Blog: Observations from Suzanne Emmett Pelvic Mesh Trial
The trial is held in Courtroom 275 of the Philadelphia Court of Common Pleas, Judge Kenneth J. Powell, presiding.
Plaintiff Opening Statement
One of the products at issue in this case is called “Prolift,” which is supposed to support weak tissues in the pelvic floor, and to relieve symptoms from pelvic organ prolapse, aka “POP.”
Some of the complications from the Prolift which Suzanne Emmett experienced are:
•multiple erosions where the mesh lacerated, perforated and sawed into her vagina,
•scarring (aka fibrosis, scar plating),
•vaginal deformation (when mesh contracts it can entrap nerves causing pain), and
Did the implanting doctor violate the standard of care and industry standards by using defective medical devices? The implanting doctor was Dr. Patricia Reddy. No claims were brought by Suzanne Emmett against Dr. Reddy.
The standard of care is Plaintiff’s burden, to articulate and prove it was not met.
The main trial attorney defending J & J and Ethicon, the manufacturers of the mesh, is Mr. Tarek Ismail, a partner of the Chicago based law firm of Goldman, Ismail, Tomaselli, Brennan & Baum.
Plaintiff claims she was irreparably harmed when Prolift and Gynamesh -- used to repair anterior (front) and posterior (rear) prolapse -- sawed through and exposed in her vagina 14 different times, requiring 9 different erosion surgeries to extract the eroded mesh piece by piece.
The mesh caused inflamed tissue, and chemically burned her vagina.
She cannot have sex anymore.
She suffers from bladder spasms -- at times similar to the pain women experience during child birth.
She has these painful spasms 5-6 times per night, and sometimes feels as if she were birthing a baby.
She loses the contents of her bladder, wears a diaper and black pants every day since her mesh implants.
The other product implanted was a TVT-O -- aka TVT Obturator, because it is implanted in an inside out procedure, passing the TVT-O mesh sling through her obturator foramen. The sling is used to support her urethra to cure her stress urinary incontinence (aka “SUI”), which occurs when she coughs, sneezes, walks or does any type of exercise or physical activity.
The theories of liability are:
•Failure to give adequate warnings,
•Conscious disregard of known risks – company emails and sales materials evidence what the manufacturers knew; J & J and Ethicon put defective products on the market knowing that they would harm women.
The need for prolapse repair occurs when connective tissues stretch and sag in the vagina, which sometimes occurs from child birth. Plaintiff’s son born 21 years before her mesh implant was over 10 lbs. when he was born, and her daughter was over 8 lbs. when she was born. Large babies and vaginal births have been known to cause symptoms from pelvic organ prolapse.
However, in Plaintiff’s case, her prolapse was asymptomatic and was not causing her any problems at the time that Dr. Reddy recommended that she have Prolift and Gynamesh implanted to help cure her pelvic organ prolapse.
The mesh implant surgery was a major invasive surgical procedure, the surgeon dissected through tissue in front of Plaintiff’s bladder.
The type of material used is polypropylene plastic mesh which is constructed similar to a basketball net, and was used to lift Plaintiff’s bladder off of her vagina.
The posterior prolapse repair was performed to lift Plaintiff’s rectum off of her vagina, the tissue was dissected in the back wall of her vagina and Gynamesh was placed to maintain space between her rectum and her vagina.
The surgeon diagnosed Plaintiff’s urethra as being hypermobile and that she suffered from an intrinsic sphincter deficiency, which was causing her stress urinary incontinence.
At the time of her mesh implants Suzanne Emmett was dripping urine almost every day, and she had to wear light pads.
The TVT-O mesh sling implant was passed through the obturator foramen space – this was a major invasive surgical procedure. The tissue near her obturator was dissected and the mesh was looped through her obturator foramen space.
