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FDA Orders New Testing On Vaginal Mesh Products, Cites Safety Concerns

http://www.youtube.com/watch?v=rWGDjvceKIk

The Wall Street Journal reports that the FDA has ordered the makers of vaginal mesh to conduct clinical studies to further track potential side effects and determine whether the products — which have been used in hundreds of thousands of women — are safe.

The Food and Drug Administration is ordering manufacturers of surgical mesh to conduct new studies of the products when used to treat two conditions affecting millions of women—pelvic organ prolapse and stress urinary incontinence— amid concerns about the products' safety.

The move is the first step toward tighter regulation of the mesh when inserted through the vagina to repair pelvic organs, a less-invasive procedure than traditional surgery. Surgical mesh was initially developed to repair hernias in the 1950s but doctors later adapted the mesh for other uses.

The mesh products, which are made by several companies including C.R. Bard Inc., Boston Scientific Corp. and a unit of Johnson & Johnson, are reviewed under an FDA device-clearance process that doesn't require preclinical tests in patients.

Earlier, we wrote about some of the safety problems plaguing mesh and how women are struggling with long-term pain, infections, nerve damage and other side effects related to the devices.

An FDA spokesperson confirmed that letters are being sent out to vaginal mesh makers. Here's the FDA order and a list of the manufacturers:

FDA Actions: Ordering 522 Postmarket Surveillance Studies

FDA issued the following orders for Postmarket Surveillance Studies:
88 orders for postmarket surveillance studies to 33 manufacturers of urogynecologic surgical mesh for POP [pelvic organ prolapse].
11 orders for postmarket surveillance studies to seven manufacturers of single-incision mini-slings for SUI [stress urinary incontinence].
All manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh for POP and single-incision mini-slings for SUI devices. Data from these studies will enable the agency to better understand these devices and their safety profiles.
Manufacturers that received the order(s) are listed below:

Pelvic Organ Prolapse
ACELL
AMERICAN MEDICAL SYSTEMS INC.
BIO-VASCULAR INC.
BOSTON SCIENTIFIC CORP.
BRENNEN MEDICAL INC
C.R. BARD INC.
CALDERA MEDICAL INC.
COLOPLAST A/S
COOK BIOTECH INC.
COUSIN BIOTECH S.A.R.L
CRYOLIFE INC.
ETHICON INC.
GFE MEDIZINTECHNIK GMBH
HERNIAMESH SRL
KENSEY NASH CORPORATION
MACROPORE BIOSURGERY INC.
MAST BIOSURGERY INC.
MPATHY MEDICAL DEVICES, LTD
NEOMEDIC INTERNATIONAL
ORGANOGENESIS INC.
OSTEOBIOLOGICS INC.
PEGASUS BIOLOGICS INC.
PROMETHEAN SURGICAL DEVICES INC.
PROXY BIOMEDICAL LTD.
RTI BIOLOGICS INC.
SHELHIGH Inc.
SOFRADIM PRODUCTION
SYNOVIS SURGICAL INNOVATIONS
TEI BIOSCIENCES INC.
TEPHA INC.
COVIDIAN (TISSUE SCIENCE LABRATORIES PLC)
W.L. GORE & ASSOCIATES INC
XYLOS CORPORATION

Mini-slings
AMERICAN MEDICAL SYSTEMS INC.
BOSTON SCIENTIFIC CORP.
C.R. BARD INC.
ETHICON INC.
GYNE IDEAS LTD.
MPATHY MEDICAL DEVICES LTD.
PROSURG INC.

Please note, these 522 orders do not cover abdominal sacrocolpopexy (ASC) for treatment of POP or Multi-Incision Retropubic or Transobturator SUI Slings

And then there's this from the FDA's website related to tightening restrictions on vaginal mesh devices by reclassifying them in a higher-risk category:

UPDATE 01/04/2012:

Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.

The FDA continues to assess the safety and effectiveness of urogynecologic surgical mesh devices, through:

Review and analysis of published literature, Medical Device Reports (adverse event reports) submitted to the agency, and post-approval study reports.
Epidemiological research on safety and effectiveness of surgical mesh, as a part of our effort to better understand possible adverse events associated with surgical mesh for SUI and POP.
Collaborations with professional societies and other stakeholders to fully understand the postmarket performance of urogynecologic surgical mesh devices, as well as the occurrence of and signs and symptoms associated with specific adverse events.
Collecting and reviewing all available information about currently marketed urogynecologic surgical mesh devices.
Mandating postmarket surveillance studies (“522 studies”) by manufacturers of urogynecologic surgical mesh devices. On January 03, 2012, the FDA issued:
88 postmarket study orders to 33 manufacturers of urogynecologic surgical mesh for POP; and
11 postmarket study orders to seven manufacturers of single-incision mini-slings for SUI.
The manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices for POP and single-incision mini-sling devices for SUI. Data from the studies will enable the agency to better understand the safety and effectiveness profiles of these devices. For information on the status of the 522 Postmarket Surveillance Studies and the FDA’s authority to order 522 studies, visit the 522 website.

The FDA will provide additional information to the public as it becomes available.

This program aired on January 4, 2012. The audio for this program is not available.

Rachel Zimmerman Twitter Health Reporter
Rachel Zimmerman previously reported on health and the intersection of health and business for Bostonomix.

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