Tags
Center for Devices and Radiological Health, Food and Drug Administration, Prolapse, Silver Spring, Silver Spring Maryland, U.S. Food and Drug Administration, Urinary incontinence, Vagina
LegalView Announces New Vaginal Mesh Litigation Portal
LegalView, an online legal resource, will ow offer free legal case evaluations regarding the surgical implant, vaginal mesh.
Free legal consultations and additional information regarding pelvic organ prolapse or vaginal mesh repair is available at LegalView.
(PRWEB) August 29, 2011
LegalView, a leading online legal resource and consortium of personal injury lawyers, now offers free legal consultations for vaginal mesh litigation. The new informational portal page can be found at http://vaginalmesh.legalview.com/.
Vaginal mesh, or transvaginal mesh, is a surgical device that is implanted through the vagina or abdomen to improve a pelvic organ prolapse, a condition where a woman’s uterus, bladder or rectum slip out of place due to weakened muscles or ligaments as a result of surgery or childbirth.
The U.S. Food and Drug Administration concluded that there was little evidence to support the claim that vaginal mesh improves pelvic organ prolapse, and doctors should notify patients of the potential risks and long-term side effects of prolapse surgery using vaginal mesh.
Vaginal mesh side effects include:
- Mesh erosion or protrusion of the mesh into soft tissues
- Pain, including during sexual intercourse
- Increased risk of infection in mesh area
- Mesh contraction resulting in vaginal shrinkage
- Organ perforation
- Incontinence
- Bleeding from mesh site
- Damage to nearby organs, which may be permanent
The FDA has previously issued warnings regarding vaginal mesh and recommended physicians receive special training to reduce implant complications. Unfortunately, more than one thousand reports of complications or complaints have been lodged against various mesh manufacturers since 2008.
Unlike prescription medication, medical devices are not required to undergo a formal clinical trial period prior to FDA approval. According to the FDA, manufacturers only need to show that the device is substantially similar to other products already on the market. The FDA has announced that a panel of experts will determine how to proceed during a meeting scheduled for September 2011.
Additional surgeries are often required to remove or repair the mesh. William Maisel, MD, the deputy center director for science at the FDA’s Center for Devices and Radiological Health in Silver Spring, Md. reports that because vaginal mesh is a permanent implant, surgeons may be unable to fully remove it. Women who are currently experiencing vaginal mesh complications may not immediately link current gynecological problems with an older surgery.
Free legal consultations and additional information regarding pelvic organ prolapse or vaginal mesh repair is available at LegalView.
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 http://www.Legalview.com.
Related articles
- Industry planning response to calls for transvaginal mesh recall (earlsview.com)
- FDA Should Recall Surgical Mesh for Women, Public Citizen Says (earlsview.com)
- UK – It was a simple implant to cure an embarrassing problem… The incontinence operation that’s ruining women’s lives (earlsview.com)
- FDA 510K Process – Another Issue – Risky pelvic mesh highlights worries about FDA process (earlsview.com)
- Industry planning response to calls for transvaginal mesh recall (medcitynews.com)
- FDA: Repairing Pelvic Organ Prolapse With Surgical Mesh Risky (webmd.com)
- FDA issues a second warning on synthetic mesh used to repair organ slipping in women ()
- Advocacy group seeks ban on pelvic surgical mesh (sfgate.com)
- Is mesh reinforcement the only solution to treat prolapses? (via Woman’s World) (pelvicfloor.wordpress.com)
- FDA warns against surgical mesh to repair pelvic problems (boston.com)
Pingback: J&J-Led Vaginal Mesh Group Says FDA Should Require More Studies « Earl's View
Pingback: The Next Medical Device Controversy: Vaginal Mesh « Earl's View
Pingback: Vaginal / Pelvic Mesh lawsuits pile up for C.R. Bard « Earl's View