Day 9 Linda Gross v. Ethicon, What Did Doctor Know Before Implanting Prolift?Jan 23rd, 2013 | By Jane Akre | Category: Legal News
January 23, 2013 ~ Much thanks to Courtroom View Network for access to the live court proceedings and graphics shown to the jury.
There was no live person on the stand on Day 9 on Linda Gross v. Ethicon trial.
The proceedings began in the afternoon when the jury was shown a videotaped deposition of Dr. Kevin Benson of Sioux Falls, South Dakota.
The urogynecologist specializes in female pelvic reconstructive surgery and it was Dr. Benson who implanted the Ethicon Prolift transvaginal mesh in Linda Gross in July of 2006.
His deposition focused on the factors behind the decision to use Prolift and whether Dr. Benson had enough information supplied by Ethicon, a division of Johnson & Johnson to make a fully informed decision.
The plaintiff, Linda Gross and her attorneys claim that neither patient nor doctors were informed about the risks of the untested Prolift, risks Ethicon knew in advance of selling the defective polypropylene mesh.
Linda Gross, then age 41, went to see Dr. Benson for an evaluation in June 2006. She had had three children and two difficult pregnancies. With no complaints about urinary function she did have problems defecating.
A bulge from her rectum was intruding into her vagina which made it difficult to pass stool. Only when she used her fingers pushing the back of her vagina could she make her body work as it was supposed to. A rectocele repair, as it’s called, requires a reinforcement of the back wall of the vagina.
At the time her options would be a tradition suture repair, watchful waiting or the use of mesh.
Dr. Benson seemed a bit hostile when questioned by Gross’ attorney Adam Slater on tape. To admit he made the wrong choice also questioned his credentials.
Dr. Benson said he worked with Ethicon as one of the doctors the company used to train other doctors on the Prolift procedure.
Slater questioned whether Dr. Benson had been given enough information for his patients to give a fully informed consent, a follow up to yesterday’s testimony by Dr. Peggy Pence who told jurors that Ethicon did not reveal enough critical information to doctors.
Slater: “You would assume whatever was put in the IFU (instructions for use) would be a complete statement of what you would need to know?”
Benson: “I would assume so.”
Slater: “And the risks would be listed in the IFU?”
Dr. Benson used the Prolift to correct Gross’ rectocele primarily because she had compromised tissue from a prior suture repair and additional prolapse in two compartments.
The mesh implant may have stopped the rectal prolapse but the pain was unbearable and Ms. Gross returned to Dr. Benson in monthly intervals complaining of chronic pain on a scale of 5 to 10.
Dr. Benson said that since 2006 he’s learned some patients are “sensitized to pain” and any type of insult or surgery may cause a reaction that is out of the ordinary. So unusual that he said since 2006 Dr. Benson has not had any other patients with the same reaction to mesh as Linda Gross.
Almost immediately after surgery Gross returned to Dr. Benson to explain she was having pain at the trocar site where the instruments in the Prolift kit cut into her groin area and at the arms of the Prolift used to secure the implant into ligaments.
Linda wanted the mesh removed and Dr. Benson performed several surgeries. During one he found a small mesh extrusion about the size of a dime showing in the vagina which he removed.
“The mesh was flat,” he said, “It contracted. It shrunk over time.” Dr. Benson then performed another mesh removal surgery in December 2006 because “Linda had a strong desire to have it removed.” A portion of the wings were not removed that exit the vagina.
When the next generation of Prolift mesh was created, the Prolift +M which did receive FDA approval in 2008, Dr. Benson said he switched over “to have less mesh burden.”
The Prolift+M was lighter and might present less mesh for a patient to react to.
The newer Prolift +M also used the Ultrapro mesh, the same mesh French doctors urged Ethicon to switch to prior to the launch of Prolift. In order to stay on track with its predicted March 2005 launch, Ethicon never made the switch.
Dr. Benson testified said as a result of the Linda Gross outcome, his discussions with patients have become “more robust over time.” Today he spends at least two 45 minute sessions with a patient contemplating a mesh implant.
Usually he follows the patient’s wishes but “I also think it’s important they have as much information as we have to make a decision.”
Today would he have made the decision to use the Prolift mesh on Linda Gross?
Dr. Benson said today he would choose a suture repair, especially in a sexually active 41-year-old.
Learning from experience, Dr. Benson also admitted he rarely does additional surgery on a patient experiencing pelvic pain, but the doctor added he still believes the risk from mesh is still low, “in the single digits.”
“I think erosion still occurs today but has gone down because of the dissection techniques and we are more familiar with how the material acts.”
Slater:”Do you feel you knowledge base has expanded since you treated Linda?”
The urogynecologist elaborated that since 2006, the year of Linda Gross’ surgery, the medical community has learned how women heal and their nervous system response to “insult” in this case the insult of surgery and mesh implantation.
“Primitive nerve fibers interact in the brain centers that deal with pain,” he explained, “it is no longer an end organ issue, it’s more of a centralized issue or phenomena.”
Dr. Benson admitted that some individuals react more than others to a foreign body implant and to pain and that is not completely understood.
“Triggers that may not be triggers under normal circumstances for other people may be for that person.”
Also not understood is whether removing the material provides improvement or relief from the pain.
“Some patients have explantation of mesh and are completely resolved. Most of the time patients do see improvement. At this point there is not a clear understanding if that is always the case,” said the doctor.
Based on the knowledge he has today Dr. Benson said he is not choosing mesh for primary repair of a posterior prolapse. But at the time, with a patient who had the prolapse of three different compartments, compromised pelvic tissue and with the knowledge the company supplied, mesh was the best option.
Under Cross exam with an attorney for Ethicon Dr. Benson admitted he didn’t consider an abdominal sacrocolpopexy in Ms. Gross because it doesn’t address a rectocele and it represents a risk of erosion, pudendal nerve and artery damage.
Besides, in 2006 he was focusing more on mesh surgeries and in teaching other doctors how to use Prolift after specialty training provided by Ethicon.
She showed him the Surgical Guide that surgeons would have received from Ethicon in 2006. It included “infection potentiation, fistula formation, erosion, extrusion and scarring results” possible with a mesh implant, information the company did supply to surgeons.
Q: “Did this factor into our treatment with Ms. Gross?”
With answers all over the board both sides fired questions to Dr. Benson as his deposition wrapped up.
Adam Slater asked Benson, “They didn’t share information about using Prolift in patients with chronic pain in 2006?
Slater: “If you knew then what you’ve learned in years since, your discussion with her would have been very different in July ’06 right?
Slater: “You would have given a much more extensive explanation of risks of using the Prolift?
Slater: “You said earlier you are not choosing mesh for repair of posterior prolapse in sexually active 41 yr old woman.
Benson: “Yes that’s correct. The issue with someone with apical and anterior prolapse goes beyond an isolated rectocele. With an isolated rectocele I’m choosing suture colporrhaphy unless they have recurrence of that compartment.”
And he added, “Right now data on whether mesh is advantageous over suture repair in the posterior compartment for an isolated defect has yet to be proven.”
In summary Slater wanted to make a point. “If Ethicon knew on the day the Prolift was launched what happened to Linda was something that could happen to women with the Prolift, they certainly didn’t warn about it?