The pore size – relating to the size of the space between the mesh strands – was small. You need larger pore size so the mesh can grow between the mesh pores so it can integrate with the tissue. Because of small mesh pore size there was bridging fibrosis and scar plating, which encapsulated the mesh, causing the mesh to contract. Since the tissue could not grow between the small pores, dense, hard scar tissue formed around the mesh, which makes the area not capable of stretching.
The vagina needs to be elastic and flexible to stretch to accommodate the size of a baby or a man’s penis during sex.
The bladder also needs to be capable of stretching to hold the urine and contract so the urine can pass out. The rectum needs to be capable of stretching to contain the feces.
Because of the hard tissue and scarring, causing the mesh to contract, Plaintiff suffered pain and nerve entrapment.
When the scar tissue contracts, the mesh contracts along with it, and ends up rolling or folding, or crumpling up like a potato chip.
The mesh contracts to approximately 30% of its original size.
This prevents the vagina, rectum and bladder from being able to expand and contract and to perform normally, the way they are supposed to function.
The erosions Suzanne Emmett experienced occurred when the mesh sawed through and entered her vagina, this is also known as an exposure.
When the nerve endings are trapped this causes pain.
Bacteria is trapped in the small mesh pores, and this makes Suzanne Emmett suffer from frequent urinary tract infections and inflammation. There is a foreign body reaction which is chronic and never ending, where the body never stops fighting the foreign plastic substance inside the pelvic area and vagina.
If it were a few small sutures of polypropylene the foreign body reaction would not be a big deal, the more mesh the more foreign body reaction.
The total Prolift mesh is 260 yards or 780 feet – Ms. Emmett did not receive a total Prolift, the surgeon cut what she believed was the right amount of mesh needed to correct Ms. Emmett’s rectal prolapse. She used 90 feet of polypropylene, which is almost 500 feet, the size of a football field, and that is not counting the Gynamesh.
The mesh cannot be safely removed in total – it is a permanent implant.
The Prolift was introduced to the market in 2005 and was withdrawn from the market voluntarily in 2012. In 2002 the Gynamesh was introduced to the market, and was later pulled off the market because of bad side effects, it is no longer used in vaginal applications.
Other options are the Burch native tissue repairs procedure, and Raz Needle Suspension.
Burch colposuspension is effective in stress urinary incontinence in women without simultaneous uterovaginal descent.
Using biologic grafts from cadavers or animals do not cause any foreign body response.
Bulking agents could be used to support the prolapsed organs – which is better than shrink wrapping pelvic organs with mesh.
There is a risk of recurrence of the stress urinary incontinence.
There is no permanent painful sex as when using mesh, just during post-op period following a surgical procedure using native tissue or biologic grafts.
The best mesh is no mesh.
The TVT was described as a cash cow for J & J and Ethicon. The Prolift was expected to generate review of $300 million. The TVT expected to generate $60 billion.
The mesh implants were described as experimental, and there was no need for the products as other safer procedures were available.
Defendants paid $20 million to Professor Olmstead to use his mesh designs for TVT products.
Internal company documents described the weak point was the polypropylene plastic mesh. The company internal documents show doctors suggesting to stop selling and do more testing.
The Defendants paid for good results on what testing was performed.
The IFU (information for use) product brochure does not state that there is a difficulty removing eroded mesh, surgeons need to use an electric knife to try to remove the eroded mesh in pieces.
Professor De Laval did not test the TVT products on women, it took 9 months from start to finish before TVT was introduced to market.
Axel Arnon said the mesh was over designed and that lighter mesh was needed, he said the mesh was too heavy and that it would cause erosions to be very common. The mesh gets very hard as a rock, and rolls like a potato chip.
An alternative material was Ultrapro – a disappearing suture. In 2005 it was less expensive, it was a pricing point, Defendants could make more money selling a mesh implant made from polypropylene. Vicro had a 17% erosion rate, which was too high. The Prolift had a 33% complications rate, and a 19% erosion rate. It was sold for 7 years before Defendants removed it from the market.
