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Ethicon Media Monitoring 6/15/17
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Mesh implants. A “simple” fix that is destroying surgical skills and women’s lives
Jun 14, 2017 | Wisbech Standard
By Kath Sansom
The worry comes amid a growing tide of concern that the implants have been aggressively marketed in the last 20 years which has left new surgeons not getting enough experience of alternative operations. -
J&J To Pay $20 Million In Pelvic Mesh Trial
Jun 15, 2017 | Lawyers.com Blog
By Debra A. Jensen
Johnson & Johnson (J & J) has been ordered to pay a woman $20 million as a result of defective vaginal-mesh inserts that caused serious damages. This is the first verdict against Johnson & Johnson in the last year; two others are going to trial in upcoming months and there are more than 54,000 more that are pending across the country.
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Mesh implants. A “simple” fix that is destroying surgical skills and women’s lives
Jun 14, 2017 | Wisbech Standard
By Kath Sansom
The worry comes amid a growing tide of concern that the implants have been aggressively marketed in the last 20 years which has left new surgeons not getting enough experience of alternative operations.
In the UK this month a study carried out in three centres - Leicester, Newcastle and Galway in Ireland - said many surgeons choose mesh as they don’t have the skills to do traditional alternatives.
In Germany surgeons Dimitri Barski and Thomas Otto said of the pelvic floor implants: “The future of surgical care depends on the research we do now.
“If we don`t address the current shortfalls catastrophic problems like falsified research, bad quality implants and surgical techniques will destroy patients faith.”
Meanwhile, in America, surgeon Himanshu Aggarwal is among a team of surgeons who this month published a book on how to carry out three alternative fixes for incontinence - Burch, slings made from a patient’s own tissue or vaginal wall suspension pioneered by Dr Philippe Zimmern.
Mr Aggarwal said: “The main reason to write the book was to disseminate the information and techniques to make the medical community aware that there are effective techniques available and we don’t need mesh.”
The synthetic implants have been used in women in hospitals globally for nearly two decades.
In the last ten years more than 92,000 mesh tapes have been implanted into women in the UK to fix incontinence.
A new survey suggests that as time goes by, the skills to carry out mesh-free traditional surgery fixes are being lost.
Some surgeons don’t choose mesh implants as a preference , it said, but because they are: “Unable to offer alternative procedures because they had not received training in procedures such as colposuspension or fascial sling.
“Patients hope and expect that doctors know what they are talking about and that treatments offered are the most suitable/effective,” the report said.
“However, it is clear that the treatments may depend largely upon the discipline and training of the surgeon,” rather than any evidence.
“This is an important finding not only for future research plans, but also as a training and clinical governance issue, bearing in mind the increasing concerns about mid urethral tape (MUT) complications, how they are managed, and the possibility of providing women with alternative choices.”
The inconsistency of surgeon responses will generate “considerable concern”among patients, the report adds.
http://www.wisbechstandard.co.uk/news/mesh-implants-a-simple-fix-that-is-destroying-surgical-skills-and-women-s-lives-1-5062225
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J&J To Pay $20 Million In Pelvic Mesh Trial
Jun 15, 2017 | Lawyers.com Blog
By Debra A. Jensen
Philadelphia Product Liability Lawyers: Johnson & Johnson to Pay $20 Million in Pelvic Mesh Trial
Johnson & Johnson (J & J) has been ordered to pay a woman $20 million as a result of defective vaginal-mesh inserts that caused serious damages. This is the first verdict against Johnson & Johnson in the last year; two others are going to trial in upcoming months and there are more than 54,000 more that are pending across the country.
A Philadelphia jury decided that J & J’s TVT-Secur mesh was defectively designed. The plaintiff said that the mesh broke down after being implanted in her body, and she had to have several surgeries in order to fully remove it. She also said that the mesh caused severe, stabbing pain and created further health problems.
Pelvic transvaginal mesh acts as internal support and is often made from animal tissue or synthetic materials. It is most commonly used to treat women with stress urinary incontinence (SUI) or pelvic organ prolapse (POP), and is inserted vaginally. SUI is when the bladder releases urine unintentionally, usually due to physical movement. POP is the result of a weakening of the pelvic muscles and can sometimes allow for the pelvic organs to slip out of place. Pelvic transvaginal mesh can help the pelvic organs stay in place and decrease the likelihood of SUI.
Ethicon is a subsidiary of J & J and sells the transvaginal mesh. In 2013, Ethicon briefly decided to pull the product off the market. This was because there were multiple lawsuits and complaints of consumer injuries. Although J & J had been instructed by state regulators to investigate health concerns, it would appear as though there was a failure to make any significant product changes before Ethicon simply began to sell the mesh once again.
Although representatives from J & J say that the company believes that its mesh has been researched, developed and marketed safely, this is not the first time that they have been found responsible for damages. Since 2014 alone, J & J has paid over $35 million in verdicts against them and has settled numerous other cases. In the near future, the company may consider a large-scale settlement with all complainants in order to avoid facing additional litigation.
The Food and Drug Administration (FDA) has categorized transvaginal mesh as a high-risk device. Although the administration categorized it as a moderate-risk in the past, after multiple reports of serious complications arose, the classification was altered. Reports of complications have been reported since the 1990s. The most common complications that the FDA cites are mesh erosion, infection, pain, bleeding, pain during sex, urinary problems and organ perforation. Additionally, pelvic mesh was never tested for transvaginal safety. This means that it was approved for use in other parts of the body, but not for insertion through the vagina.
Because transvaginal pelvic mesh can be dangerous or fatal, it is very important that it is researched and produced in a safe manner. Although certain devices may inherently carry serious risks, these can often be curtailed when a manufacturer behaves responsibly and advocates for consumer safety.
Another trial against J & J is set to start soon, with the plaintiff claiming that she also suffered serious medical injuries as a result of the pelvic mesh. Experts have predicted that over 100 thousand cases against J & J as well as other manufacturers could result from transvaginal mesh implants.
Philadelphia Product Liability Lawyers at Galfand Berger, LLP Represent Individuals Injured by Transvaginal Mesh
If you received a transvaginal mesh implant, and have suffered injuries or suspect that you may have complications as a result, you may be entitled to injury compensation. The Philadelphia products liability lawyers at Galfand Berger can help. With offices located in Philadelphia, Reading, Lancaster and Bethlehem, we serve clients throughout Pennsylvania and New Jersey. To schedule a consultation, call us at 800-222-8792 or submit an online inquiry at www.galfandberger.com.http://blogs.lawyers.com/attorney/medical-malpractice/jj-to-pay-20-million-in-pelvic-mesh-trial-41122/
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