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Ethicon 10/28
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‘It was the worst mistake I ever made’
Oct 27, 2015 | Portsmouth News
After having four babies in five years, Dawn Martin, like many thousands of women, began to suffer stress incontinence as she got older. -
What is AkinMears hiding from Judge Joseph Goodwin?
Oct 27, 2015 | The West Virginia Record
As he presides over seven Multi District Litigation cases in Charleston involving more than 80,000 claims against manufacturers of transvaginal surgical mesh, U.S. District Judge Joseph Goodwin might want to keep a close eye on one plaintiffs firm in particular. -
Firm that allegedly took $93M in financing to buy thousands of pelvic mesh cases leads in TV advertising, report says
Oct 27, 2015 | South East Texas Record
By John O'Brien
...A lawsuit recently filed against the firm said it obtained $93 million in financing to purchase 14,000 pelvic mesh lawsuits... -
High post-pregnancy BMI raises pelvic organ prolapse risk
Oct 27, 2015 | Health Canal
By Karen N. Peart
Maintaining a normal body mass index (BMI) is important for good cardiovascular health and blood sugar control, but maintaining it after pregnancy can also be key to preventing pelvic organ prolapse... -
Maintaining normal BMI after pregnancy can help prevent pelvic organ prolapse
Oct 27, 2015 | News Medical
Maintaining a normal body mass index (BMI) is important for good cardiovascular health and blood sugar control, but maintaining it after pregnancy can also be key to preventing pelvic organ prolapse, according to a new study by Yale School of Medicine researchers. -
Rabiola Trial Rescheduled to 2016, First Trial for TVT-Secur
Oct 27, 2015 | Mesh Medical Device News Desk
By Jane Akre
The Josephine Marie Rabiola v. Ethicon trial, scheduled for Monday, October 26 in Austin, Texas has been rescheduled to February 2016 at the Austin court’s request.
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‘It was the worst mistake I ever made’
Oct 27, 2015 | Portsmouth News
After having four babies in five years, Dawn Martin, like many thousands of women, began to suffer stress incontinence as she got older.
It was acutely embarrassing to leak every time she coughed or sneezed and buying incontinence pads was humiliating.Dawn Martin
Desperate to sort the problem out she agreed to have a procedure called TVT – where a tape is attached underneath the bladder to strengthen it. A decision she says was ‘the worst mistake I have ever made’.
Dawn, a 53-year-old nurse practitioner, is one of thousands of women to have suffered complications following Tension-free Vaginal Tape.
Although many have the procedure and suffer no ill-effects afterwards, Scotland’s Chief Medical Officer recently wrote to health boards requesting they consider suspending routine use of synthetic mesh for these procedures until the outcome of an independent review is known.
In England, the Medicines and Healthcare Products Regulatory Agency still supports the procedure.It was like being cut with a cheese wire through my bladder and pubic areaDawn Martin
Dawn, of Park Avenue, Waterlooville, explains how her problems began: ‘In five years I had four big babies – my biggest was 10lbs.
‘I was in my 20s and even though I was a trained nurse but I didn’t listen to much about physiotherapy and pelvic floor exercises.
‘I wish I had because it supports your bladder and your back. You need to keep them strong.’
Dawn admits seeing TVT as a ‘quick fix’ and, although she put off having the operation for six months to see if pelvic floor exercises would help, her partner fell ill and she did not get round to doing them.
She says: ‘But I didn’t do any research. Frankly, it was the worst mistake of my life.’
The day surgery involves inserting a long piece of thin mesh vaginally to hold up the sides of the bladder to make it stronger.
But as soon as Dawn came round from the operation, in March last year, she knew something was wrong.
She says: ‘I was panic-stricken. ‘The pain was just unbearable. I had a total inability to pass urine. I had to rock back and forth on the toilet to get a tiny bit out.
‘I told the doctors but they said it was just down to inflammation and it would settle down.
‘But it didn’t. There is a two week window after the operation where the tape can be loosened but instead they offered me a scan to check for clots.’
Unfortunately the date for the scan was four weeks after the operation – too late for corrective surgery.
For the next four months Dawn had to self-catheterise to go to toilet.