The complication of anatomical distortion of the vagina – was not mentioned as a risk warning in the product IFU. An internal company document states that the doctor at Ethicon would not want the mesh implanted in his own wife.
Ethicon paid Dr. Lucente, the doctor who performed erosion surgeries on Suzanne Emmett, $2 million dollars. Dr. Lucente was a paid consultant. In return for being paid millions by mesh manufacturers he opined that the mesh implants are the “gold standard” for treatment of SUI.
Professional societies were paid off by Ethicon.
In 2006, Suzanne Emmett was diagnosed with intrinsic spincter deficiency and SUI – which are not life threatening conditions.
Her children were born in 1986 (son) and in 1992 (daughter).
Dr. Ready found prolapse in all 4 compartments, although they were asymptomatic at the time of diagnosis.
In 2007, Dr. Ready took out Ms. Emmett’s uterus, and implanted TVT-O for SUI, and Prolift and Gynamesh to treat anterior and posterior pelvic organ prolapse.
She had her first mesh erosion surgery on August 1, 2007, and her second erosion surgery on October 10, 2007. The mesh was found to be bunched up when it was removed in part.
She developed urge incontinence, and lost the entire contents of her bladder, something that had not occurred prior to her mesh implants.
In 2009, the mesh eroded in two different locations in her vagina.
In 2011, the mesh eroded into her anterior vagina and posterior vagina.
She had to have chemical cauterizations to treat granulation tissue, which occurs when the mesh is eroding.
Silver nitrate was used for the chemical cauterization. She also had Botox injected into her bladder, and electrical shocks up her leg, which only provided a temporary fix.
Dr. Patricia Reddy had 5 trainings with Ethicon, and believed the risks of the mesh were temporary and could be treated.
Suzanne Emmett went to her doctors repeatedly and was never told by any of them that her mesh was defective.
Dr. Lucente told her it was not the mesh causing her complications – such as painful bladder spasms.
Plaintiff’s medical conditions include high cholesterol, high blood pressure, diarrhea, diverticulitis, constipation. She had atrophy for a few years, and regularly used estrogen cream for that, which resolved the atrophy.
Her erosions were not near her hysterectomy scar.
She travelled to Ireland, and abroad for her work.
Dr. Tom Margolis, Plaintiff’s expert, was paid $600,000 for his testimony and for reviewing medical records, etc. in various cases he has worked on.
Defendant’s expert elected not to examine Ms. Emmett, Dr. Margolis examined her.
Defense Opening Statement
Ms. Emmett had multiple medical problems, the mesh worked to fix her problems for 11 years.
She was warned of the risks. None of her treating doctors said her complications were caused by the mesh.
In 2007, Ms. Emmett had extensive surgery, 6 different procedures.
She had injuries and POP from having delivered two large babies.
Her vaginal births of large babies weakened and damaged her pelvic floor.
Her son was 10 lbs. and 12 ounces. She had to have stitches after he was born. Her daughter weighed 9 lbs. at birth.
SUI results from increased pressure in the abdomen – when she bends over and lifts groceries, when dancing.
Ms. Emmett suffered from chronic SUI for 20 years, had bad leakage which interfered with her activities and adversely affected her quality of life. She had problems with defecation because of a lax anal sphincter.
Dr. Reddy, a pelvic floor surgeon in Harrisburg, is not connected with Ethicon.
She found multiple organs pushing on Plaintiff’s vagina, bladder prolapse (front of pelvic floor), urethra weak and falling into her vagina, intrinsic sphincter deficiency, her urethra could not hold back her urine, her rectum was passing into her vagina, she had damage to the back of her pelvic floor.
Her uterus was falling down and creating a bulge into her vagina.
All the risks were explained to her including mesh exposure, chronic pain with sex, chronic pelvic pain;
In July of 2006 she took a family vacation to Mexico.
She works handling workers’ compensation cases since 1988, she is a company vice president.
At the time of her implants she was 45 years old, she had been wearing pads daily for decades, and suffered from fecal leakage.
