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(EMAILWIRE.COM, October 05, 2011 ) PHILADELPHIA, P.A.- LegalView, a leading online legal resource, supports stricter screening and pre-market control over the medical device, vaginal mesh. Johnson & Johnson and other vaginal mesh manufacturers have agreed that stricter standards should be in place as well.
Additionally, LegalView supports an increase in clinical trials prior to market release and that the device should be changed from a class II medical device to a class III medical device. As a class III medical device, vaginal mesh would be subjected to more clinical trials, research, and more more stringent controls.
Vaginal mesh has been linked to several serious complications, including mesh erosion where the device can erode into surrounding organs and break through the skin. Another serious complication can occur when the device perforates the bladder. Other complications include infection, painful sexual intercourse, bleeding, painful urination, and reoccurrence of prolapse.
Vaginal mesh is a synthetic mesh that is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It can be implanted either abdominally or vaginally.
POP is a condition common in women who have been through childbirth or who have had a hysterectomy. The condition occurs when the muscles and ligaments that hold the pelvic organs in place become so stretched and weakened that they can no longer hold the pelvic organs in place. The bladder, small bowel, uterus, rectum, and vagina are most likely to prolapse.
SUI occurs when there is an involuntary loss of urine which is caused by insufficient strength of the pelvic floor muscles. In women, physical changes that occur after menopause, childbirth, or pregnancy can contribute to SUI. The loss of urine occurs most during physical activity like coughing, sneezing, laughing, or exercising.
According to the U.S. Food and Drug Administration, more than 100,000 women have received vaginal mesh to treat either POP or SUI in 2010. Of those, 75,000 have had transvaginal surgical mesh implanted via the vagina. Patients claiming of adverse vaginal mesh implants have filed more than 500 lawsuits against several manufacturers, including Johnson & Johnson.
In 2008, the FDA first started warning about the dangers of vaginal mesh. The agency wanted physicians to receive specialized training to learn how to correctly implant the device and tell their patients about any complications.
In August 2011, the agency released a formal warning about the device. To follow up, they convened a meeting with outside experts to determine the next regulatory steps with regards to the device. It was decided that there should be more clinical trials and that the device should become a class III medical device.
Currently, the device is classified as a class II. Under this system, a medical device can get FDA market approval if the manufacturer can show that the device is significantly similar to others like it on the market.
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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