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Public Citizen Wants Transvaginal Mesh Recalled by Food and Drug Administration

December 31, 1969

Public Citizen, a consumer advocacy group, wants the FDA to recall transvaginal mesh products. The call comes following the federal agency's warning that the medical device may place patients at unnecessary risk of harm without providing sufficient clinical benefit. It was the FDA's second warning about transvaginal mesh. Please contact our Anaheim defective medical device lawyers if you believe that your injuries were caused by transvaginal mesh.

Three years ago, the FDA put out a Public Health Notification and Additional Patient Information on serious complications involving surgical mesh inserted through the vagina for treatment of stress urinary incontinence and pelvic organ prolapse In this latest warning, the FDA wants health care providers and patients to know that serious complications from use of transvaginal mesh are not rare. The federal agency also says that is not certain whether transvaginal POP repair using mesh is a more successful course of treatment than existing non-mesh repair treatments for POP that also pose less risk of complications.

The FDA's review of published scientific literature between 1996 and 2011 also showed that:
• Placing the mesh for POP repair in the abdomen seems to have a lower rate of complication than placing the mesh in the vagina.

• There is a lack of evidence that transvaginal mesh directed at the back wall or the top of the vagina offers greater benefits than surgery without mesh.

• Although surgical repair through the vagina with mesh for tissue weakness between the vagina and bladder provides anatomic benefit than traditional surgery sans mesh does, symptomatic outcomes are not necessarily better.

• Mesh-related complications when used in POP repair are not linked to one particular brand. Mesh contraction and erosion can lead to painful sexual intercourse, the inability to have sex, and serious pelvic pain.

When considering surgical mesh repair to treat POP it is important to know that if there are complications, you may have to undergo additional surgery. Surgical mesh can also put the patient at risk of new complications. Although surgical mesh is a permanent implant, should complications arise, you may have to more surgeries to remove this medical device, which could impair one's quality of life. Other complications linked to mesh include, bleeding, infection, and organ perforation.

It was just last month that our Orange County, California defective medical device lawyers posted a blog about a woman who sued several manufacturers, including American Medical Systems, for Los Angeles products liability. She said the AMS vaginal sling used during her 2009 POP surgery caused her to develop serious complications and injuries. Laura Jones claims that not only did she experience severe pain and develop urinary problems but also she had to undergo several surgeries so the surgical mesh could be taken out.

In 2008, the FDA said that it had received more than 1,000 reports of surgical mesh-related complications involving the treatment of SUI and POP.

Public Citizen wants the FDA to order all mesh makers to recall all their products that are used for transvaginal repair, mandate that new transvaginal mesh devices fall under the Class III device classification, and ban current marketing efforts for current non-absorbable surgical mesh products.

Recall surgical mesh, consumer group says, Star Tribune, August 25, 2011

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, FDA, July 13, 2011

Petition to Ban Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse, Public Citizen

More Blog Posts:

California Defective Medical Device Cases: Lawsuits Filed by Patients Injured by Recalled DePuy ASR Hip Replacement Systems, California Injury Lawyers, August 22, 2011

Woman Files California Vaginal Mesh Lawsuit in Los Angeles Superior Court, California Injury Lawyers, July 5, 2011

Cancer Patient Who Could Lose Breasts Following Experimental Procedures Sues for Newport Beach Medical Malpractice and California Products Liability, California Injury Lawyers, March 11, 2011

Contact Howard Law, PC and request your free Orange County, California products liability consultation. Our Anaheim transvaginal mesh law firm represents clients throughout the county, as well as in Los Angeles County, Riverside County, and San Bernardino County.