It involves inserting a tube into her urethra which caused constant severe urinary tract infections.
‘I lived on antibiotics’ she says. ‘I have no issues with the urogynaecologists. Since it’s gone wrong they could not have done more for me.
‘The problem is they can put it (TVT) in but there’s so few people who can take it out.
‘My urogynaecologist did everything they could to help me.’
After persuading doctors that something had to be done, Dawn was offered a partial removal of the mesh. But when she was anaesthetised the anaesthetic reacted with the strong painkillers she was on and she went into respiratory arrest.
She says: ‘I woke up in ITU with nine people around the me and tubes absolutely everywhere. I was told there had been a big problem and they had not been able to do the surgery.
‘Despite everything that had happened, it was the worst thing they could have said to me. I was so desperate for the operation.’
It was eventually carried out in July this year and a small part was removed.
It gave Dawn temporary relief but excruciating pain soon returned.
She says: ‘It was like being cut with a cheese wire through my bladder and pubic area. My inner thighs were agony because my pudendal nerve was being irritated. Again, I had constant urinary tract infections.
‘I had spasms through my urethra and going to the toilet was toe-curlingly painful. It reduced me to an emotional wreck. Life as I knew it had been destroyed.’
To cope with the pain Dawn had anti-inflammatory injections in her pubic area and a pain relief and infection-fighting solution inserted directly into her bladder, weekly.
Eventually, doctors agreed that Dawn could have the TVT removed, which she did on October 1 at John Radcliffe Hospital, Oxford.
Although many surgeons are qualified to insert the tape only two in England can remove it.
She says: ‘It is not designed to come out. It’s a permanent fixture. Removing it is a big operation with lots of risks. It could cause long-term, permanent damage and I won’t know for 12 to 18 months if I will have normality back.
‘But when they finally agreed I felt sheer relief. I’ve been cured by default. The mesh was so tight I have thick scar tissue where it was and I’m not incontinent any more.
‘But, looking back, I would 100 per cent have rather been stress incontinent. I would have invested in Tena Lady and I would have gone to physio and worked much harder at my pelvic floor exercises.’ The campaign to ban the procedure - slingthemesh.wordpress.com.
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What is AkinMears hiding from Judge Joseph Goodwin?
Oct 27, 2015 | The West Virginia Record
As he presides over seven Multi District Litigation cases in Charleston involving more than 80,000 claims against manufacturers of transvaginal surgical mesh, U.S. District Judge Joseph Goodwin might want to keep a close eye on one plaintiffs firm in particular.
That would be the AkinMears firm of Houston, Texas.
A distinct reputation might not have preceded their foray into West Virginia, but the details of their alleged standard operating procedures, as revealed in a now-sealed lawsuit filed by a former salesman in Harris County District Court in Texas, are noteworthy.
Amir Shenaq, the firm's former chief business development officer, is seeking millions of dollars in compensation he was allegedly promised but denied. In his complaint, he describes AkinMears as not so much a traditional law firm as a “mass tort warehouse” and a “glorified claims processing center.”
In other words, Shenaq says AkinMears is the type of lawsuit mill that preys on victims and abuses our legal system in pursuit of a fast buck.
In the now-sealed suit, Shenaq alleges that AkinMears borrowed enormous amounts of money to spend on client recruitment efforts that included massive television advertising campaigns directed at mesothelioma victims and persons injured by medical products such as transvaginal mesh or certain prescription drugs. He claims AkinMears allegedly purchased existing mass tort suits from other firms, as well.
Rather than litigating or negotiating settlements, however, AkinMears often sells or resells the cases it has acquired, according to the suit.
AkinMears claims it sought to have Shenaq's petition sealed because it revealed valuable “trade secrets” and details of its “business model” that could prove useful to competitors. Its real concern may have been to keep the true nature of its business practices concealed from judges and juries hearing its cases.
Such information could prejudice someone on the bench or in the jury box who has high ethical standards and respect for our legal system.
Judge Goodwin might want to uncover what AkinMears does not want the public to know. -
Oct 27, 2015 | South East Texas Record
By John O'Brien
Trial lawyers will spend almost $900 million this year in broadcast advertising, a new report projects, with a firm that allegedly recently took in more than $90 million in funding to purchase lawsuits leading the way.
