TVT mesh shrinkage leads to nerve entrapment and thus, chronic pelvic pain, erosions, urinary/defecatory/sexual

dysfunction, recurrence and the need for reoperation to remove some or all of the contracted mesh and excessive scar tissue, thereby making TVT unsuitable for its intended use as a

permanent pelvic implant to treat stress urinary incontinence in women. 

    As such, Ethicon failed to act as a reasonable manufacturer of surgical mesh intended to treat stress urinary incontinence

in women by failing to design a sling device that would resist such a high level of shrinkage. 

    Defense case specific and general experts have routinely claimed that the mesh does not shrink but, rather, the tissue surrounding the mesh shrinks when normal scar tissue forms around the mesh.

    According to Linda Dunfee’s doctor, Dr. Della Badia, an obgyn for 30 years, there was no shrinking, roping or curling, he claims only Dr. Bercik found this.

    According to Dr. Salil Khandwala, the defense general case expert, vaginal tissue has to retract, as a natural part of the healing process the tissue contracts and shrinks. He does not think the mesh shrinks, he testified that the tissue surrounding the mesh shrinks.

    Dr. Khandwala was shown Ethicon power point slides which state "factors related to mesh shrinkage."

    Plaintiff expert witnesses testify that the mesh does shrink. Mr. Scott Ciarrocca, the scientific project lead for the Prolift, testified that the mesh does shrink and was shown several Ethicon slides that described mesh shrinkage.

    Pre-launch studies showed back in 2006 that there was a 17% shrinkage rate. This was stated during Plaintiff’s rebuttal closing statement in the Linda Dunfee trial.

    Dr. Bercik testified that the small pores lead to fibrotic bridging, increased shrinkage and mesh contraction.