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Ethicon 7/2
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Judge tweaks consolidated trial plan for Ethicon mesh suits
Jul 2, 2015 | Reuters
By Jessica Dye
A federal judge in West Virginia overseeing thousands of lawsuits over transvaginal mesh on Wednesday revised his plan for a single consolidated trial over whether Johnson & Johnson subsidiary Ethicon Inc's devices were defectively designed, pushing back the start date by a month and adding new plaintiffs to the roster -
Georgia AG Wades Into Mesh Implant Appeal In 4th Circ.
Jul 2, 2015 | Law360
By Jody Godoy
The Georgia Attorney General weighed in on C.R. Bard's appeal in the Fourth Circuit over a $2 million jury verdict for a vaginal mesh plaintiff on Thursday, defending a law that sent three quarters of the punitive damages to the state. -
Women have reported “serious and debilitating problems” following an operation for incontinence often caused by childbirth
Jul 2, 2015 | Wisbech Standard
By Kath Sansom
A report into the safety of an operation to cure women’s incontinence, carried out regularly in hospitals in Cambridgeshire, has used evidence that is “high risk” for bias. -
Midurethral Sling Helpful for Stress Urinary Incontinence
Jul 2, 2015 | Medscape
By Laurie Barclay MD
Midurethral sling operations for stress urinary incontinence in women have a good safety profile and are highly effective in the short and medium term, based on a systematic reviewpublished online July 1 in the Cochrane Database of Systematic Reviews. -
New study helps women with stress incontinence make informed treatment choices
Jul 2, 2015 | Health 24
A new Cochrane systematic review on surgery for stress urinary incontinence makes an important contribution to an ongoing debate and will help women to make more informed choices about treatment.
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Judge tweaks consolidated trial plan for Ethicon mesh suits
Jul 2, 2015 | Reuters
By Jessica Dye
A federal judge in West Virginia overseeing thousands of lawsuits over transvaginal mesh on Wednesday revised his plan for a single consolidated trial over whether Johnson & Johnson subsidiary Ethicon Inc's devices were defectively designed, pushing back the start date by a month and adding new plaintiffs to the roster.
Earlier this month, U.S. District Judge Joseph Goodwin had said that claims from 26 women suing over Ethicon's TVT device would be addressed in a single trial to start in November. But after it emerged that some of the women had been implanted with multiple mesh devices, he tweaked the plaintiff list, which now includes 39 women, and moved back the trial to December 7.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/1KuHj0l
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Georgia AG Wades Into Mesh Implant Appeal In 4th Circ.
Jul 2, 2015 | Law360
By Jody Godoy
The Georgia Attorney General weighed in on C.R. Bard's appeal in the Fourth Circuit over a $2 million jury verdict for a vaginal mesh plaintiff on Thursday, defending a law that sent three quarters of the punitive damages to the state.
In an intervenor brief, Georgia state attorney Samuel Olens laced into plaintiff Donna Cissons' cross-claim in the appeal that a West Virginia District Court had erred in finding no constitutional problems with Georgia's punitive damages statute. The state attorney general said Cisson's argument relied on a federal ruling from 1990, before Georgia's supreme court ruled three times that the law handing 75% of a punitive damages take to the state in product liability actions is constitutionally sound.
“Courts across the nation have evaluated punitive damage schemes similar to Georgia’s and agreed that there are no violations of the United States Constitution,” Olens said. “The only authority in which plaintiffs find support is an outdated federal district court case that has been broadly and uniformly criticized.”
A West Virginia federal jury awarded $1.75 million in punitive damages and $250,000 in compensatory damages to Donna Cisson in August 2013. Bard appealed in January.
In her opposition to the appeal, Cisson told the Fourth Circuit that Bard’s argument that the court wrongly excluded evidence relating to an FDA rule requiring device makers to notify the agency 90 days before marketing a medical device rests on a faulty premise. She also asked the appeals panel to find unconstitutional a Georgia state law that requires prevailing product liability plaintiffs to pay 75 percent of her punitive damages to the state.
Cission argued that the state law allowing punitive damages created a property right to punitive damages awards.
Olens countered in the intervenor brief that Cission hadn't supported her assertion. The Attorney General pointed to Ninth Circuit and other rulings that had examined a similar laws and found that, unlike compensatory damages, punitive damages cannot be considered property because there is no inherent right to collect them. The law therefore does not violate the takings clause of the constitution, Olens argued.
