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FDA Issues Warning About Use of Mesh In Certain Surgical Procedures

Photo of Randy Sorrels

Women who have undergone certain surgical procedures involving the placement of surgical mesh are being warned by the Food and Drug Administration that the added risk associated with the surgical mesh may outweigh the intended benefit. Earlier this month, the FDA released an updated safety bulletin warning health care providers and patients that this product (commonly used in surgery to treat pelvic prolapse) may increase the risk of pain, bleeding and infection in women - as compared to women who have traditional surgery with stitches.

It is estimated that more than 500,000 women undergo surgery for pelvic prolapse and incontinence annually, and many of these involve this type of mesh. The surgery can be performed through the abdomen or transvaginally, using this surgical mesh to reinforce the intended surgical repair and correction of the anatomy. The FDA received more than 1,500 reports of complications between 2008 and 2010, which represented a 500 percent increase over the previous three years. This warning is intended for patients who have the mesh inserted for prolapse only. The FDA thinks as many as ten percent of women who have had the mesh inserted suffer complications within the first year of surgery. The preferred method of treatment involves the removal of the mesh through additional surgical procedures.

It is recommended that the patient become aware of the additional risks associated with the use of this mesh and ask the surgeon about the different options, including those that do not involve mesh. If you have suffered from an injury involving this mesh, consider contacting a lawyer to more fully understand if you have any legal remedies available to you.

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