Plaintiff had 6 different procedures using 3 different mesh products, her doctor thought the mesh was the best option for her, and had been used by Dr. Reddy in hundreds of patients previously.
The suture repair was not as durable, she didn’t want the procedure to fail within a few years. Dr. Reddy had success with the mesh, and very few complications, it was durable, effective and safe, but it was not free of complications.
Complications are not the same as a defect of the product.
The hysterectomy Plaintiff had has all the same risks as the mesh except for mesh exposure.
The vast majority of women treated with mesh have no erosion.
Her mesh surgery was May 16, 2007. She was told to rest, refrain from sex and heavy lifting. In June of 2007 she felt very good. She flew to Maine for her job.
She had her first mesh exposure 6/26/2007.
She took a 2-week trip to Ireland. Her mesh erosion got worse.
She had exposed mesh removed 8/1/2007. The end of Aug. 2007 she had a larger mesh exposure in the same place. She was referred to Dr. Vincent Lucente. On 9/12/2007 he removed a 3 x 1 cm piece of eroded mesh.
On 10/9/2007 she had more eroded mesh removed.
Dr. Lucente treated her for 8 years, told Plaintiff mesh was not defective and only removed exposed mesh.
She was treated with silver nitrate and had Botox injections and electrical nerve stimulation, to treat her overactive bladder and urge incontinence.
She was aging and losing estrogen.
Plaintiff traveled to London 10 times for her job, and made trips to Disney with her granddaughter. Plaintiff is relatively healthy as of 2018, in Plaintiff’s own words.
She has not criticized her doctors, her doctors have not criticized the mesh or called it defective.
Dr. Margolis destroyed some of his invoices. He examined Plaintiff twice in April of 2018, 5 years after Plaintiff filed her lawsuit.
Dr. Elliot, Plaintiff’s expert, makes money on the side by testifying for plaintiffs in pelvic mesh cases.
Dr. Bruce Rosensweig, another Plaintiff expert, made $1.5 million on plaintiff litigation, and did not review any of her records.
You cannot eliminate risks of pelvic floor surgery, there is no perfect solution. The mesh surgery is only performed by doctors experienced in pelvic floor surgery and anatomy.
With native tissue repairs, using already damaged tissue, this procedure fails half the time.
Using autologous strip of tissue from the thigh or abdomen, this is an invasive procedure and there is a long recovery time.
Mid-urethral slings hold up the urethra, the TVT-O was placed in a Hammock style U-shape, procedure took less than 30 minutes.
Plaintiff was hospitalized for 2 nights because many procedures were performed. The mesh used has an acceptable risk profile. The benefits outweigh the risks, it is a first line approach to treat SUI and POP.
The products used were tested on between 500 and 800 women.
Ethicon was not hiding the ball, included risks in IFU, and risks known by surgeons from medical school, residency, Dr. Reddy kept up with the medical literature.
Dr. Reddy’s results have been fabulous.
Plaintiff will show “cherry picked” marketing materials and presentations.
The mesh products were vigorously discussed and the Defendants discussed ways of improving the products.
There were over 2,000 studies.
There are emails from the company; Marty Weisberg, a company employee, apologized for joking that having sex with a woman with mesh was like having sex with a wire brush.
He and Ethicon want to do better and improve women’s health.
The case was brought too late; in 2007 Plaintiff already had multiple erosion surgeries. Her husband stated that having sex with Plaintiff in 2009 felt like he was stabbed on barbed wire.
Plaintiff knew she had problems, she knew well before seeing an attorney ad on television.
Dr. Lucente stated the mesh was not bad, but she filed a lawsuit any way.
Memories fade, there are changes in medicine and science. She filed a lawsuit 6 years after her mesh implant surgery.
There are no defects in the mesh that caused her complications. Her claims are time barred.
End of Opening Statements; Next Blog will be Examination of Plaintiff's expert, Dr. Thomas Margolis.