Articles Tagged with transvaginal

The FDA has recently issued an updated transvaginal mesh warning on the use of the mesh to help repair pelvic organ prolapse (POP). POP occurs when the pelvic organs fall out of place as the result of the stretching or weakening of the tissues holding the organs in place. Transvaginal mesh – also known as vaginal mesh, bladder mesh or a pelvic sling – has been used to surgical correct this condition. However, research has concluded that serious side effects and complications may result due to its use.

These side effects and risks include:

• Bladder perforation
• Pelvic hemorrhage
• Mesh erosion
• Infection
• Pain during intercourse
• Bleeding
• Incontinence

Although some of these effects may be reverse through additional surgeries, others may be life-long, debilitating consequences. According to the FDA – most cases of POP can be treated successfully without the use of transvaginal mesh. The implanting of this dangerous medical device unnecessarily exposes patients to the risk of harm.
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Recently the FDA issued a transvaginal mesh warning concerning the use of the medical device (also known as pelvic mesh, pelvic sling or bladder mesh) as a method to repair pelvic organ prolapse. The FDA warning stated that using transvaginal mesh to repair pelvic organ prolapse exposes patients to an “unnecessary risk” without providing any benefit above safer measures. Next week, the FDA will conduct hearings to determine whether stricter safety measures or a possible recall of the transvaginal mesh is necessary.

Problems from the medical device include pain, bleeding, infection, injury to nearby organ, and protrusion of the mesh through the vagina.

If you have undergone surgery for pelvic organ prolapse and surgeons used the pelvic mesh, it is important to consult with a transvaginal mesh attorney regarding your next steps.

According to an FDA representative, “There are clear risks associated with the transvaginal placement of mesh…The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh.” This warning came after the FDA received reports of 1503 adverse events from 2008 to 2010.
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