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Although the Food and Drug Administration approved surgical mesh for use in pelvic organ prolapse (POP) in 2002, the controversy surrounding its use continues to grow. Doctors often favor this method of POP surgery, claiming it is simpler and less invasive.
However, the FDA and some medical professionals contend that surgical placement of mesh through the vagina may expose patients to greater risk than other surgical options.
In 2002, the FDA approved surgical mesh for POP. Prior to 2002, the FDA had approved surgical mesh for use in stress urinary incontinence (SUI) and hernia repairs. SUI is caused by leakage of urine during moments of physical stress.
In 2008, the FDA issued its first warning regarding surgical mesh for POP. In 2011, the FDA issued an updated warning regarding the use of surgical mesh in POP repairs.
In 2016, the FDA reclassified transvaginal mesh products by designating them as Class III, which generally includes high-risk devices. The FDA also strengthened the approval process requirements for surgical mesh for transvaginal repair of POP.
A POP occurs when a pelvic organ, such as the bladder, drops (“prolapses”) from its normal position and pushes against the walls of the vagina. This can happen if the muscles that hold the pelvic organs in place become weak or stretched from childbirth, surgery, or the aging process.
More than one pelvic organ can drop at the same time. Organs that can be involved in POP include the bladder, uterus, bowel and rectum, or, after a hysterectomy, vaginal vault prolapse. In this case, the vagina collapses in upon itself because of the removal of the uterus.
According to the FDA, although rare, complications did occur. Patients who have had a POP may experience:
Are you suffering from any of these complications resulting from transvaginal mesh surgery? If so, you may be entitled to compensation.
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