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Ethicon Media Monitoring 10/25/2017
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Court upholds $27m pelvic mesh verdict against Boston Scientific
Oct 24, 2017 | Mass Device
By Christopher Calnan
A federal appeals court last week upheld a plaintiff’s $27 million win over Boston Scientific (NYSE:BSX) in a product liability lawsuit brought over its Pinnacle pelvic mesh. -
Johnson & Johnson Facing Legal Fight Over Its Vaginal Mesh
Oct 24, 2017 | Healthline
By Heather Cruickshank
A trial is under way in a class action lawsuit over purported flaws in the company’s mesh products. Experts, however, say the implants are still beneficial. -
AM speaks out over pelvic mesh
Oct 24, 2017 | South Wales Argus
By Ian Craig
A NEWPORT AM has spoken out about the controversial pelvic mesh implant. -
Women have many treatment options for urinary incontinence
Oct 25, 2017 | Reuters (In Business Insider)
By Lisa Rapaport
Roughly half of adult women may experience urinary incontinence, but few of them get diagnosed and treated despite a wide range of options to address the problem, doctors say.
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Court upholds $27m pelvic mesh verdict against Boston Scientific
Oct 24, 2017 | Mass Device
By Christopher Calnan
A federal appeals court last week upheld a plaintiff’s $27 million win over Boston Scientific (NYSE:BSX) in a product liability lawsuit brought over its Pinnacle pelvic mesh.
A Florida jury in November 2014 found for Amal Eghnayem and three other plaintiffs who alleged that the Pinnacle mesh caused injuries including pain, bleeding and infection. Pelvic mesh implants are used to treat pelvic organ prolapse and female stress urinary incontinence.
The company was ordered to pay the women $26.7 million in compensatory damages, between $6.5 million and $6.7 million each. It will not face additional punitive damages.
Marlborough, Mass.-based Boston Scientific appealed to the U.S. Court of Appeals for the 11th Circuit, arguing that the Florida district court abused its discretion by lumping the four cases together, that Eghnayem failed to prove her design defect and failure to warn claims and that the statute of limitations had expired by the time she filed suit.
A three-judge panel for the 11th Circuit disagreed, finding that the original trial judge was correct to allow the jury verdict, and to deny Boston Scientific’s bid for judgment as a matter of law, according to court documents.
Boston Scientific reported revenue of $8.3 billion last year, up 12.2% compared with $7.4 billion the previous year.
http://www.massdevice.com/court-upholds-27m-pelvic-mesh-verdict-boston-scientific/
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Johnson & Johnson Facing Legal Fight Over Its Vaginal Mesh
Oct 24, 2017 | Healthline
By Heather Cruickshank
A trial is under way in a class action lawsuit over purported flaws in the company’s mesh products. Experts, however, say the implants are still beneficial.
Could vaginal mesh implants be putting some people at risk?
The Johnson & Johnson pharmaceutical company is facing a class action lawsuit in Australia over purported flaws in mesh implants used to treat stress urinary incontinence and pelvic organ prolapse.
More than 700 women are involved in the case.
Many of them claim the implants have caused debilitating pain and other complications.
The plaintiffs’ legal team has argued that Johnson & Johnson failed to rigorously test the devices and didn’t properly communicate the risks to surgeons and patients.
“[They were] overwhelmed by a tidal wave of aggressive promotion, designed to persuade both surgeons and patients of the quick, easy one operation able to resolve the particular difficulties,” senior counsel Tony Bannon told the court in his opening submissions.
Lawsuits related to urogynecologic mesh implants have also been filed against Johnson & Johnson and other manufacturers in the United States and the United Kingdom.
In one case, a woman in the United States was awarded $57 million for damages from a Johnson & Johnson mesh product.Common complications
Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are common complications of childbirth that affect many women.
SUI occurs when tissues that support the bladder and regulate the flow of urine weaken and allow urine to leak during activities such as laughing that put pressure on the bladder.
POP develops when weakened muscles and ligaments allow pelvic organs to drop from their normal position and press against the vaginal wall.
Severe cases of SUI or POP can be treated with surgery.
In some cases, urogynecologic mesh is used to reinforce weakened tissues and strengthen the surgical repairs.
“If you’re reattaching weak tissue to weak tissue, there’s a high chance that it could fail again,” Dr. Elizabeth Timbrook Brown, MPH, assistant professor of urology at MedStar Georgetown University Hospital in Washington, D.C., told Healthline.
“So that’s why mesh was created, to try to augment that repair to make it last longer,” she continued.
he majority of women who undergo surgical procedures with mesh don’t develop complications.
But some types of mesh implants have been associated with higher rates of adverse side effects than others.
“There are three different types of meshes,” Dr. Cheryl Iglesia, FACOG, section director of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center, told Healthline.
“There’s the mesh that’s used for prolapse, which can be divided into transvaginal and transabdominal mesh. And then there’s the mesh that’s used for stress urinary incontinence, which is usually just a small strap of mesh. Most of the complications occur with mesh used transvaginally for prolapse,” she said.
The most common complication associated with the use of transvaginal mesh is mesh erosion.
“The mesh can work its way out to the vaginal skin and in more severe cases erode into the underlying organs, like the bowel or the bladder. When it does that, it can lead to discharge, bleeding, pain, and the need for additional surgery,” Iglesia explained.
In 2011, the Food and Drug Administration (FDA) issued an update on the safety and efficacy of transvaginal mesh for POP.
It reported that serious complications from transvaginal mesh are “not rare.”
In comparison, lower rates of complications appear to be associated with transabdominal mesh.
The safety and effectiveness of full-length “multi-incision” mesh slings for SUI have also been well established, the FDA reported.
However, more research is needed on “mini-slings,” which might be less safe and effective than full-length alternatives.
