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ethicon 3/16
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Mullins Deadlines Set to Move Consolidated Pelvic Mesh Case To Trial
Mar 15, 2016 | Mesh Medical News Desk
By Jane Akre
It is the case that would consolidate 37 women, all implanted with Ethicon’s TVT (tranasvaginal tape) mesh into one trial. -
The incontinence surgery that's wrecked thousands of women's lives: Victim left wheelchair-bound from horrific internal lacerations reveals how she finally found a solution for embarrassing leaks
Mar 15, 2016 | Mail Online
By Kelly Strange
A mother who spent months in a wheelchair after suffering agonising side-effects from incontinence surgery is campaigning for the procedure to be banned. -
Australian prolapse mesh device manufacturer tells regulator it
Mar 15, 2016 | Newcastle Herald
By Joanne McCarthy
South Australian-based TFS Manufacturing modified its Tissue Fixation System device in 2009 and 2010 within five years of being registered on the Australian and American markets for use in surgery for women with prolapse, where pelvic muscles are weakened, usually after pregnancy. -
Complication Rates Low for Incontinence Sling Procedures
Mar 16, 2016 | Medscape
By Kate Johnson
When it comes to which surgical specialty is best suited to perform sling procedures, women with stress urinary incontinence can confidently go to either a gynecologist or a urologist, new research suggests. -
Case Filings Subside Across Most Federal Courts
Mar 16, 2016 | Law 360
By Andrew Strickler
...Much of that change, however, “resulted from a large increase in 2014 followed by a large decrease in 2015 in filings of cases in the Southern District of West Virginia related to pelvic repair products,” according to the report.
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Mullins Deadlines Set to Move Consolidated Pelvic Mesh Case To Trial
Mar 15, 2016 | Mesh Medical News Desk
By Jane Akre
It is the case that would consolidate 37 women, all implanted with Ethicon’s TVT (tranasvaginal tape) mesh into one trial.
It was schedule to be heard April 11, but now a new schedule issued by the judge presiding over this federal multidistrict litigation attempts to close any loopholes that have allowed the case to miss its trial date.
When it is heard later this year, it will be the largest number of plaintiffs to face Ethicon, a division of Johnson & Johnson, in one trial. There are more than 31,000 defective product cases filed before Judge Goodwin in this multidistrict litigation naming Ethicon, more than any of the other six plaintiffs.
Terreski Mullins and her 36 co-plaintiffs all reside in West Virginia, Even though they had different implanting physicians, they all received the TVT, a mesh used to treat incontinence. All claim injuries from the procedure and the mesh. In an effort to move these cases along, they were consolidated into one trial.
Judge Joseph Goodwin, in an order issued March 15th, says no case specific discovery has been conducted on the design defect claims, though discovery, expert disclosure and pretrial motions have been completed. The defense medical exams have also not been completed as there was disagreement on just what plaintiffs could request to make the exams more convenient and less intrusive.
Judge Goodwin in his order sets specific deadlines to move things along. Among them:
*March 31, 2016 – Plaintiff Face Sheet should be completed
*May 12, 2016- Interrogatories, Request for Admissions and documents should be completed. Both sides are limited to 15 interrogatories (a series of questions the other side poses of plaintiffs). Each side is limited to no more than six experts.
*May 26, 2016 – Plaintiffs serve expert reports on causation, warnings or case specific issues.
*June 16, 2016 ~ Defendants shall serve expert reports on causation, warnings and or case specific issues.
*June 27, 2016~ Rebuttal Expert Reports shall be served by plaintiffs on that date.
*July 25, 2016 ~ All discovery ends. (That is request of documentation from the other side). Motions in Limine are filed on this date, (what will be excluded from the trial).
While there is no date set for the Mullins trial of 37 plaintiffs, it could be assumed to be conducted sometime after August 8, 2016 when the response briefs to the Motions in Limine are due.
Plaintiffs immediately notified the court that they have set the depositions for the implanting physicians. They include:
May 18, 2016, the deposition of Courtney Pettiford, M.D. a doctor from Beckley, WV who implanted the TVT in Ms. Dameron (Case No. 2:13-cv-14799. The deposition of Dr. Joe Ellington will be conducted on May 20, another implanting physician from Princeton, WV. The deposition of Dr. Juddson Lindley, M.D. will be taken May 16th in Beckley, WV. Also in Beckley is Dr. Todd Resley who will be deposed May 24, 2016. (related to Ms. Cook’s implant. Case No. 2:13-cv-29260).
From Summersville, WV Dr. Lukasz Rostocki, M.D.’s deposition will be taken May 25. From Morgantown, WV, the deposition of Dr. Stanley Zaslau will be taken on May 26th. Dr. Cyrus Mali, M.D. of Charleston WV will be deposed by the plaintiffs on May 25, 2016 in relation to the case of Ms. Javins (Case No. 2:13-cv-29260).