Olens also argued that the law does not violate the equal protection clause, because unlike other torts, product liability actions by nature deal with harms not only to the individual but to the public at large, and that punitive damages are primarily meant to punish the offender, not garner a windfall for the plaintiff.
The Georgia attorney general touched briefly on the state's interest in the outcome of the appeal on its merits, saying that “to overturn the jury's verdict in this matter would directly contravene the State of Georgia's strong public interest in protecting its citizens from dangerous products, and from the sort of egregious misconduct that the jury found to exist in this case.”
Counsel for the parties did not reply to requests to comment on Thursday.
Georgia Attorney General Samuel S. Olens is represented by himself, W. Wright Banks Jr. and Julie Adams Jacobs of the Attorney General's office.
Cisson is represented by Anthony J. Majestro of Powell & Majestro PLLC, Allison Van Laningham Mullins of Turning Point Litigation and Henry G. Garrard III and Josh B. Wages of Blasingame Burch Garrard & Ashley PC.
Bard is represented by Lori G. Cohen, Brigid F. Cech Samole, Elliot H. Scherker Jay, Andrew Yagoda and Sean Jessee of Greenberg Traurig LLP.
The case is Cisson v. C. R. Bard Inc., case number 15-1102 in the U.S. Court of Appeals for the Fourth Circuit. -
Jul 2, 2015 | Wisbech Standard
By Kath Sansom
A report into the safety of an operation to cure women’s incontinence, carried out regularly in hospitals in Cambridgeshire, has used evidence that is “high risk” for bias.
A piece of polypropylene TVT mesh showing tiny blue particles that can break off before or during insertion for an oepration to cure incontinence
The Cochrane Report, published this week, says the TVT mesh sling is successful in eight out of ten cases, but the authors have used 13 trials that they admit are at high risk of bias.
An independent panel studied 81 trials but only two pieces of evidence were considered to have a “low risk” of bias.
A further 56 are “unclear” about whether they are objective, by, for example, the authors having links to mesh manufacturers.
Cambs Times reporter Kath Sansom launched awareness campaign Sling The Mesh after suffering since having the operation four months ago.Kath Sansom has launched a campaign against a gynaecology operation in which a TVT sling is used.
Around 40% of women have the problem after natural childbirth which weakens pelvic floor muscles.
Kath said: “Most of the trials carried out since the sling was introduced 18 years ago focus on if it has cured the incontinence or they compare two different styles of operation - the TVT or the TVTO.
“There are no robust trials over a long time that show the potential painful complications that women can suffer.
“The operation may be a success by curing incontinence, but for some women it can be a massive fail by dramatically reducing quality of life.
“Until there is more unbiased research or a National Register where it is mandatory for surgeons to report complications, there will be no clear picture of the risks or how long it takes for them to cut in. For some it can be years later.”
Within a month of launching Sling The Mesh more than 600 people have joined Kath’s Facebook support group with problems of leg pain, hip pain, groin pain, difficulty going to the toilet or unable to have sex again due to mesh cutting into vaginal walls.
Some are in wheelchairs or struggle to walk far due to nerve damage or the mesh pressing on nerves.
Joseph Ogah, consultant gynaecologist, who the report says ‘is sponsored to attend workshops by Johnson and Johnson’, said: “We need to know more about what happens to women in the long term. This review found 35 trials carried out more than five years ago.
“If all the women in these trials were followed up we would know much more about how long the operations last and, crucially, whether they had developed late but important side effects.”
Cochrane Report lead author, Abigail Ford, from Bradford Teaching Hospitals said: “This is a very significant review informing women about the minimally invasive surgical options available for the treatment of this very debilitating condition.
“It helps to clarify the pre-existing evidence on the effectiveness of these approaches and their side effects in the short term, as well as introducing longer term evidence of efficacy and safety. It helps to give women more information to make an informed choice.
“As all surgery carries some risk women must weigh up carefully how much they are troubled against taking a small chance that things may go wrong.”
The report says problems have led to “many court actions worldwide, with cases already under way in the UK, USA and Canada.”
Co ordinating editor of the Cochrane Report, Cathryn Glazener, who is involved in overseeing the first human trials of mesh slings, said: “Safety concerns about slings have made international headlines in recent months. Independent reviews of the evidence for efficacy, effectiveness and safety have already been conducted or commissioned in Australia, Denmark, the European Commission, France, the Netherlands, New Zealand, the UK, and the USA.”
