Boston Scientific Day Two: The Problem with Pinnacle and Polypropylene
In this second day of a federal product liability trial of four women implanted with the Pinnacle Pelvic Mesh Kit, polypropylene (PP) was on the stand as well as the Boston Scientific (BSC).
Marlex was the name of the BSC polypropylene mesh. The raw material is supplied by the petroleum company, Chevron Phillips, which supplies polypropylene (PP), a polymer, to industry for many uses from Tic Tac box tops to pelvic mesh.
Chevron changed the way it made its PP over time said Dr. Jimmy Mays, a polymer chemistry professor from the University of Tennessee.
It also added a warning for anyone coming in contact with the potentially toxic polymer. The Material Safety Data Sheet is required by OSHA (Occupational Safety and Health Administration) to accompany any potentially harmful substance that is handled in the workplace or could present a hazard to local fire and emergency planning officials.
As has been shown in the case of C.R. Bard (Cisson), the MSDS carries an explicit warning. In response, Bard created a dummy company to purchase the raw PP resin, in hopes of bypassing any suspicions the material was being used to make medical devices, a move that was exposed during the Cisson trial. The MSDS warning says:
“Do not use this Chevron Phillips chemical material in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from Chevron Phillips chemical under a contract which expressly acknowledges the contemplated use.”
Court documents show the company thought “it was more of a legal kind of cover your liabilities thing than anything based on science.”
Did the company have this MSDS by January 2008 when it launched the Pinnacle? Yes it did, said Dr. Mays adding the responsibility then fell on BSC.
“If you put this in as a permanent implant in the human body, you’ve got to make sure the material will remain intact for a lifetime of the person.” ~ Jimmy Mays, PhD
The warning language remained the same in 2004 to 2008. Pinnacle was made by the company in January 2008.
Like a Fishing Line
The court was shown a journal article by A. Clave “Polypropylene as a reinforcement in pelvic surgery is not inert: comparative analysis of 100 explants. March 2010 (here).
This was the first study to evaluate synthetic implants used in a vaginal approach for pelvic floor reinforcement. While previously considered inert, PP is associated with high complication rates and the study suggests the need for clinical trials comparatively.
Mays told the jury this study says not all PP degrades in the same way and may have a different effect on different women.
The body attacks it and keeps attacking it through a strong effect of mineral acids and oxidative action that will eventually lead to embrittlement, he said. For polypropylene (Marlex) that meant “as you remove the flexible part by oxidation you leave the stiffer part behind.”
Adding to that explanation he said “As the oxidative degradation takes place mesh becomes stiffer and can’t move the way its designed to move, like fishing line that will cut your finger. So it can no longer move with the tissue and causes a sawing effect and I believe that’s what causing problems with mesh.”
Plaintiff attorney Jim Perdue asked if there is a way to test if PP is the appropriate material to use as a permanent medical device? “You have to test it in humans,” Mays said.
On Cross examination, Hildy Sastre ( Shook Hardy & Bacon) established that Dr. Mays had never made a presentation on mesh and had done no research on polypropylene and its effects on the human body before this litigation.
“You’re not a surgeon, not a doctor, a urogynecologist, you’re not an expert in the human body response to Polypropylene mesh after its explanted?
“I understand the body has a strongly oxidative environment. I can read and I can see from the literature that the body attacks polypropylene,” Mays replied unshaken. “It is my opinion, polypropylene is not a suitable as a permanent mesh implant.”
The Standard of Care
The lawyer brought out the Position Statement from AUGS (American Urogynecologic Society), a medical society with long tentacles in medical device manufacturers that sponsor their annual meetings.
Often shown to juries in these trials, the AUGS statement says “Polypropylene mesh mid-urethral sling is recognized at the standard of care for treating stress urinary incontinence. The procedure is safe and effective and improves the quality of life for millions of women.”
The problem with that argument though is that the Pinnacle is not a mid-urethral sling (used to treat incontinence or SUI), but the largest of all mesh kits used to treat pelvic organ prolapse (POP).
Pinnacle was voluntarily recalled May 2011, three years after it was launched, after a growing body of adverse events or complications were coming in. That voluntary recall is not something the jury is not allowed to hear in this case as both sides have agreed to motions to limit the scope of the trial.
Pointing to a 2008 study by AJ Woodruff, (here) which indicates no mesh degraded in 24 women who underwent a sling revision and had their mesh analyzed. The grafts were explanted at 2 to 34 months after implantation. Ten women had a PP mesh implant. “No degradation of the mesh material had occurred with time,”
While Boston Scientific had implanted PP mesh in the abdomens of rabbits that were sacrificed in stages to determine the effect on the mesh, it had never been tested in randomized controlled clinical trials to find the effects on the human body prior to the launch of the Pinnacle.
Unlike the case of Jo Husky or Donna Cisson who had supportive partners offering comfort during their pelvic mesh trials, the four female plaintiffs have been sitting quietly and together behind the lawyers table in the enormous courtroom. None of them appear to have any family members in the courtroom for support. Two are Spanish speakers and require a translator. All are from Florida.
Margarita Dortes is the youngest. She was implanted October 8, 2010 with the Pinnacle Pelvic Mesh Kit at Palmetto General Hospital in Hialeah, Florida by surgeon Dr. Emery M. Salom. She is a client of Blasingame, Burch, Garrard and Ashley of Athens, Georgia. Gary B. Blasingame has been in the courtroom to lend her support.
Originally from Cuba, she is in her early 40’s and has two sons. She’s had one partial revision and is scheduled to receive another revision surgery with Dr. Willy Davila in December.
Testifying she was quiet and low key. There were no tears or show of emotion and Dortes had some trouble explaining herself in clear English. She had been informed of the risks specific to the Pinnacle, the risk of erosion but not the risks of permanent and severe pain.
On cross examination, Hildy Sastre said she meant no disrespect but nonetheless brought out that Dortes didn’t tell her doctors about her pain. Indicating Dortes was seeking emotional damages in this litigation, she gently prodded that Dortes had had problems with self esteem, stress and anxiety all of her life.
Dortes was firm she felt today, “Like a different person who isn’t normal anymore.”
The VP of Research and Development of the Division of Urology and Women’s Health appeared before the jurors by videotape. Alfred Intoccia spoke quickly and confidently and in regulatory and sales lingo. Of course a material should be tested before use, he said. Profits should not be put over patient safety.
Internal company documents were shown to the court from marketing and sales.
“Be first to market. Timing and marketing is the most critical measure of long-term business success.”
While the jurors cannot hear the Pinnacle is no longer on the market, Intoccia was asked if he understood the earliest pelvic mesh created, the ProteGen, was removed from the market. After that failure, BSC wanted to make it into a teaching moment. In conjunction with any future sling materials, the company planned to gather clinical data to assess how the product performs in a broad spectrum of clinical situation before it placed the new device on the market.
But making that call was the responsibility of the clinical division, not R&D, he said.
Instead BSC tested the PP in a cadaveric lab, said Intoccia. “We learned a lot.”#
FDA URGENT MEDICAL DEVICE RECALL, May 2011, Pinnacle Pelvic Mesh Kit