Dr. Eddie Sze of Syracuse, NY, will also be deposed on May 3, in that city as well as April 29th by another plaintiff law firm. He was previously appointed to West Virginia university Hospital from 2005 to 2012. #
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Mar 15, 2016 | Mail Online
By Kelly Strange
A mother who spent months in a wheelchair after suffering agonising side-effects from incontinence surgery is campaigning for the procedure to be banned.
Like many women, Karen Griffiths, from Surrey, had suffered stress incontinence following childbirth.
The 51-year-old had a treatment called transvaginal tape (TVT) - a mesh implanted under the bladder like a hammock to treat incontinence by supporting the internal organs.
But the controversial procedure - which has already been blacklisted in Scotland - left her in agony.
TVT tape is now known to have a devastating design fault — a tendency to break up in the body, causing small fragments to cut their way into surrounding tissue.
This is described as the ‘cheesewire effect’, because of the excruciating pain it causes.
Mrs Griffiths is one of thousands of women suffering internal lacerations from the procedure that, in some cases, has left victims with difficulty walking.
They also suffer repeated pain and infection, worse incontinence and the end of their sex lives.
The damage she suffered was so debilitating it left her unable to walk or stand - and she also needed further surgery to partially remove the mesh.
‘It was agony and I can only compare the pain to being stabbed with a piece of glass,' she said.
'I could not walk and it was clear it had to come out. But at that point I thought I had just been very unlucky and my situation was a one off.’
Mrs Griffiths was horrified to later discover she is one of thousands of British women who, according to Department of Health figures, have been left suffering internal lacerations as a result of the procedure.
Victims have been left in misery, with pelvic problems that can cause difficulty walking, repeated pain and infection, worsened incontinence and, for some, the end of their sex lives.
Mrs Griffiths decided to have incontinence surgery when her condition suddenly worsened after years of being fairly stable.
The deterioration left her too embarrassed to take part in exercise classes and anxious in social situations, so when her GP offered her a surgical solution, she was happy to accept - and was initially pleased with the results.
However, six weeks after the operation she started suffering from painful complications including infections and internal lacerations from the implant.
The painful side-effects meant Mrs Griffiths was unable to walk and had to use a wheelchair.
Two months later, she underwent an operation to partially remove the mesh and repair the damage and spent months recovering.
She suffered infections, bloating and pain and was shocked to learn women around the globe were reporting similar horrifying side effects.
She has now joined forces with other women who claim the treatment has destroyed their health and are calling for it to be banned.
'It has been horrendous. I wish every day that I had not had it done but women are still being offered this procedure and are not fully aware of the consequences,' she said.
'I want to share my story to reach out to them so they can at least consider the implications. I wish I had been given that chance.
'I had no idea this surgery had caused so many problems for so many women.’
Since its introduction in 1996, the operation has quickly become the most popular NHS surgery for stress incontinence, and is performed on around 13,500 women a year.
Previously, patients may have been referred for operations to support the bladder neck, such as a Burch colposuspension, where the front wall of the vagina is lifted and stitched to a ligament behind the pubic bone.
This would have to be done by specialist surgeons whereas the mesh operation can be performed by surgeons with far less training.
It has been estimated that in one out of ten cases the mesh disintegrates and particles migrate and become embedded causing pain and infection.
Woman affected have compared their situation to those fitted with leaking breast implants and Mrs Griffiths said it was 'a ticking time bomb waiting to go off.'
She was inspired to speak about her bladder problems after Kate Winslet recently talked about stress incontinence following childbirth on television.
Mrs Griffiths, an administrator, has two daughters aged 23 and 21. The youngest was born after a two-hour labour which she thinks may have caused her bladder to prolapse.
She said she had suffered intermittent leaking ever since, but it did not became a major problem until five years ago.
'I noticed if I coughed or laughed I would leak a lot, often enough to require a change of clothes so naturally I became anxious in social situations,' she said.
It became so bad she was unable to do her usual exercise classes at the gym and she feared she would leave damp patches on chairs in meetings.
She wore a pad but feared spillage and the energetic routines meant it would become displaced.
'I would try and empty my bladder before to no avail. Then I’d do a star jump and that would be it. I would have to leave the class.’
Eventually she saw her GP who referred her for TVT surgery in May 2014.
'I didn’t ask many questions, I just trusted the advice I was being given by professionals that is was safe and that it would improve my situation.’
In July 2014 she had surgery to remove most of the mesh and reconstructive surgery to her injuries and scars.
It was weeks before she could walk again.
But despite the incontinence having improved she still suffered daily pain, bloating, swelling and aches.
‘I’m usually slim, but my stomach would look like I was eight months pregnant at time. I didn’t understand.
'I suffered depression and it put a huge strain on my relationship.’