One of the products named in lawsuits against Johnson & Johnson is a mini-sling, which was sold under the brand name of Gynecare TVT Secur between 2006 and 2012.Mesh implants can be helpful
According to leading urogynecologic associations, mesh implants still have a role to play in the treatment of SUI and POP.
In fact, the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) and American Urogynecologic Society (AUGS) consider full-length slings to be the “gold standard for stress incontinence surgery.”
The American Urological Association (AUA) has also issued statements on the use of mesh for SUI and POP.
While stating that certain people may benefit from repairs with mesh, the AUA emphasizes the importance of proper training for healthcare professionals and informed consent procedures.
People who are considering surgical repairs with or without mesh should speak with their doctors to learn about the potential benefits and risks of different procedures.
For example, the FDA provides a list of questions that patients should ask their providers before undergoing transvaginal repair of POP with mesh.
Those who have already undergone surgical repairs with mesh shouldn’t be concerned unless they’ve developed signs or symptoms of complications.
“If a patient has had mesh placed and is having symptoms — such as recurring urinary tract infections, pain during intercourse, pelvic pain in general, or some other notable complication — then certainly they should present to their physician to be evaluated,” Brown said.
“But if a patient has undergone a procedure and is completely asymptomatic, then they should not be concerned,” she added. “There’s nothing that says they should take the mesh out or have some sort of secondary procedure. And actually, the recommendation is currently against that if they have no symptoms.”
https://www.healthline.com/health-news/vaginal-mesh-lawsuits#6
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AM speaks out over pelvic mesh
Oct 24, 2017 | South Wales Argus
By Ian Craig
A NEWPORT AM has spoken out about the controversial pelvic mesh implant.
The pelvic mesh is a net-like implant used to treat stress incontinence, which is common in women after childbirth or during the menopause, and has been in use since the early 2000s.
But many women who have had the implant have reported pain or a failure to resolve the problem and have had to undergo surgery to have it removed. Hundreds of women across the UK are now suing the NHS.
Speaking in the Senedd on Tuesday, October 24, Newport West AM Jayne Bryant said: “I’ve been contacted by one of my constituents regarding her heart-breaking experience following her surgical pelvic mesh implants.
“My constituent has told me how the surgery impacted on her whole family and feels it’s destroyed her life at the age of 46 years old.
“She’s been unable to leave the house, unable to go to work, and is, consequently, on half pay, with severe concerns about what her future has to hold.
“This is one example of thousands of other women across the UK who face the same distressing issue.”
Leader of the house Jane Hutt agreed it was “an important issue” and said health secretary Vaughan Gething would be making a statement on the matter in the near future.
http://www.southwalesargus.co.uk/news/gwentnews/15616919.AM_speaks_out_over_pelvic_mesh/
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Women have many treatment options for urinary incontinence
Oct 25, 2017 | Reuters (In Business Insider)
By Lisa Rapaport
(Reuters Health) - Roughly half of adult women may experience urinary incontinence, but few of them get diagnosed and treated despite a wide range of options to address the problem, doctors say.
Women are particularly prone to stress urinary incontinence, when the pelvic floor muscles are too weak to support the bladder. As a result, urine leaks during coughing, sneezing or exercise. Childbirth is a common reason for weak pelvic muscles, and obesity worsens the problem.
Urge incontinence, in contrast, doesn’t have a clear cause, although it can sometimes happen due to neurological problems, the authors note.
Some women may get both types of incontinence at once or develop bladder problems due to a urinary tract infection.
Only about one in four women with urinary incontinence seek care, and then less than half of these patients receive treatment, doctors note in a review of available therapies published in JAMA online October 24.
“There are several barriers - the most important thing being women are embarrassed so they cope and don’t say anything,” said senior author of the review Dr. Linda Brubaker of the University of California San Diego.
“They should be honest with themselves – once these symptoms are interrupting their lives and they won’t go for a walk or run or they avoid intimacy because of this, they should seek care,” Brubaker said by email. “The earlier they connect (with a clinician) the easier the treatment is and the higher the chance of success.”
Urinary incontinence occurs twice as often in women as in men and is more common as women get older. If left untreated, it can interfere with daily activities and lead to decreased quality of life, researchers note.
“Urinary incontinence can occur for many different reasons, such as damage from childbirth or surgery, genetics or changes during aging,” said Dr. Blayne Welk, a researcher at Western University in London, Ontario, who wasn’t involved in the JAMA paper.
“Both types of incontinence can be treated with behavior changes and pelvic floor muscle therapy,” Welk said by email.
Behavioral approaches can include things like avoiding caffeine, drinking small amounts of fluid and using the bathroom at scheduled times throughout the day. Exercises can target the pelvic floor muscles and help improve bladder control.
For urge incontinence, women may also consider medication if the exercises and lifestyle changes don’t provide enough relief, the researchers note.
With stress incontinence, surgery to support the bladder with mesh slings can help stop urine leakage, but these procedures carry some risks and aren’t an option for all women. Devices inserted into the vagina or urethra also can help.
Botox injections may also be an option for some women.
“If a woman is bothered by symptoms of leakage, then she should know that there are effective treatment options and that it is worth talking to her doctor,” said Dr. Anne Suskind, a urology researcher at the University of California, San Francisco, who wasn’t involved in the paper.
There is almost always something that can be done to help with the leakage, and it is certainly worth starting this conversation,” Suskind said by email.
Because women may be embarrassed, doctors may need to start this discussion, she added.
“It is so important for physicians to ask patients about urinary incontinence, when appropriate, in order to open a dialogue and to help women who may benefit from treatment,” Suskind said.
SOURCE: http://bit.ly/2ldyhQk
http://uk.businessinsider.com/r-women-have-many-treatment-options-for-urinary-incontinence-2017-10
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