The report, written by University of San Francisco professor Ken Goldstein and Dhavan Shah of Sherpa Metrix, was prepared for the U.S. Chamber Institute for Legal Reform’s annual summit, held Tuesday.
Goldstein and Shah’s research showed that broadcast advertising has grown by 68 percent over the past eight years, from $531 million in 2008 to a projected $892 million in 2015.
“(L)egal advertising not only appears to be recession-proof, but also politics-proof,” the report says.
“Unlike other major sectors, such as automotive advertising, legal advertising is unaffected by the onslaught of rate-raising political ads that flood many markets in election years.”
Goldstein and Shah project that AkinMears of Houston will spend more than $25 million this year. They reached that figure by obtaining the amount the firm has already spent this year, as of Sept. 30, and prorating it to the end of the year.
A lawsuit recently filed against the firm said it obtained $93 million in financing to purchase 14,000 pelvic mesh lawsuits.
Following closely behind AkinMears in TV spending is Morgan & Morgan and the Houston firm Pulaski & Middleman.
The others in the top 10 in TV spending are Legalzoom.com; James Sokolove Law Firm; Goldwater Law Firm; Los Defensores Attorney; Avvo; Jim S. Adler; and Cellino & Barnes.
The Tampa, Fla., market has seen the most legal ads this year with more than 164,000. It is followed by Orlando, Fla.; Atlanta; Las Vegas; Milwaukee; Detroit, Louisville, Ky.; Birmingham, Ala.; Mobile, Ala.; and Houston.
The four categories seeing the most spending are prescription drugs ($57.3 million), medical devices ($45.7 million), asbestos ($45.6 million) and lawsuit funding ($39.6 million).
The report also studied trial lawyers’ efforts to promote their websites. Seventy-eight of the top 100 Google search terms were legal terms, according to WebpageFX and SemRush.
A firm that would want a higher place for its ad on the Google search “San Antonio car wreck attorney” would need to spend more money than any other legal search term, the report showed. -
High post-pregnancy BMI raises pelvic organ prolapse risk
Oct 27, 2015 | Health Canal
By Karen N. Peart
Maintaining a normal body mass index (BMI) is important for good cardiovascular health and blood sugar control, but maintaining it after pregnancy can also be key to preventing pelvic organ prolapse, according to a new study by Yale School of Medicine researchers.
The findings are published in the journal Reproductive Sciences.
Yale researcher Dr. Marsha K. Guess and her colleagues collaborated with first author Dr. Yi Chen, from Wenzhou Medical College in Zhejiang, China to analyze data from a prospective study of 108 women. They evaluated the role of BMI on pelvic organ prolapse from the women’s pregnancy through the first year after delivering their first baby. The team recorded the participants’ BMI and gave them a pelvic organ prolapse assessment.
“We found that an important risk factor for prolapse for women one year after delivery was their BMI, regardless of their baseline BMI at the first trimester, or how much they gained during pregnancy,” said Guess. “Specifically, the higher the BMI one year after delivery, the higher the risk for having pelvic floor laxity and increased offs for early stage pelvic organ prolapse,”
Pelvic organ prolapse is a common condition among women who have given birth vaginally, affecting up to 50% of women over age 40. Hormonal changes, increased pressure, and the baby’s passage through the birth canal can damage connective tissue, muscles, nerves, and blood vessels. The vagina and the surrounding organs relax, lose their support, and fall from their normal positions, leading to a host of complications such as urinary incontinence and poor bowel control. It is thought that some women are genetically predisposed to having an abnormal repair process after delivery, which may also contribute to pelvic organ prolapse.
Increasing BMI in non-pregnant women has been found to be a risk factor for developing prolapse, but the mechanism is unknown. This study suggests that maintaining a healthy weight after delivery is also important for good pelvic floor support.
Guess and her team found that on average, women in their study gain 1.9 kg (4.2 pounds) between baseline and one year postpartum
“Our findings show that even small differences in BMI one year after delivery can lead to pelvic floor laxity in normal-weight women,” said Guess. “These results shed light on a potential critical, time-dependent opportunity to modify the risk of developing pelvic organ prolapse for some women.
