, impaired wound healing or active infections at the surgical site.

Boston Scientific said these factors, as well as issues with untreated coagulopathies and patients with hypertonic bladders or vesico ureteral reflux should be taken into consideration before performing procedures with the devices.

Last October, Boston Scientific saw its $100 million payment over a lost pelvic mesh lawsuit slashed to $10 million by a Delaware judge.

Judge Mary Johnston in New Castle County, Delaware, said that the damages awarded to plaintiff Deborah Barba last May – the largest ever in a trial involving transvaginal mesh – were “grossly disproportionate to the injuries suffered and shock the court’s conscience and sense of justice.”

But Johnston denied Boston Scientific’s bid to set aside the verdict altogether and order a new trial. While the jury had properly decided the company’s liability, Johnston wrote in her ruling that the jury’s award was too high, particularly in comparison with the other mesh trials, in which punitive damages awards spanned from $1.75 million to $7.76 million.

The post Boston Scientific updates warnings for pelvic mesh products appeared first on MassDevice.

from MassDevice http://ift.tt/1Q0Kdy0