HACKENSACK, N.J. (Legal Newsline) – Jury trial resumed on March 26 in a woman’s lawsuit seeking damages against a medical manufacturer whose pelvic implant device used for bladder support allegedly instead led to chronic inflammation and pain and had to be surgically removed.
Plaintiff Mary McGinnis, 62, of North Carolina, sued C.R. Bard, a New Jersey marketer of the implant device Avaulta that was used in her 2009 surgery allegedly without proper background studies or warnings of the risks of the device. The device reportedly caused intense pain in the vagina and rectum.
McGinnis eventually had to journey to California at her own expense, according to her attorney Adam Slater, to undergo vaginal reconstruction. Slater is with the firm Mazie, Slater, Katz & Freeman in Roseland, New Jersey.
The device is a clear plastic-looking polypropylene mesh with long connecting arms. The plaintiff's attorney contended the device was too large, causing McGinnis’ body to form scar tissue in efforts to reject it and that it also constricted, causing intense pain.
Streaming video coverage of the trial was provided to Legal Newsline by Courtroom View Network.
Monday’s testimony in New Jersey Superior Court in Bergen County centered on the plaintiff’s contention that traditional, less-risky surgical procedures should have been used to treat McGinnis instead of the implant device.
Dr. Anne Weber, an expert in urogynecology and a researcher and teacher on the subject of female pelvic disorders, appeared as a witness for the plaintiff.
Slater cited a study, “Risk Factors for Reoperation of Surgically Treated Pelvic Organ Relapse,” he said supported the idea conventional surgery would have been a more-effective way to treat McGinnis’ bladder prolapse.
“Why is this important?” Slater asked Weber.
“The big push behind the marketing of mesh was that there was this perceived high rate of re-operation for prolapse with traditional native tissue repairs, and that’s not the case,” Weber answered.
Weber said it was unproven whether the use of mesh in this case provided enough benefit to outweigh the risks associated with it.
The “Risk Factors for Reoperation of Surgically Treated Pelvic Organ Relapse” study, over a 20-year period, compared groups of women who had to have re-operations for their conditions as opposed to those who did not.
According to the report, approximately 94.4 percent did not need an additional operation with more traditional (suture) methods.
Because of the risk involved with mesh, Weber said it should only be used to manage prolapse in the most severe cases, considered stage three or stage four conditions. McGinnis’ level was estimated at stage two.
Slater asked Weber if, in her opinion, McGinnis would have met the criteria to use mesh?
“No,” Weber answered.
Under cross-examination, defense attorney for C.R. Bard, Lori Cohen of Miami-based Greenberg Traurig LLP, asked Weber if she agreed prolapse was a vexing problem?
“Yes,” Weber responded.
“It can’t be made safe under every circumstance, true?” Cohen asked.
“That’s right,” Weber responded.
When asked if she thought McGinnis had primary stress urinary incontinence (SUI) and if an implant doctor should do what he or she thought best, Weber responded “as long as they have adequate information.”
Cohen referred to an earlier medical report Weber had collaborated on in which it was stated “TOT (bladder mesh) sling has become one of the most-popular and effective surgical treatments for female SUI worldwide.”
It was also stated in the report the effectiveness of such treatments was high.
“These were your words,” Cohen said.
“Yes,” Weber responded.
The report said complications from such procedures were common, but serious complications uncommon.