After researching online, she found a support group for other women with similar experiences of TVT surgery.
She joined a campaign called Sling The Mesh which was started by fellow patient Kath Sansom who has also called for the use of the mesh to be suspended.
‘I was relieved to have women to talk to but shocked and distraught to think of the scale of the problem and that more women might unknowingly have a mesh fitted,' she said.
‘I decided I just wanted to warn as many women as possible.’
In November last year, Mrs Griffiths' leaking returned and she had to wear thick pads for protection.
She was recently introduced to a new brand of underwear called Diary Doll launched by TV presenter Carol Smilie and former tennis player Annabel Croft.
The knickers feature a hidden waterproof lining to avoid embarrassing leaks.
Whey they were originally designed for self-conscious teenagers to wear during their periods, they quickly became popular with older women suffering with stress incontinence.
Mrs Griffiths said they had boosted her confidence and offer an alternative to incontinence pads and the surgery.
'Incontinence pads are awful and women like myself just don’t want to wear them hence why I had the operation.
‘But these are fabulous and you can still feel feminine but have the confidence to know there will be no embarrassing incidents.
'Perhaps a product like this will help discourage women from having the operation because ultimately none of us should be in this situation.
'We will continue to campaign until the NHS takes notice.’
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Australian prolapse mesh device manufacturer tells regulator it
Mar 15, 2016 | Newcastle Herald
By Joanne McCarthy
AN Australian prolapse mesh manufacturing company, headed by a former Newcastle and Australian representative basketballer, substantially modified its device twice without advising regulators in Australia and the United States.
South Australian-based TFS Manufacturing modified its Tissue Fixation System device in 2009 and 2010 within five years of being registered on the Australian and American markets for use in surgery for women with prolapse, where pelvic muscles are weakened, usually after pregnancy.
TFS Manufacturing’s sole director, former Newcastle Falcons basketball player Paul Zadow, confirmed the modifications in a letter to the US Food and Drug Administration (FDA) in May, 2014, after the regulator deemed the modified TFS device “not approvable” following reviews of more than 60 prolapse mesh devices on the market.
“We modified the product several times in 2009 and 2010. We did not believe that any of the changes required a new (application), so we documented the changes in our files,” Mr Zadow wrote.
In 2014 a patient advocate asked Australia’s medical device regulator, the Therapeutic Goods Administration (TGA), to investigate the modified device because changes to the mesh, and anchors used to secure the mesh to women’s ligaments and tissue, meant it was substantially different to the originally approved device.
The TFS device and more than 40 other mesh devices were registered in Australia based on being the “same kind” of device as mesh devices for incontinence surgery.
They were approved despite no evidence of use in prolapse surgery, and warnings of the need for clinical trials for incontinence mesh that had already been registered.
Mr Zadow did not respond to questions about the modifications, but in a statement last week he said the company withdrew its mesh device from the American market for commercial reasons. The TFS device was deregistered in Australia in November 2014. The company’s appeal against that decision is ongoing.
In January the FDA reclassified all prolapse mesh products as high risk.
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Complication Rates Low for Incontinence Sling Procedures
Mar 16, 2016 | Medscape
By Kate Johnson
When it comes to which surgical specialty is best suited to perform sling procedures, women with stress urinary incontinence can confidently go to either a gynecologist or a urologist, new research suggests.
Despite the number of litigations related to sling procedures, the overall complication rate is very low, said lead investigator Björn Löppenberg, MD, from the Department of Urologic Surgery and the Center for Surgery and Public Health at Brigham and Women's Hospital in Boston.
"However, we were able to identify certain patients who are at risk for complications" who should be observed more intensely, regardless of which surgical specialty is treating them, he reported here at the European Association of Urology 2016 Congress.
Dr Löppenberg and his colleagues assessed 10,508 sling procedures in the American College of Surgeons National Surgical Quality Improvement Program database that were performed to treat female stress urinary incontinence from 2005 to 2013.
Urologists performed 43.2% of the procedures and gynecologists performed 56.8%.
Comparing Urologists and Gynecologists
Urology patients were significantly older than gynecology patients (P < .05), had higher comorbidity rates (P < .05), and had more American Society of Anesthesiologists (ASA) scores of at least 3 (P < .05). Gynecologists performed significantly more additional procedures than urologists (22.2% vs 10.5%, P < .0001).
Patients at risk for complications were older, more obese, had an ASA score of at least 3 (odds ratio [OR], 1.6; P = .001), and had a prolonged operative time (OR, 1.9; P < .0001). "These factors have to be taken into account when counseling patients for a sling procedure," said Dr Löppenberg.
There were no differences in cardiovascular, pulmonary, thrombotic, septic, renal, wound, or bleeding complications 30 days after surgery between the two specialties.