She added: “Women have reported serious and debilitating problems following surgical treatment for stress urinary incontinence…using vaginal mesh implants.
“The number of reports to MHRA is low compared to the overall use of these implants, there is some evidence of under-reporting and there are concerns that MHRA is not aware of all women who have experienced problems.”
But despite that the MHRA insist the risks outweigh the benefits.
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Midurethral Sling Helpful for Stress Urinary Incontinence
Jul 2, 2015 | Medscape
By Laurie Barclay MD
Midurethral sling operations for stress urinary incontinence in women have a good safety profile and are highly effective in the short and medium term, based on a systematic reviewpublished online July 1 in the Cochrane Database of Systematic Reviews.
However, the sling implant is made of an artificial, nonabsorbable plastic mesh tape, which may explain reports of postoperative pain and injury. Although evidence is also building for long-term efficacy, differences in complications and the long-term need for repeat surgery should be weighed when considering sling surgery.
An additional consideration is use of the retropubic route, in which the tape passes behind the pubic bone and exits via the abdomen, or the transobturator route, in which the tape passes side-to-side and exits via the groin.
"This is a very significant review informing women about the minimally invasive surgical options available for the treatment of this very debilitating condition," lead author Abigail A. Ford, MD, from the Bradford Royal Infirmary, United Kingdom, said in a news release. "It helps to give women more information to make an informed choice."
However, Dr Ford cautions women to try less invasive alternatives such as pelvic floor (Kegel) exercises before contemplating any type of surgery. "As all surgery carries some risk, women must weigh up carefully how much they are troubled by their urine leakage against taking a small chance that things may go wrong as a result of surgery," she said.
Risk for bladder damage during surgery was lower with transobturator insertion (0.6% vs 4.5% in the retropubic group), as were rates of major vascular or visceral injury, mean operating time, operative blood loss, and length of hospital stay. The transobturator group also fared better in terms of postoperative voiding dysfunction (4% vs 7% in the retropubic group).
The downside of the transobturator procedure was greater likelihood of groin pain in the short term (6.4% vs 1.3%), as well as some low-quality evidence from four trials suggesting an increased need for repeat surgery compared with retropubic insertion.
For transobturator techniques, there was no evidence favoring the use of a medial-to-lateral vs a lateral-to-medial insertion, but for retropubic tapes, a bottom-to-top route was more effective than a top-to-bottom route.
At 1- to 5-year follow-up, the overall rate of erosion of the tape into the vagina was about 2% after either type of surgery, and both groups also had low rates of pain during sexual intercourse.
Of 81 trials included in the systematic review, enrolling a total of 12,113 women, 55 trials (8652 participants) directly compared retropubic and transobturator slings. There was moderate-quality evidence that either route effectively resolved symptoms in approximately 80% of women at around 12 months.
However, few studies reported 5-year data, and among these, subjective cure rates in either group were approximately 70%, ranging from 43% to 92% in the transobturator group, and from 51% to 88% in the retropubic group.
"We need to know more about what happens to women in the long term," senior author Joseph Ogah, MBBS, MRCOG, from University Hospitals of Morecambe Bay National Health Service Foundation Trust, Cumbria, United Kingdom, said in the news release. "Rather than starting any new trials in this area we need to obtain long-term follow up from the existing trials.
"Although this review compares the two most common operations in current practice in the developed world, we need more robust evidence about how well they compare with the older types of surgery that they have superseded."
The investigators identified randomized or quasirandomized controlled trials in which both trial groups involved a midurethral sling operation by searching the Cochrane Incontinence Group Specialised Register. Two review authors independently examined the methodological quality of potentially eligible studies and extracted data from the included trials.
The National Institute for Health Research funded this review. Dr Ford received funding from Johnson & Johnson for part sponsorship to attend the 2014 International Urogynaecology Association conference. One coauthor received funding from Astellas for attendance at the European Urogynaecological Association meeting in Berlin. Dr Ogah received funding for conference registration fees and speaker honoraria by Astellas UK and was sponsored to attend workshops by Johnson & Johnson and Speciality European Pharma. The remaining coauthor has disclosed no relevant financial relationships
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New study helps women with stress incontinence make informed treatment choices
Jul 2, 2015 | Health 24
A new Cochrane systematic review on surgery for stress urinary incontinence makes an important contribution to an ongoing debate and will help women to make more informed choices about treatment.
