News on U.S. government agencies, U.S. politics, companies doing business with U.S. federal government. Read U.S. national and local news. This site is not affiliated with United States Government.
(EMAILWIRE.COM, September 06, 2011 ) WASHINGTON, D.C. -- LegalView, a leading online legal resource has updated its vaginal mesh lawsuit portal with information regarding Botox treatment. Vaginal Mesh is one treatment option used to treat incontinence, however it is linked to several serious side effects.
The U.S. Food and Drug Administration approved Botox, or botulinum toxin, to treat incontinence in patients with neurological conditions such as spinal cord injury and multiple sclerosis. This is the seventh condition Botox has been approved to treat since its release in 2002.
Some patients who who have neurological conditions are unable to store urine in the bladder because it is overactive. Botox can be used to relax the bladder so that patients have more muscle control and less leakage.
In two clinical trials involving 691 patients with incontinence due to spinal cord injury or multiple sclerosis, participants who received injections of Botox saw a significant reduction in weekly incontinence, compared to a placebo group. The most common side effects were urinary tract infection and urinary retention.
This new treatment could be a safer alternative for some women to other incontinence treatments like having a transvaginal surgical mesh implanted. One injection may help control incontinence for up to 10 months, says the FDA.
The FDA has found several complications linked to transvaginal mesh and has issued a warning against the treatment. One of the most common complications is mesh erosion where the mesh erodes into other organs and can break through the skin.
Other complications include: mesh migration, mesh shrinkage, pain, painful sexual intercourse, bleeding, infection and painful urination.
Additionally, the FDA says that they have found little scientific evidence that a mesh has any benefit to treating incontinence as compared to other surgical methods. In fact, one of the complications of this device is a reoccurrence of incontinence.
Vaginal Mesh is most commonly used for a condition known as pelvic organ prolapse, or POP. In women who have had a hysterectomy or multiple childbirths, the ligaments and muscles surrounding the bladder, small bowel and uterus become weakened or stretched, causing these organs to slip out of place. A vaginal mesh can be implanted to prevent this from happening.
The FDA initially warned the public about the potential side effects of vaginal mesh in 2008, citing more than 1,000 manufacturer complaints. The FDA wanted physicians to receive specialized training on how to implant the device and warn all of their patients of any complications the agency deemed were serious, but rare.
Unlike drugs, medical devices can get approval without going through a clinical trial phase. Manufacturers only have to show that their device is substantially similar to others on the market.
Many women have filed lawsuits against the makers of these devices because the manufacturers knew of its dangers, but continued to sell and manufacture them anyway.
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.
We are pleased to offer you this exciting, new, and entirely free professional resource. Visit our Free Industry resource center today to browse our selection of 600+ complimentary Industry magazines, white papers, webinars, podcasts, and more. Get popular titles including:
