Pinnacle pelvic floor kit  brochure recalled by the fdaThe two week trial of Diane Albright v. Boston Scientific d/b/a Mansfield Scientific, Inc. and Microvasive, Inc. is expected to go to the jury Monday, July 28, 2014 after closing arguments.

The product liability lawsuit was filed in Middlesex Co in Massachusetts, Superior Court Action 12-0909.

Boston Scientific is headquartered in Middlesex County, MA.

On March 9, 2010, Albright received the implant made by Boston Scientific – the Pinnacle Pelvic Floor Repair Kit.  The mesh was implanted at Mary Rutan Hospital in Bellefontaine, Ohio.

Albright did not, according to her complaint, receive any informed consent about what could go wrong or mesh injuries which was “negligently designed and manufactured,” according to her complaint.

Neither Albright or her doctor were warned about the dangers of pelvic mesh or that there were safer alternatives to address her pelvic organ prolapse. She was diagnosed with a recurrent cystocele.

Boston Scientific should have known about the complications associated with its product, according to the  Albright Stamped Complaint.

Those complications include the design and manufacture of the mesh, the raw plastic edges made of polypropylene, a polymer plastic that incites immune and foreign body reaction. The transvaginal placement introduces bacteria into the body; the biomechanical issues that result from the bio incompatibility of plastic mesh and delicate tissue; the pelvic mesh anchors placed too near major nerve routes; and the degradation of mesh over time.

The product liability action says the mesh is defective in its design and manufacture and that the company was negligent in its failure to disclose to Albright and her physician the defective nature of the medical device that had the potential to cause mesh erosion, failure and permanent injury.

In fact, according to the complaint, the company over-promoted the safety and efficacy and benefits of the Pinnacle even though it had not conducted clinical trials to assure patient safety since they were not mandated by the Food and Drug Administration (FDA).

According to the FDA here: logo

“In 2011, Boston Scientific issued a class 2 recall for the Pinnacle Pelvic Floor Repair Kit because ‘the device may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement.”

The three counts charged are breach of warranty, negligence and a failure to warn. The Albright case was filed in Massachusetts March 6, 2012.

She is represented by Fidelma l. Fitzpatrick and Jonathan D. Orent of Motley Rice.

Mesh News Desk does not have a reporter in the courtroom in Woburn, Mass. so has to rely on documents coming out of the court. Anyone interested in attending is invited to share her courtroom observations with Mesh News Desk.  Thank you!