Inserting a ‘mid-urethral sling’, a type of tape, to support the muscles of the bladder by either the groin or abdomen results in similar cure rates. However, differences in complications and the long term need for repeat surgery mean that women will need to balance a number of different factors when choosing an operation.
What is stress urinary incontinence?
Stress urinary incontinence (SUI) is the involuntary loss of urine that occurs withcoughing, sneezing or physical exertion. It is a common problem, particularly in women who have had children, and affects millions of people worldwide. It happens due to weaknesses in the structures supporting the bladder and bladder outlet (urethra), mainly the pelvic floor muscles, which then fail to stop urine leaking out when the bladder is under stress, such as when laughing or sneezing, or because of a weakness in the sphincter muscle which normally holds the urethra closed.
Women whose symptoms persist despite trying non-surgical approaches such as pelvic floor exercises may be suitable for surgery in order to improve bladder control. Surgery uses one of two common operations to insert a sling under the urethra in an effort to keep it supported. One approach is the insertion of a sling behind the pubic bone coming out via the abdomen (the bottom-to-top 'retropubic' route), or alternatively from side-to-side coming out through the groin (the 'transobturator' route).
Transobturator insertion carries lower risk of bladder damage
The team of researchers included information from 81 trials in total, of which 55 made the direct comparison between the retropubic and transobturator routes. They found moderate quality evidence that at around 12 months, both routes had successfully cured symptoms in 80% of women. From the few studies that had reported 5 year data, rates of cure in both groups had fallen to around 70%.
Transobturator insertion seemed to carry a lower risk of bladder damage during the operation with around 6 women in 1000 experiencing this compared with 50 in 1000 in the retropubic groups, and fewer women (40 in 1000) in the transobturator group had persistent difficulty in being able to empty their bladder completely compared with around 70 in 1000 in the retropubic group.
In contrast, the transobturator operation led to more short-term groin pain and there is some limited evidence that women who undergo transobturator route insertion are more likely to need a repeat operation later on than women who had a retropubic insertion. The overall rate of erosion of the tape into the vagina was 2% following either surgery when the studies had completed follow-up at between 1 and 5 years. The rate of pain during sexual intercourse was also low in both groups.
Read: Yoga helps women with urinary incontinence
Safety of continence surgery has been questioned
Over the last few years many questions have been raised about the safety of continence surgery because it involves implanting a sling made of an artificial mesh. There have been a number of reports of women suffering pain and injury after surgery, thought to be due to the sling which is made of non-absorbable plastic. This has led to many court actions worldwide, with cases already under way in the UK, the USA and Canada. In Scotland, the Health minister called for hospitals to consider the suspension of mesh operations until more evidence is available. An independent review set up in Scotland in 2014 to review the safety of these operations will publish its findings later this year. This latest Cochrane Review is one of a number of sources of evidence which will inform the findings of that independent review.
Read: The dangers of transvaginal mesh to repair urinary incontinence
Lead Author, Abigail Ford from the Bradford Teaching Hospitals says, “This is a very significant review informing women about the minimally invasive surgical options available for the treatment of this very debilitating condition. It helps to clarify the pre-existing evidence on the effectiveness of these approaches and their side effects in the short term, as well as introducing longer term evidence of efficacy and safety. It helps to give women more information to make an informed choice.”
Dr Ford continues, “Understanding this evidence in context is really important for women. They need to be aware of less invasive alternatives such as pelvic floor exercises which should be tried first before contemplating any type of surgery. As all surgery carries some risk women must weigh up carefully how much they are troubled by their urine leakage against taking a small chance that things may go wrong as a result of surgery.”
Joseph Ogah, Consultant Gynaecologist says, “We need to know more about what happens to women in the long term. This review found 35 trials carried out more than five years ago: if all the women in these trials were followed up we would know much more about how long the operations last and, crucially, whether they had developed late but important side effects. Rather than starting any new trials in this area we need to obtain long-term follow up from the existing trials."
Mr Ogah also says, “Although this review compares the two most common operations in current practice in the developed world, we need more robust evidence about how well they compare with the older types of surgery that they have superseded: it may be helpful to look at indirect comparisons if direct evidence is not available or reliable enough.”
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