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Ethicon 2/19
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Ga. Jury Hits J&J Unit With $4.4M Verdict Over Pelvic Implant
Feb 18, 2016 | Law360
By Emily Field
A Georgia federal jury on Thursday hit a Johnson & Johnson unit with a $4.4 million verdict, finding that a defective pelvic mesh implant caused a Florida woman’s recurring infections and incontinence in one of hundreds of cases targeting the company. -
Weighing the benefits and harms of transvaginal mesh
Feb 18, 2016 | The Clinical Advisor
By Lauren Biscaldi
A review of evidence highlighting the benefits and harms of using artificial mesh to repair vaginal prolapse has been published in the Cochrane Database of Systematic Reviews.
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Ga. Jury Hits J&J Unit With $4.4M Verdict Over Pelvic Implant
Feb 18, 2016 | Law360
By Emily Field
A Georgia federal jury on Thursday hit a Johnson & Johnson unit with a $4.4 million verdict, finding that a defective pelvic mesh implant caused a Florida woman’s recurring infections and incontinence in one of hundreds of cases targeting the company.
The jury found in favor of Florida resident Tessa Taylor, determining that a defective design in a prescription medical device known as the ObTape sling caused her injuries and that Mentor Worldwide LLC failed to adequately warn her or her doctor about the implant, according to the verdict form. The jury said that $4 million in punitive damages would serve to punish Mentor and "discourage others from behaving in a similar way."
The jury also awarded $400,000 to Taylor in compensatory damages.
The ObTape sling was implanted in women to treat stress urinary incontinence until the company discontinued it in 2006.
Taylor got the ObTape sling in 2004 to treat her incontinence, and for the next seven years she had bladder pain, back pain, bladder discomfort and problems with urinating, according to court documents. She was diagnosed with bladder inflammation and vaginitis several times and treated with antibiotics.
Her doctor then diagnosed her again with stress urinary incontinence and recommended that her ObTape be removed and replaced with another sling in 2011, according to court documents.
Taylor filed suit in 2012 as a tagalong to hundreds of complaints against Mentor consolidated in multidistrict litigation.
One day before the ObTape suits were consolidated, the company settled 111 of them at once last January, agreeing to establish a trust to manage and distribute funds agreed upon in 2014.
On Nov. 12, Mentor reached an undisclosed deal with Beryl Cole and Roger Gupton, whose complaint regarding the ObTape sling was among six designated as bellwethers by U.S. District Judge Clay D. Land in 2015 and was slated for a two-week jury trial starting Nov. 30.
Cole, who received the ObTape device in 2004, claimed in 2011 that she suffered infections, abscesses and scarring, requiring multiple surgeries.
Mentor had settled another proposed bellwether case in July 2013 shortly before trial.
Mentor scored a favorable verdict in June 2013 in a previous bellwether case when a jury found that plaintiff Irene Morey hadn't shown that the device maker was negligent.
Representatives for the parties didn’t immediately respond to requests for comment on Thursday.
Taylor is represented by Edward Blizzard, Katherine Cornell and Holly W. Gibson of Blizzard & Nabers LLP.
Mentor is represented by John Q. Lewis of Tucker Ellis LLP.
The case is Taylor v. Mentor Worldwide LLC, case number 4-12-cv-00176, in the U.S. District Court for the Middle District of Georgia.
The MDL is In Re: Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, case number 4:08-md-02004, in the same venue. -
Weighing the benefits and harms of transvaginal mesh
Feb 18, 2016 | The Clinical Advisor
By Lauren Biscaldi
A review of evidence highlighting the benefits and harms of using artificial mesh to repair vaginal prolapse has been published in the Cochrane Database of Systematic Reviews.
Led by Christopher Maher, MD, PhD, of the Royal Brisbane Women's Hospital in Queensland, Australia, a team of researchers conducted an analysis of 37 randomized controlled trials to determine the potential benefits and harms of using artificial mesh versus native tissue to repair vaginal prolapse; use of the mesh studied in these research papers has been disallowed since 2011.
“While transvaginal permanent mesh is associated with lower rates of awareness of prolapse, reoperation for prolapse, and prolapse on examination than native tissue repair, it is also associated with higher rates of reoperation for prolapse, stress urinary incontinence, or mesh exposure and higher rates of bladder injury at surgery and de novo stress urinary incontinence,” the researchers stated. “The risk-benefit profile means that transvaginal mesh has limited utility in primary surgery. While it is possible that in women with higher risk of recurrence the benefits may outweigh the risks, there is currently no evidence to support this position.”
The analysis, including low- to moderate-quality evidence gathered from 4,023 women, found that when permanent mesh was used, 10% to 15% of patients were aware of prolapse, compared with 19% of women who were aware of prolapse after undergoing native tissue repair. In addition, women who underwent permanent mesh repair had lower rates of repeat surgery, although 8% of these women did require repeat surgery for mesh exposure.
Additional low-quality evidence showed no difference in effectiveness of absorbable mesh when compared with native tissue repair, and no evidence existed to show a potential difference between biological graft and native tissue repair.
"This is a very significant review informing women about the surgical options available for the treatment of this debilitating condition," said Dr. Maher. "It summarizes the evidence of effectiveness of these approaches and their complications. It provides women with more information to make an informed choice about what treatment is best for them.”
According to the researchers, limited evidence suggests that absorbable mesh may reduce rates of recurrent prolapse on examination compared to native tissue repair. “But there was insufficient evidence on absorbable mesh for us to draw any conclusions for other outcomes,” they concluded. “There was also insufficient evidence for us to draw any conclusions regarding biological grafts compared to native tissue repair.”
In a corresponding editorial, Cindy Farquhar, MD, MPH, of the Department of Obstetrics and Gynecology at the University of Auckland in New Zealand, and Coordinating Editor of the Cochrane Gynecology and Fertility Group, commented, “This evidence underlines the need to balance the potential harms against the potential benefits of surgery. Future studies should report adverse events carefully and include reporting pain and quality of life.”
References
New health evidence gives women informed choice in the prolapsed surgery debate [news release]. London, England: Cochrane Library. Posted: February 9, 2016. Accessed February 17, 2016.
Maher C, Feiner B, Christmann-Schmid C, et al. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapsed. Cochrane Database Syst Rev. 2016;(2). doi: 10.1002/14651858.CD012079.
Farquhar C. No implementation without evaluation: the case of mesh in vaginal prolapsed surgery.Cochrane Database Syst Rev. 2016;(2). doi: 10.1002/14651858.ED000108
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