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(EMAILWIRE.COM, September 26, 2011 ) PHILADELPHIA, PA -- LegalView, a leading online legal resource has updated its vaginal mesh portal regarding a potential vaginal mesh recall. The United States Food and Drug Administration met with outside experts to discuss vaginal mesh and the regulatory steps necessary for the surgical device that has been linked to several serious complications.
The meeting attendees determined that it was necessary to create stricter pre-market procedures and to reclassify the device as a class III device. Under these new rules, vaginal mesh manufacturers will be required to perform pre-market testing.
Despite calls from public advocacy groups to ban the marketing of the device and to recall currently available products, the panel made no call to do this. The reason for this, says the FDA, is that they do not have solid, scientific studies to back-up a recall. The FDA would like to see more randomized, controlled or cohort studies that cover a period of three years.
Currently, manufacturers of vaginal mesh only have to show that their products are “substantially similar” to others that are currently on the market before they are approved for sale.
Since 2008, the FDA has received more than 2,000 adverse event reports of complications following surgery, and of those, approximately 1,500 of these with transvaginal surgical mesh implants used in POP repair and about 1,400 associated with stress urinary incontinence.
Vaginal mesh is a synthetic mesh used to treat two conditions, pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
SUI occurs when there is an involuntary loss of urine during physical activity such as, laughing, coughing, sneezing or exercising. Common causes of this condition include: childbirth, getting older, persistent cough or obesity.
POP occurs when the ligaments and muscles that hold the pelvic organs in place become so stretched and weakened that they cannot hold the pelvic organs in place and descend into the vagina. The most common organ to prolapse, or descend, is the bladder, but sometimes the rectum or uterus will prolapse into the vagina.
According to the FDA, vaginal mesh implants are associated with risks such as bleeding, infection, and perforation into the bladder. Some of the long-term consequences that may occur are: painful sexual intercourse (dyspareunia), pelvic pain, infection, and the need for additional surgeries to correct the complications. One of the most common and consistently reported complication is one in which the mesh erodes into surrounding organs and can protrude through the skin.
The FDA first started making warnings about this device in 2008. Then, the agency wanted surgeons to receive specialized training on how to implant the device and tell their patients about any side effects that the FDA deemed were serious, but rare.
About LegalView:
LegalView is a public service brought to you by Legal WebTV Network, LLC, a Limited Liability Corporation created by a group of the nation's most highly respected law firms: Anapol Schwartz; Cohen, Placitella and Roth; James F. Humphreys and Associates; and Lopez McHugh. For more information on the accomplishments and track records of LegalView's superior sponsoring law firms and to get in touch with LegalView attorneys, visit LegalView at www.Legalview.com.
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