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Ethicon Media Monitoring 09/26/16
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AUGS Defends Polypropylene Mid-Urethral Mesh Slings
Sep 25, 2016 | Mesh Medical Device Newsdesk
This story originally ran last March but is is appropriate as the organization, the American Urogynecologic Society (AUGS) begins its annual conference this week in Denver. -
Dr. Kevin J. Conaway: Pelvic floor disorders common; can be treated without surgery
Sep 26, 2016 | Herald Dispatch
Urogynecology, or female pelvic medicine and reconstructive surgery, is a fast-growing area of women's health. It's estimated that pelvic floor disorders affect one out of every four women, but there are some studies that suggest one in three women will suffer from these disorders during their lifetime.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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AUGS Defends Polypropylene Mid-Urethral Mesh Slings
Sep 25, 2016 | Mesh Medical Device Newsdesk
This story originally ran last March but is is appropriate as the organization, the American Urogynecologic Society (AUGS) begins its annual conference this week in Denver.
Expect to see some discussion of litigation and what doctors should expect in the future from the lawyers who have so far filed more than 100,000 product liability lawsuits against seven manufacturers.
It’s quite a different story from the rosy and profitable picture painted in weekend cadaver clinics and by sales representatives about this “minimally invasive” procedure of mesh implants to treat incontinence and prolapse.
Introduced in the late 90’s, for the next decade, about seven manufacturers couldn’t get their polypropylene (PP) mesh implants to the market fast enough. Some even bypassed any Food and Drug Administration (FDA) approval (Prolift) before the agency caught on three years later.
In 2008, the FDA issued a safety communications after receiving thousands of complaints that mesh problems were “rare” but the agency reversed itself by 2011 saying those same complications were “not rare.”
The FDA, noting a five-fold upswing in complications, ordered post-approval studies to determine how implanted women were faring.
This year, the FDA gave industry 30 months to reclassify mesh for pelvic organ prolapse (POP) to class III or high risk. Manufacturers, facing the challenge and expense of conducting clinical trials, have instead taken their POP mesh off the market- Ethicon removed Prolift, Boston Scientific removed Pinnacle.
Boston Scientific is fighting allegations it imported counterfeit mesh resin from China when its U.S. supplied dried up, and American Medical Systems, sold to Endo, decided in February to close its women’s health division that makes mesh- ASTORA Women’s Health – due to the cost of litigation.
On February 26, 2016, the FDA convened a special panel to consider whether the trocars or stainless steel instruments used in the blind passage of implanting pelvic mesh should be considered of “moderate risk” a move up from their present category they share with band-aids and wheelchairs.
Trocars are used internally in the blind procedure of implanting mesh and have caused organ perforation, bleed-outs and nerve damage.
Considering the above, and the fact that many doctors have been sued by mesh-injured women, might give pause to a medical society and its members to reconsider how doctors fit into the mesh mess.
But it’s not.
In a statement to its members Friday, March 4, the incoming president of AUGS (American Urogynecologic Society) Douglass Hale, MD writes mid-urethral slings are a “treatment worth protecting.”
Hale blamed unpredictable juries who have put mid-urethral slings in the “crosshairs” of our legal system.” Dr. Hale says companies have paid out large settlements and he points to ASTORA (formerly AMS) shutting down as an example, calling it a purely business decision, he says for AMS it was “no longer worth the fight.”
On the contrary he says, the data is overwhelmingly in favor of slings and doctors and patients should still be able to choose this option.
“Despite what some of our own members are saying denouncing these products as unsafe, the data tells a different story that does not support this stance.” ~ Douglass Hale, MDAUGS Defends Polypropylene Mid-Urethral Mesh Slings
MESH NEWS DESK, September 26, 2016 ~ This story originally ran last March but is is appropriate as the organization, the American Urogynecologic Society (AUGS) begins its annual conference this week in Denver.
Expect to see some discussion of litigation and what doctors should expect in the future from the lawyers who have so far filed more than 100,000 product liability lawsuits against seven manufacturers.
It’s quite a different story from the rosy and profitable picture painted in weekend cadaver clinics and by sales representatives about this “minimally invasive” procedure of mesh implants to treat incontinence and prolapse.
Introduced in the late 90’s, for the next decade, about seven manufacturers couldn’t get their polypropylene (PP) mesh implants to the market fast enough. Some even bypassed any Food and Drug Administration (FDA) approval (Prolift) before the agency caught on three years later.
In 2008, the FDA issued a safety communications after receiving thousands of complaints that mesh problems were “rare” but the agency reversed itself by 2011 saying those same complications were “not rare.”
Prolift on eBay July 2013
The FDA, noting a five-fold upswing in complications, ordered post-approval studies to determine how implanted women were faring.
This year, the FDA gave industry 30 months to reclassify mesh for pelvic organ prolapse (POP) to class III or high risk. Manufacturers, facing the challenge and expense of conducting clinical trials, have instead taken their POP mesh off the market- Ethicon removed Prolift, Boston Scientific removed Pinnacle.
Boston Scientific is fighting allegations it imported counterfeit mesh resin from China when its U.S. supplied dried up, and American Medical Systems, sold to Endo, decided in February to close its women’s health division that makes mesh- ASTORA Women’s Health – due to the cost of litigation.