However, there were significantly more urinary tract infections, which made up 84.3% of all 30-day complications, in gynecology patients than in urology patients (3.6% vs 2.3%; OR, 1.55; P < .0001).
Complication Rate of 3.5%
The overall complication rate 30 days after the procedure was 3.5%. That rate was slightly higher in gynecology patients than in urology patients (4.1% vs 2.9%; OR, 1.42; P =.001).
The reason for this is unclear. "It may be a difference in specialty training; however, this database only gives general specialty, so we were not able to assess subspecialty," Dr Löppenberg explained. "In any case, the difference is very small."
It is not surprising that urologists had lower complication rates, despite having older patients with more comorbidities, said Joceline Liu, MD, from the Department of Urology at Northwestern University in Evanston, Illinois.
"This clinically makes sense, as urologists are often treating potentially more complex cases of stress urinary incontinence that are associated with other urologic conditions, while gynecologists may more commonly treat uncomplicated cases in patients without prior urethral surgeries," she told Medscape Medical News.
"That being said, the definition of 'complication' in most cases was urinary tract infection, which, while interesting, may be less clinically significant. It is difficult to properly match these two patient populations, as there is inherent bias in referral patterns and differences in comorbid conditions between specialties," Dr Liu said.
"It would be interesting to further analyze the data for outcomes and complication rates for sling among subspecialty-trained physicians," such as urogynecologists and female pelvic medicine and reconstructive surgeons, she added.
Dr Löppenberg and Dr Liu have disclosed no relevant financial relationships.
European Association of Urology (EAU) 2016 Congress: Abstract 7. Presented March 12, 2016.
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Case Filings Subside Across Most Federal Courts
Mar 16, 2016 | Law 360
By Andrew Strickler
The flow of case filings last year slowed across most branches of the federal judiciary, according to a report on Tuesday, with another double-digit drop in U.S. bankruptcy court petitions.
The annual report from the director of the Administrative Office of the U.S. Courts found total filings in the U.S. courts of appeals down 4 percent in 2015 to 52,698. The number of U.S. district court filings also fell 5 percent to 359,105. Civil case filings declined 6 percent to 279,036.
Petitions filed in U.S. bankruptcy courts dropped 11 percent to 860,182, a second year in a row decline of more than 10 percent.
Last year’s bankruptcy petition volume was the lowest since 2007, according to the Judicial Business 2015 report, the first full year of the tally following the enactment of the Bankruptcy Abuse Prevention and Consumer Protection Act of 2005.
Consumer petitions, which accounted for approximately 97 percent of all petitions, dropped 11 percent to 835,197, according to the report. Business petitions fell 12 percent to 24,985. Last year’s report found consumer and business bankruptcy court petitions at 963,739, down 13 percent from 2013.
In the district courts, civil filings per authorized judgeship dropped from 436 in 2014 to 412 in 2015.
New district court filings in disputes between citizens of different states were down 14 percent to 86,358, with personal injury and product liability cases dropping one-third to 39,309.
Much of that change, however, “resulted from a large increase in 2014 followed by a large decrease in 2015 in filings of cases in the Southern District of West Virginia related to pelvic repair products,” according to the report. “When these cases in this district are excluded from the totals, national filings of diversity of citizenship cases remained stable, rising 1 percent.”
Filings with the United States as defendant decreased 7 percent to 35,659, largely because of a sharp decline in prisoner petition cases, according to the report. An overall drop of 10 percent in filings with the United States as plaintiff was attributed to a 22 percent decline in forfeiture and penalty cases and a more modest drop in cases involving contracts.
Civil case terminations increased 6 percent to 274,627, with the biggest growth happening in the Southern District of West Virginia. That court terminated a total of 12,594 cases, more than 9,300 of them product liability multidistrict litigation cases alleging injuries from pelvic repair products.
The number of civil and criminal trials completed in the district courts by active and senior Article III judges was down 5 percent to 11,568. The number of civil trials was essentially flat from 2013 at 4,734, according to the report.
The median time from filing to disposition for civil cases was 8.8 months, up from 8.3 months in 2014.
A statistical analysis that takes into account the time it takes judges to resolve various civil and criminal actions found weighted civil filings dropping in 42 districts and increasing in 49 districts. The District of Kansas, the Eastern District of Texas and the Eastern District of Louisiana each had a jump of more than 100 weighted civil filings per judgeship.
In the U.S. courts of appeals, 76 percent of all filings arose from cases originating in district courts. The overall filings reductions came from smaller volumes in in civil appeals, including prisoner petitions and other private civil cases, and filings of original proceedings and miscellaneous applications.
Filings of criminal appeals, U.S. civil appeals other than prisoner petitions, bankruptcy appeals and administrative agency appeals were up.
The annual report includes statistics from all federal courts, the federal probation and pretrial services system, and covers the 12-month period ending Sept. 30, 2015.
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