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Ethicon Media Monitoring 9/5/2017
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Doctors fight ‘crusade against vaginal mesh’
Sep 5, 2017 | The Australian
By Caroline Overington
A second Sydney surgeon has expressed concerns about the Senate inquiry into the use of vaginal mesh, describing it as “a crusade to prove that women have been experimented on by the medical profession, and anyone who disagrees is immediately shut down”. -
J&J Medical Expert – No Problems with TVT-SECUR
Sep 5, 2017 | Mesh Medical Device Newsdesk
Today the 5-week trial of mesh-injured plaintiff Ella Ebaugh, may wrap up with closing arguments (Case No. 130700866) in the Philadelphia Court of Common Pleas.
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Doctors fight ‘crusade against vaginal mesh’
Sep 5, 2017 | The Australian
By Caroline Overington
A second Sydney surgeon has expressed concerns about the Senate inquiry into the use of vaginal mesh, describing it as “a crusade to prove that women have been experimented on by the medical profession, and anyone who disagrees is immediately shut down”.
Darren Gold, a colorectal and pelvic reconstructive surgeon and a senior lecturer in surgery at the University of NSW, says surgeons who approve of mesh products to treat incontinence and prolapse have been “vilified, and in some cases, destroyed by the campaign against mesh”.
“I have tried to get a submission published on the Senate website, and it has not gone up and when I complained, they told me in an email to ‘soothe my nerves’,” he said. “It really is a snow job. People forget how many vested interests there are in medicine. Does somebody want to get rid of mesh? Are there people who just prefer to do hysterectomies on women, which in my view should never, ever be done to treat incontinence and prolapse?’’
The Senate investigation was initiated by senator Derryn Hinch, who has compared the use of mesh to treat vaginal prolapse with a scandal on the scale of Thalidomide. Senator Hinch says women were “treated like mushrooms” by the medical profession, with many suffering serious complications after having mesh inserted.
Dr Gold referred The Australian to a Sydney patient who wrote to Senator Hinch, offering to discuss the ways her life had improved since being treated with now-banned mesh products. She says she was “fobbed off” by a staff member who told her she was probably just “one of the lucky ones”.
In an email, one of Senator Hinch’s staff told the woman: “While I’m pleased you experienced such great results … I am afraid to say that I have heard and read MANY stories from ladies who have had the complete opposite experience. I cannot state strongly enough how overwhelmingly negative the stories I have heard or read about have been.’’
The Australian last week published concerns raised by one of Sydney’s most senior uro-gynaecological surgeons, Jenny King, director of the Pelvic Floor Unit at Sydney’s Westmead Hospital and chairwoman of the Urogynaecological Society of Australasia, who said she was alarmed by the “one-sided reporting on mesh”, which she described as “a godsend for many women”.
“I have tried to talk with multiple media outlets, but quite honestly no one wants to hear about ladies who have had a good outcome. Why don’t these patients matter?” Dr King said.
Dr Gold said the medical community was split between those who support mesh products, and those who decry them.
Dr Gold is a proponent of the work of an Australian professor of surgery, Peter Petros, who invented a mesh device that is no longer approved for use in Australia.
At least one of Professor Petros’s patients won more than $100,000 in damages after a failed operation left her with serious complications.
Dr Gold said the answer lay in better education.
“The current practice, where they put sheets of mesh around the bladder, vagina and rectum to hold them up, will never improve symptoms,” he said. “The ligaments have to be tightened. The organs have to work together. You can’t tie them down with mesh. That is the problem.”
http://www.theaustralian.com.au/national-affairs/health/doctors-fight-crusade-against-vaginal-mesh/news-story/59dfcbb8d056a5033064c960cdddd60f
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J&J Medical Expert – No Problems with TVT-SECUR
Sep 5, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, September 5, 2017 ~ Today the 5-week trial of mesh-injured plaintiff Ella Ebaugh, may wrap up with closing arguments (Case No. 130700866) in the Philadelphia Court of Common Pleas.