“Getting women into a routine of healthy diet and exercise habits, and back to their baseline weight after delivery may play an important role in preventing the early stages of prolapse,” she noted.
Other authors on the study include Benjamin Johnson, Fangyong Li, William C. King, and Dr. Kathleen Connell.
The study was funded in part by the Ministry of Health of Zhejiang Province.
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Maintaining normal BMI after pregnancy can help prevent pelvic organ prolapse
Oct 27, 2015 | News Medical
Maintaining a normal body mass index (BMI) is important for good cardiovascular health and blood sugar control, but maintaining it after pregnancy can also be key to preventing pelvic organ prolapse, according to a new study by Yale School of Medicine researchers.
The findings are published in the journal Reproductive Sciences.
Yale researcher Marsha K. Guess, M.D., and her colleagues collaborated with first author, Yi Chen, M.D., from Wenzhou Medical College in Zhejiang, China to analyze data from a prospective study of 108 women. They evaluated the role of BMI on pelvic organ prolapse from the women's pregnancy through the first year after delivering their first baby. The team recorded the participants' BMI and gave them a pelvic organ prolapse assessment.
"We found that an important risk factor for prolapse for women one year after delivery was their BMI, regardless of their baseline BMI at the first trimester, or how much they gained during pregnancy," said Guess. "Specifically, the higher the BMI one year after delivery, the higher the risk for having pelvic floor laxity and increased offs for early stage pelvic organ prolapse,"Related StoriesResearchers develop accurate method to predict postpartum diabetesNew study finds link between maternal protein deficiency during pregnancy and metabolic diseases in offspringPregnant women with elevated blood-sugar levels more likely to have babies with heart defects
Pelvic organ prolapse is a common condition among women who have given birth vaginally, affecting up to 50% of women over age 40. Hormonal changes, increased pressure, and the baby's passage through the birth canal can damage connective tissue, muscles, nerves, and blood vessels. The vagina and the surrounding organs relax, lose their support, and fall from their normal positions, leading to a host of complications such as urinary incontinence and poor bowel control. It is thought that some women are genetically predisposed to having an abnormal repair process after delivery, which may also contribute to pelvic organ prolapse.
Increasing BMI in non-pregnant women has been found to be a risk factor for developing prolapse, but the mechanism is unknown. This study suggests that maintaining a healthy weight after delivery is also important for good pelvic floor support.
Guess and her team found that on average, women in their study gain 1.9 kg (4.2 pounds) between baseline and one year postpartum
"Our findings show that even small differences in BMI one year after delivery can lead to pelvic floor laxity in normal-weight women," said Guess. "These results shed light on a potential critical, time-dependent opportunity to modify the risk of developing pelvic organ prolapse for some women.
"Getting women into a routine of healthy diet and exercise habits, and back to their baseline weight after delivery may play an important role in preventing the early stages of prolapse," she noted.
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Rabiola Trial Rescheduled to 2016, First Trial for TVT-Secur
Oct 27, 2015 | Mesh Medical Device News Desk
By Jane Akre
The Josephine Marie Rabiola v. Ethicon trial, scheduled for Monday, October 26 in Austin, Texas has been rescheduled to February 2016 at the Austin court’s request. The judge is not set in this rotating docket. The case is expected to be rescheduled one more time at a later date, perhaps mid-2016.
Rabiola is represented by the Matthews Law Firm as well as Freese and Goss.
The case was remanded from multidistrict litigation in Charleston, WV to Austin, Texas – Josephine Marie Rabiola v. Ethicon, 53rd Judicial District Court, Austin TX. Case no. D-1-GN-13-002039.
Ms Rabiola, of Austin, Texas, was 63 years old when she was implanted with two meshes – first theGynecare TVT Secur System to treat stress urinary incontinence (SUI) on May 24, 2010. She was then implanted with Gynecare Prosima Pelvic Floor System to treat pelvic organ prolapse (POP) on November 2, 2011.
