Surgical and Transvaginal Mesh - FDA Warnings

 

Surgical and Transvaginal Mesh
FDA Warnings Symptoms and Complications  

 

Transvaginal Mesh News

FDA reevaluating vaginal mesh implants  >>
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FDA Warning on Transvaginal Mesh
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In October of 2008, the FDA issued initial warnings about the potential side effects of the use of Transvaginal mesh.

In February of 2009, the FDA began warning healthcare professionals of the “rare” but serious compilations associated with the use of Transvaginal mesh.

On July 13, 2011, after a search of its Manufacturer and User Device Experience (MAUDE) database as well as its own systematic review of the scientific literature in regards to POP and SUI surgical mesh safety and efficacy, the FDA issued an Updated Safety Communication. The updated alert warns that surgical placement of mesh through the vagina, specifically to repair POP, may expose patients to greater risk than other surgical options.

The FDA determined that:

1) Serious adverse events are NOT rare. It is estimated that 10 percent of all Transvaginal mesh clients experience adverse effects within the first 12 months.

2) Transvaginally placed mesh in POP does NOT improve clinical outcomes over traditional non-mesh repair.

Surgical and Transvaginal Mesh Lawsuits

If you have experienced failure of Transvaginal Mesh, you may be eligible for financial compensation for lost wages, medical bills and other expenses. Please contact the attorneys at Levin Simes Kaiser & Gornick, LLP today at 1-877-852-2111 for a free case evaluation.

To submit an on-line inquiry regarding Transvaginal Mesh, please fill out the form below.

 

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