The following continues a series of insider reports into this, the sixth pelvic mesh trial in this court, which accuses Johnson & Johnson and its Ethicon division of manufacturing and selling defective pelvic mesh products , the TVT-SECUR (TVT-S) and the TVT (Tension-Free tape), implanted to treat stress urinary incontinence (SUI).
Two previous trials here have found the TVT-SECUR (TVT-S) defectively designed. Of the five previous, all but one has resulted in compensatory awards for the mesh-injured plaintiff totaling $48 million.
Last week, J&J, the maker of the TVT-SECUR and TVT (tension-free tape) implanted in Ms. Ella Ebaugh, brought its medical expert to the stand.
The dozen jurors, all African-American, were introduced to urogynecologist, Dr. Janet Tomezsko, from NorthShore University Health System in the Chicago area. She graduated medical school in 1991 attending both Penn State and Drexel.
Dr. Tomezsko trained at Christ Hospital during her residency with Ethicon flying her to study with Dr. Vincent Lucente, a consultant and preceptor for J&J from Allentown, Pennsylvania who has been cited in many of these cases as a the doctor whose job it was to bring new doctors into the J&J fold and train them on using the J&J pelvic meshes.
For his part, he was compensated millions of dollars.
The medical expert was questioned by Kat Gallagher, representing Johnson & Johnson.
Dr. Tomezsko examined Ella Ebaugh for the defense and was there to testify about the medical issues, not to give her opinion about the TVT or the TVT-SECUR. Ms. Ebaugh was implanted with both pelvic meshes to treat incontinence.
The medical expert received medical records, depositions in the case, medical expert reports, the literature and some company documents to write her report. Most of those are submitted by the defense team for the doctor’s review.
Dr. Tomezsko had been trained on the Burch procedure and fascial slings before the invention of the midurethral sling.
She called the Burch procedure very invasive because it involves a bikini cut incision of several inches and a three-day stay in the hospital. Later the Burch procedure was done through small holes, which was less invasive.
Compare that to a midurethral sling which is a 20-minute procedure where the patient can go right home. It was considered an enormous improvement for both patient and doctor.
Dr. Tomezsko is a published scientist in her field in peer reviewed journals. She takes occasional mission work trips to Bolivia where she uses the J&J TVT Retropubic sling on patients and teaches doctors there how to do the procedures.
“I really like the TVT product and I feel this is very easy to teach. It is so well proven. I feel very comfortable when I leave and go 4,000 miles away that I am leaving the patients in good hands with a good product.” ~ Dr. Janet Tomezsko, urogynecologist, consultant to J&J
Her current hospital has a contract with a different manufacturer of mid-urethral slings.
It is established by Ms. Gallagher that Dr. Tomezsko makes $400 an hour to review documents and $5,000 a day to appear at trial and testify. She has earned about $220,000 from Ethicon for work as a consultant on 16 cases and appearing at trial.
Kat Gallagher submitted to the court the qualifications of Dr. Tomezsko so that she should be considered an expert in the field.
Then it is the turn for the plaintiffs to question Dr. Tomezsko.
PLAINTIFFS CORRECT THE RECORD
Kline Specter’s Kila Baldwin for the Plaintiff continued with her line of questions.
First, a correction for the record.
The doctor received her certification in urogynecology in 2013, not 2008 as she had previously testified, Baldwin states. The doctor apologized for her earlier misstatement.
Baldwin establishes, through a series of questions, that Dr. T is not there to offer any opinions about the safety or efficacy of the TVT-S.
“Correct.”
Baldwin also establishes that Dr. T is not there to testify about the safety and efficacy of the TVT. “I am not here to give that opinion.”
Baldwin asks “Who decided which Ethicon documents to put on this list,” referring to the documents the doctor uses to form her expert opinion.
Gallagher: “Objection.”
The Court: “Overruled.”
Dr. T: “Those are the Ethicon documents that were provided to me from the attorneys.”
The list and reports were prepared by the attorneys for Johnson & Johnson, Baldwin establishes. The stack of documents grows tall on the witness stand. “I don’t think the Judge will mind if the stack gets too heavy for you,” says Baldwin.