Desara Sling by Caldera
On February 26, 2016, the FDA convened a special panel to consider whether the trocars or stainless steel instruments used in the blind passage of implanting pelvic mesh should be considered of “moderate risk” a move up from their present category they share with band-aids and wheelchairs.
Trocars are used internally in the blind procedure of implanting mesh and have caused organ perforation, bleed-outs and nerve damage.
TREATMENT WORTH PROTECTING
Considering the above, and the fact that many doctors have been sued by mesh-injured women, might give pause to a medical society and its members to reconsider how doctors fit into the mesh mess.
But it’s not.
In a statement to its members Friday, March 4, the incoming president of AUGS (American Urogynecologic Society) Douglass Hale, MD writes mid-urethral slings are a “treatment worth protecting.”
Hale blamed unpredictable juries who have put mid-urethral slings in the “crosshairs” of our legal system.” Dr. Hale says companies have paid out large settlements and he points to ASTORA (formerly AMS) shutting down as an example, calling it a purely business decision, he says for AMS it was “no longer worth the fight.”
On the contrary he says, the data is overwhelmingly in favor of slings and doctors and patients should still be able to choose this option.
“Despite what some of our own members are saying denouncing these products as unsafe, the data tells a different story that does not support this stance.” ~ Douglass Hale, MD
He calls it a “misrepresentation by our legal system” that juries have not seen the realities of these cases.
Never mind that many doctors have also been sued along with the mesh manufacturing putting a chilling effect on the use of mid-urethral slings as well as mesh for pelvic organ prolapse (POP). Never mind that there are more defective product lawsuits filed over alleged injuries from mid-urethral slings than the larger POP mesh, and never mind that juries who have listened to the evidence have decided that the mesh still on the market is defective in its design and in its instructions to doctors.
CORPORATE SPONSORS
UGS will try to sort it all out during its annual convention in Denver, Colorado September 27 to October 1, 2016.
Corporate sponsors can support a program at the platinum level for $75,000 to the copper level at $5,000. One can even have a hotel room key imprinted with a corporate sponsor as this was from the American Hernia Society a few years ago. See the program for sponsorship here.
AUGS is collecting a patient registry of women undergoing treatment for POP to evaluate the effectiveness, quality of life and safety associated with transvaginal/ transabdominal native tissue repair, transvaginal mesh and sacrocolpopexy and a pessary.
It is supported by ACell, ASTORA, Boston Scientific and Coloplast.
In 2014, the PFD Research Foundation received 64% of its funding from corporations. #
http://www.meshmedicaldevicenewsdesk.com/augs-defends-polypropylene-mesh-slings/
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Dr. Kevin J. Conaway: Pelvic floor disorders common; can be treated without surgery
Sep 26, 2016 | Herald Dispatch
Urogynecology, or female pelvic medicine and reconstructive surgery, is a fast-growing area of women's health.
It's estimated that pelvic floor disorders affect one out of every four women, but there are some studies that suggest one in three women will suffer from these disorders during their lifetime.
Some common pelvic floor disorders include urinary incontinence, pelvic organ prolapse and fecal incontinence.
Pelvic organ prolapse describes the vaginal bulge and pressure sensation caused by descent of the uterus, rectum or bladder (sometimes called the "dropped" bladder). Incontinence, or leaking of urine or stool, can have many causes.
It's important to seek out a qualified doctor to treat pelvic floor disorders.
Urogynecologists are obstetrician-gynecologists or urologists who have completed additional training in the evaluation and treatment of these conditions and are dedicated to helping women with these types of disorders.
Who's at risk for PFD? There are a significant number of risk factors for conditions like pelvic organ prolapse and urinary incontinence, including a very common female life experience - vaginal childbirth. Other risk factors for PFD include:
n Smoking
n Menopause
n Age
n Genetics
n Obesity
n Heavy lifting
n Chronic constipation or straining
It is important to realize, however, that PFD is not a normal part of aging.
PFD can affect a woman's quality of life, so treatment for such issues is important. Generally, a physician will recommend a combination of therapies depending on the severity of the condition, the patient's wishes and her general health. The goal of therapy is to relieve discomfort and restore normal anatomy and function.
Treatments can range from lifestyle changes like losing weight and stopping smoking to physical therapy like Kegel exercises, medications, support devices like pessaries and sometimes surgery.
One of the most difficult things to overcome for women with PFD is seeking treatment because of embarrassment or feelings that they are alone.
For many women, just talking about problems such as incontinence or vaginal prolapse is very difficult. However, it's important to remember that physicians and particularly, urogynecologists, are used to discussing these types of medical conditions.
If you or someone you know may be suffering from PFD, it's important to seek out help. Your primary care provider or ob/gyn can help decide if you need to see a specialist.
Dr. Kevin J. Conaway, Fellow of The American Congress of Obstetricians and Gynecologists, is a professor of obstetrics and gynecology at the Marshall University Joan C. Edwards School of Medicine and is Huntington's only board-certified urogynecologist. Conaway is a graduate of Marshall's School of Medicine and completed his residency training at Akron General Medical Center in Akron, Ohio.
http://www.herald-dispatch.com/features_entertainment/pelvic-floor-disorders-common-can-be-treated-without-surgery/article_aa514e49-f733-5e75-9315-516178f893d7.html
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