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Albright v. Boston Scientific Pelvic Mesh Trial Wraps Monday

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!

15 Comments

  1. Kitty says:

    I am hoping some of us who live in the area will make it to court.

    • Jane Akre says:

      Kitty- that would be awesome. I would so appreciate a set of eyes in the courtroom! Please let me know if that is possible… Much appreciated! ~ ja

  2. kristine says:

    I pray she wins her case. This will just bring more justice to us women who are suffering. Living in pain and suffering mentally from not being able to cope is not fair to any of us , we can’t even work or enjoy the life we knew and loved so much. I only know the walls of my room and my bed now.

  3. aha ! I am glad to see the references finally to FBR and IMMUNE reactions ….. the autoimmune damage is a huge problem for women with autoimmune problems secondary to mesh complications … we are getting closer to the whole truth as trials expose more … when they recognize the autoimmune damage as well as pain and organ injury it will be like coming out of the dark and into the light…..

  4. stopmeshimplants says:

    Nonie, You are so right! Bring on these trials. Every single one of these trial will share more of the damage and destruction this mesh has done to our bodies. Once we settle no one will hear the entire story. I cannot wait for the entire world to know what these big Pharma companies have done for so long and how they continue to ruin our lives by implanting this mesh. I also am getting more hopeful that everyone will learn how the FDA not only allowed it to continue but did nothing to stop it. Wake up people. If you think you are safe you may not be. I did not begin having symptoms until 6 years after I was implanted and then all hell broke loose. These thousands of lawsuits are just the tip of the iceberg. Ongoing FBR, nerve damage, inflammation issues, mobility issues and that is after three surgeries to have this mesh removed. It is ugly, painful, and there is not a day that goes by that I don’t wish I had never listened to my urologist talk me into his miracle mesh kit cure for my inconvenient leak issue.

  5. jennifer says:

    Anyone hear the verdict from today?

    • Jane Akre says:

      I heard nothing but called this pm and the case had gone to the jury. One lawyer told me today BS called just two expert witnesses AND the judge allowed to survive to motions to have the case dismissed by the Defense. Perhaps as early as Tuesday! ~ ja

  6. Kitty says:

    I was also blocked by pop up. Also–Jane–I guess I worded it wrong re Court. I am not from out East and will not be visiting family there any time soon, I will be heading for FLA Aug 16 for about 1 week. I am hoping that someone will make it to court from the East Kitty

  7. sandy says:

    Tanya where did you read the verdict

  8. sandy says:

    nevermind I found it

  9. yolanda says:

    I can’t walk anymore due to nerve damage but my doctor claims he removed my bladder sling. Could. I still be suffering complications? Have anyone heard of this?

    • Jane Akre says:

      Yolanda- Did he show you the bladder sling? Did he use ultrasound to see it? Has he removed any others in their entirety? So many questions. Most removals are only partial by even qualified doctors, even when they say they “got it all.” This is one of the reasons you do not want to go to someone who is not an expert at mesh removals.

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