Dr. Tomezsko does not use the TVT-SECUR (TVT-S) but does use the TVT in her practice today. She has implanted a TVT-S once or twice. She is listed as qualified in non-surgical treatment of TVT complications. Baldwin asks her if she is an expert in the removal of slings.
“Yes I am.”
“I have a wealth of knowledge regarding complications from multiple different procedures. I think in my experience I’ve only needed – I’ve only had one patient come to me who needed a complete midurethral sling removed. So it’s just not – it’s so uncommon.” ~ Dr. Janet Tomezsko
Baldwin establishes that Dr. T has only tried to remove one TVT device.
“That’s correct because it’s so infrequently necessary.”
Baldwin launches into a litany of other doctors who have had other experiences – Dr. Bruce Rosenzweig at Rush University in Chicago and Dr. M. Tom Margolis, a San Francisco area urogynecologist. Both have testified in numerous cases for the plaintiff that they have removed hundreds of midurethral slings.
Even the testimony of defense witness, Dr. Denise Elser, has included her experience with attempting to remove hundreds of midurethral slings.
Dr. T did not choose to examine Ms. Ebaugh bladder with a cystoscope, therefore she could not testify about the current state of scarring inside her urethra.
Dr. T says she is offering opinions based on her medical records of her treating physicians.
During her training with Dr. Lucente at Allentown, PA, she received a certification in Prolift pelvic floor repair system profession education in 2005 signed by Dr. Martin Weisberg, MD for Ethicon. Baldwin reveals an Ethicon e-mail about an upcoming two-day event dinner and proctorship which Dr. Tomezsko would attend in July, 2009.
Dr. Lucente steered her career toward urogynecology, “And he’s been my mentor ever since.”
Baldwin: “Do you know how much money he’s been paid by Ethicon?”
Gallagher: “Objection”
The Court: “Sustained”
Another Ethicon document read by Baldwin states, “Anyone who has ever trained with Dr. Lucente and, more importantly, has been unconditionally loyal to the first and best sling material on the market since its introduction, is invited to any event that we host in said trainee’s respective geography, “provided that loyalty still exists, exclamation point, exclamation point. Ha, exclamation point.”
With the jury out of the room the judge interrupts the proceedings.
His wife has informed him that his children have Johnson & Johnson stock, under about $9,000, probably given by their grandparents. Neither side raises any motions to object.
BLAME THE VICTIM
As part of any courtroom strategy it is necessary to deflect blame from the allegedly defective product. That task was address in the defense questions by Kat Gallagher.
Eubaugh had pain complaints before her mesh surgeries, she asked Dr. T.
Yes, the doctor answered, for example she has chronic back pain that radiates down her left leg, and a charlie horse in her lower abdominal muscles. She experiences abdominal cramps that double her over with pain, fatigue and malaise.
Dr. T said that suggests an electrolyte imbalance or myopathy, where something is wrong with the muscle. Ms. Ebaugh complained about headaches.
Recall earlier it was revealed before this jury that Ms. Eubaugh had to undergo a hip implant. She had been a national championship softball player but there was no history of trauma to the body. There was a history of osteoarthritis from wear and tear. She tested positive for leukocytes and blood in her urine, consistent with patients who are potentially having urinary tract infections. She had a strong sense of urgency to urinate and SUI (stress urinary incontinence).
Dr. T says this is consistent with the condition of overactive bladder.
Midurethral slings are not designed to treat urge incontinence or overactive bladder, she confirms.
As a treatment, Dr Douglass did urethral dilation or stretching, using instruments to stretch the urethra open. Ms. Ebaugh underwent pelvic floor physical therapy and she was placed on Enablix medication to treat overactive bladder, which did not help much. He increases her dosage from 7.5 to 15 milligrams.
Eventually she had a TVT-Secur, though Dr. Tomazsko does not implant those. The doctor had no criticism of Dr. Douglass or his surgery. TVT-S did not stop Ms. Ebaugh’s SUI. He then offered her the TVT. ###
https://www.meshmedicaldevicenewsdesk.com/jj-medical-expert-no-problems-tvt-secur/
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