Do the mesh arms of the Prolift rope and curl?
Dr. Bruce A. Rosenzweig, a gynecologist and urinary tract specialist with the Rush University Medical Center in Chicago, described for the court what happens when pelvic mesh inside a woman’s body deforms.
“Does mesh deformation lead to complications?” attorneys for the state asked.
“Yes,” Rosenzweig said. “Mesh can rope and curl; it can fold its edges and fray off (into particles).”
The result, Rosenzweig said, can be acute pain in the groin.
The trial in the San Diego County Superior Court is being streamed live courtesy of Courtroom View Network.
When asked about the impact of what is called “roping” by the mesh, Rosenzweig said a narrowing of the mesh makes it difficult to urinate and creates increased pressure under the urethra.
An exhibited slide said an 8.5 percent change in the weight of the mesh can result once implanted and photos showed cracking of the vaginal sling.
“It (sling) can become stiffened, hardened, brittle,” Rosenzweig said. “It leads to chronic pain and pain during intercourse.”
Erosion of the mesh in the vaginal tissue can lead to scar plating and contraction of the mesh, Rosenzweig explained. He agreed that polypropylene is not an inert substance---it has the ability to degrade and change inside the body.
“Does the roping lead to harm in women?” he was asked.
“Yes,” Rosenzweig said.
“What is the most common symptom?”
Defense experts have testified that the mesh arms that end up in the pelvic cavity lie flat, and do not rope or curl.
Plaintiff’s expert and the scientific project lead for the Prolift, Mr. Scott Ciarrocca, who is currently employed by Ethicon, testified that the mesh has a larger diameter and must pass through cannulas having a smaller diameter and hence must, by virtue of this, rope and curl.
The pelvic and groin pain results from curling and roping mesh. This is evidence that supports a defective design product liability claim.
Dr. Khandwala said the arms lay flat in the tissue, in contraction to what Mr. Ciarrocca said.
Mr. Ciarrocca testified that it is impossible because the mesh is wider than the cannulas.
Dr. Khandwala said some of the mesh lays flat in the cavity, and another part does not lay flat.
According to the Plaintiff’s expert there is a roping of the arms. A roping and curling of the mesh arms of the Prolift is what is causing Ms. Dunfee's pelvic pain problems.
Defendants did not call any expert to testify that had examined Ms. Dunfee to contradict this.
Plaintiff’s counsel, during cross examination of Dr. Khandwala, asked him to perform the Prolift implant procedure using a plastic mold model he had brought to show the jury. When Plaintiff’s counsel asked Dr. Khandwala to remove the cannulas 45 minutes later, presumably the mesh had rolled and curled. Attorney Tom Kline asked the jury to look at the mesh in the model as they left the jury box.
Dr. Khandwala pointed out that the cannulas are never left in the body during the procedure for 45 minutes, he testified that the entire procedure takes that long, and most of that time is the preparation before the cannulas and mesh are even inserted.
The contradiction in testimony is that the mesh must curl and rope since the mesh diameter exceeds the diameter of the cannulas, whereas Dr. Khandwala testified that the mesh left in the cavity lays flat.
Dr. Bruce Rosenzweig
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