Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Thursday, May 16, 2013

Wall Street Journal on Surgical Mesh Post-Market Surveillance Study


Updated May 14, 2013, 4:08 p.m. ET

By SHIRLEY S. WANG   Wall Street Journal   FiDA highlight
A new study finds that long-term benefits are limited for many women who undergo an operation to treat a common condition called pelvic organ prolapse, which can lead to urinary problems and discomfort.
The surgery, called abdominal sacrocolpopexy, has been the standard treatment for the gynecological condition for more than three decades, but its outcomes rarely have been studied systematically beyond two years. In addition, there isn't agreement among doctors about what constitutes success for the procedure.
In pelvic organ prolapse, the uterus or vaginal walls "drop" after childbirth and sometimes protrude into or out of the vaginal opening. Most women who have had children vaginally have some degree of prolapse but may not notice symptoms, which can include feeling a bulge in the vagina, a delay in urinary stream and difficulty with defecation.
For some 225,000 women a year in the U.S., the symptoms become so problematic that they get surgery.
Two procedures, abdominal sacrocolpopexy and a type of vaginal surgery, are used to prop up or anchor the organs to keep them in place, sometimes with the use of synthetic mesh. A third operation, used only rarely for older women, closes up the vagina.
The new study, published Tuesday in JAMA, the Journal of the American Medical Association, followed the outcome of more than 200 women for an average of seven years after sacrocolpopexy surgery. It is one of the longest follow-ups to date of such patients.
The study showed that many women receive short-term relief from symptoms and most don't need repeat surgery, but a substantial portion—some 25%—see some symptoms recur over time, and more than 60% develop urinary incontinence, sometimes as a result of the surgery itself.
"Surgery for pelvic organ prolapse isn't perfect," said Ingrid Nygaard, first author on the study and a professor of obstetrics and gynecology at the University of Utah School of Medicine. "It is very good at alleviating symptoms and improving quality of life, but the results may not last forever."
For those who had mesh implanted as part of the procedure, some 10% experienced movement of the mesh from its original location, which "may cause problems for years down the road," said Dr. Nygaard.
The use of synthetic mesh in a related pelvic organ prolapse procedure, in which the mesh is inserted through the vagina rather than through the abdomen, is the subject of hundreds of product-liability lawsuits against mesh makers. The suits allege the women were injured when the mesh failed.
Mesh contraction can occur in the vaginal procedure and cause pain, but mesh movement with the abdominal surgery is unlikely to be painful, according to Dr. Nygaard, who has no ties with mesh makers.
Strategies to prevent pelvic organ prolapse center on pelvic-muscle exercises and childbirth through cesarean section. Some studies have shown such exercises to be effective, and one large epidemiological study in Sweden suggested a link between C-sections and lower risk of the condition. But the preventive effect of C-sections hasn't been studied in a randomized trial.


Further reading:

Jane Akre:  Mesh Device News Desk
http://meshmedicaldevicenewsdesk.com/featured-articles/mesh-fails-25-percent-of-time-in-vaginal-prolapse-repair/

 Ingrid Nygaard:
http://healthcare.utah.edu/fad/mddetail.php?physicianID=u0513310
Study Press Release:
http://www.eurekalert.org/pub_releases/2013-05/tjnj-sel050913.php

JAMA study:
http://media.jamanetwork.com/news-item/study-evaluates-long-term-effectiveness-of-surgery-for-pelvic-organ-prolapse/




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