TVT Secur tip, Neuman Urology, Israel
The meshes are made by Ethicon, a division of Johnson & Johnson and include polypropylene mesh tethered in place with two arms that extend up through the buttocks. They were approved through the FDA’s 510(k) approval process.
Both meshes were removed from the market in 2012. See the Mesh News Desk story here.
Even though they were voluntarily removed, a quick online search fines one can purchase the TVT-Secur for a suggested price of $900 here. (No date of this post is given.)
A legal victory was just handed to Ethicon this month in the Dallas trial of Cavness v. Ethicon. She was implanted with the Prosima mesh for pelvic floor repair.
Rabiola has included her implanting doctors in the action – Tomas G. Antonini M.D. of Lone Star Urogynecology and Continence Center, Seton Healthcare Family of Hospitals including its Medical Center, Johnson & Johnson and Ethicon.
THE COMPLAINT
The complaint says despite the claims polypropylene mesh is inert, scientific evidence shows the material is “biologically incompatible with human tissue and promotes an immune response.” In addition, it degrades, causing severe adverse reactions to the mesh including shrinkage from 30-50%, erosion and bacteria harbored in the small weave. Polypropylene is impure, the complaint says.
“There is no such thing as pure polypropylene. Polypropylene contains about 15 additional compounds which are leached from the polypropylene and are toxic to tissue which enhances the inflammatory reaction and the intensity of fibrosis.”
Mesh anchors are likely to pass through and injure major nerve routes in the pelvic region. Welding of the mesh during its production creates a toxic substance that contributes to the mesh degradation, says the complaint.
These mesh products were marketed to the public through aggressive campaigns despite the high failure and complication rates, according to attorneys for the Plaintiff who add that J&J and Ethicon have consistently under-reported and withheld information about the propensity of its products to fail and cause injury.
Injuries include mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, chronic pelvic pain, urinary and fecal incontinence and prolapse of organs. Many women must undergo repeat surgeries, pain control, injections, explant surgeries and repair surgeries in an attempt to rebuild what has been damaged.
She suffers physical pain and mental anguish, now and likely in the future; disfigurement; physical impairment and medical expenses, both now and in the future.
Ms. Rabiola was implanted on May 24, 2010 by Dr. Chris Hart with the TVT Secur to treat stress urinary incontinence. Dr. Antonini owns the medical group and he knew or should have known the pelvic mesh products had a high failure and injury rate, failed to perform as intended, and often required additional surgeries.
Ms. Rabiola went to Dr. Antonini to consult on the TVT Secur System and he recommended the Gynecare Prosima Pelvic Floor Repair System be implanted. He failed to inform her of all of the risks involved, according to her complaint. Had she known, she would not have consented to the implantations. On November 2, 2011, she had the products implanted to treat SUI and POP.
CAUSE OF ACTION
The causes of action include Negligence– J&J and Ethicon failed to use reasonable care in designing, manufacturing, marketing labeling and packaging its pelvic mesh products.
The doctor and hospital failed to select the proper treatment for SUI and POP patients and improperly selected her as a candidate for such products.
Other cause include Strict Liability, Design Defect – Dr. Hart and Antonini were in the business of supplying these products, which were defectively designed when they were sold and were unreasonably dangerous. The Plaintiff was not warned about the risks. This was proximate cause the damage and injuries to the Plaintiff.
Breach of Implied Warranty – The Plaintiff relied on the implied warranty of merchantability of the Defendant, which they breached because the products were not suited for their intended use.
Breach of Express Warranty – The Defendant made assurances to the public, to hospitals and doctors about the safety and fitness of their pelvic mesh products. Ms. Rabiola relied on those promises.
BACKGROUND ON TVT-SECUR
This will be the first trial of the TVT-Secur System, a mini-sling that mimics the TVT-Obturator placement. See European Urology here.
The only other trial of the TVT-Secur involved the case of Stacey Wilkins which was settled in a Joplin, Missouri State Court in May 2014 for an undisclosed amount. Adam Slater was her attorney. See the Mesh News Desk story here.
The TVT-Secur was intended to be the third generation and an improvement on TVT (transvaginal tape). In the case of a similar product, the Abbrevo mini-sling, Plaintiff Coleen Perry received a $5.7 million jury award in March 2015. #
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