Jury Reacts to Minimally Invasive Transvaginal Mesh Procedure
This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated.
The second day of the Huskey v Ethicon trial commenced with Dr. Bruce Rosenzweig on the stand for a second day. Monday he was established as an expert in the case. The urogynecologist with Rush University Medical Center in Chicago is in private practice where he used to use TVT (transvaginal tape) in his practice.
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That was after he was chosen among an elite group of doctors who were flown by Ethicon, a division of Johnson & Johnson, to Belgium to attend a cadaver clinic to learn and eventually promote the use of TVT.
But Dr. Rosenzweig told jurors after about 15 to 20 TVT implants and 40 TVT-O implants he stopped using the polypropylene mesh. Instead he turned to the burch procedure which involves using sutures to hold up a sagging urethra. He also removes mesh and has now explanted about 200 TVTs from women with complications and about 1,000 mesh explants of all types of mesh.
One of Huskey’s attorneys, Jeff Kuntz (Wagstaff Cartmell), showed Dr. Rosenzweig a box containing the mesh kit – a TVT-O complete with stainless steel trocars.
Mrs. Huskey was implanted with the TVT-O to treat her incontinence in February 2011. Since then she has experienced chronic pelvic pain and dyspareunia and following one attempted explant surgery, the majority of the mesh remains behind. Unlike four versions of their transvaginal mesh products used to treat incontinence and prolapse which have been removed from the market, the TVT and TVT-O are still sold.
Presenting documents to the doctor, Kuntz showed Rosenzweig a document, an email from within the division of Johnson & Johnson responsible for creating the TVT-O in 2003. The group on the TVT-O Project said it normally took 24 months to launch a new product. In this case, because competitors were “stealing” their design for the TVT (transvaginal tape), the employees would launch instead in nine months, a new record for getting a product to market.
“To protect our market share we have to be prepared to launch without requiring clinicals” the email said, referring to clinical trials on human subjects to test for safety and efficacy.
Next attorney Kuntz showed the jury of nine, including seven women, a video of an actual surgery implanting a TVT-O tape. The camera was honed right on the surgical site while Dr. Rosenzweig narrated the graphic scene, too graphic to show here.
“What the video shows is an incision inside the vagina with the helical passer into the vagina and into a muscle structure which is the obturator foramen.” The polypropylene tape must be inserted through an incision in the vagina and passes through two pre-set exit points.
At that point one of the jurors indicated she had a problem. Visibly shaken and bent over, the judge called for a recess and the bailiff helped guide her from the jury box along with the other jurors. She appeared pale and gagged twice while being led out of the courtroom.
The TVT-O implantation is still marketed by Ethicon as a “minimally invasive” procedure.
Would this juror return? After a brief recess, all nine jurors came back into the courtroom and Dr. Rosenzweig continued, without the video, telling them that in his practice he is seeing complications that are severe and life-altering including chronic and persistent pain, muscle and nerve injury, pelvic pain, pelvic muscle spasm and chronic erosions. To make matters worse, in many situations he is not able to remove the entire device. #