The Recall Lawyers

On January 4, 2012, the FDA announced that it is considering changing the classification of transvaginal mesh from a Class II to Class III medical device.

What is the difference between Class II and Class III?

A Class III device requires "an independent assessment of safety and effectiveness during a premarket review." Basically, a Class III drug goes through rigorous trials before it is approved by the FDA for use. A Class II device, on the other hand, may be exempt from this kind of testing or premarket review.

How did transvaginal mesh get approved by the FDA in the first place?

For most Class II devices, they are not required to go through premarket review because of the FDA's 510(k) submission process. This process allows drug companies to get their devices approved by the FDA by claiming that they are "substantially equivalent" to a device that has already been approved. 168 transvaginal mesh devices on the market became FDA approved through this process.

Was there any kind of testing of transvaginal mesh?

There were lab studies and animal studies that drug companies submitted to the FDA. There were no human studies.

If transvaginal mesh is reclassified from a Class II to Class III device, companies that make these devices will be required to go through postmarket surveillance studies. According to FDA policy, this process can take up to three years. It could have a very significant impact on some of the ongoing lawsuits brought by women and their spouses who have been injured by transvaginal mesh.

What is transvaginal mesh?

Transvaginal is mesh that is used in the vagina for certain surgeries to treat one of the following conditions:

• Pelvic Organ Prolapse (POP). For more information on POP, click http://www.the-recall-lawyers.com/2011/09/fda-to-hold-transvaginal-mesh.html#more
• Sudden Urinary Incontinence (SUI). This is a condition that occurs when a woman is unable to prevent urine from leaking from her urethra. There are many known causes, the most common of which is pregnancy. Multiple pregnancies may cause this condition to become permanent.

Continue reading "FDA Considers Requiring More Studies of Transvaginal Mesh" »

Following two days of meetings on transvaginal mesh, the FDA said it would require two makers of vaginal mesh, Johnson & Johnson and C.F. Bard Inc., to conduct clinical studies and present safety information on the use of mesh to treat Pelvic Organ Prolapse (POP).

The FDA had initially approved mesh under a summary proceeding requiring no preclinical testing. However, now at least seven deaths have been linked to its use. Problems caused by vaginal mesh have been described as extremely painful and include organ perforation, bleeding, and infection. Such complications may require corrective surgery.

Continue reading "FDA to Require Transvaginal Mesh Clinical Trials" »

The Food and Drug Administration plans to hold a subcommittee meeting to discuss "the safety and effectiveness of transvaginal surgical mesh for repair of pelvic organ prolapse" this week on September 8 and 9. This meeting comes at a time when consumer groups are calling for the widespread recall of surgical mesh due to severe complications.

Tranvaginal surgical mesh is used to treat Pelvic Organ Prolapse, a condition that occurs when the support in the vagina is lost which results in the dropping of the bladder, urethra and other pelvic organs. Vaginal mesh has also been used to treat Stress Urinary Incontinence, a condition that occurs due to weakening of the pelvic area muscles and causes short bouts of incontinence.

The FDA first warned of serious complications from transvaginal surgical mesh in October of 2008. It warned of erosion through vaginal epithelium--the wearing away of the thin lining covering the vaginal wall. Surgical mesh has also been linked to infection, pain, urinary problems, bowel, bladder or blood vessel perforations.

Continue reading "FDA to Hold Transvaginal Mesh Hearings This Week" »