FDA issued a warning to patients and health care providers that surgical mesh placement through the vagina to repair pelvic organ prolapse may pose some signifcant risks.
What Is Pelvic Organ Prolapse
According to FDA, pelvic organ prolapse, POP, occurs when the internal structures that support the bladder, uterus, and/or bowel (the pelvic organs) become very weak or stretched that the organs drop form their normal position and prolapse or bulge into the vagina. Patients who suffer from POP experience disruption of their sexual, urinary, and defecatory functions, pelvic discomfort, and a reduction in the quality of their life.
Mesh is placed through the vagina in order to repair pelvic organ prolapse. However, patients may have a greater risk with the mesh than with other surgical options. There also is no evidence of clinical benefit with the surgical placement of mesh, such as improved quality of life. To repair POP, surgery can be completed through the abdomen or transvaginally, though the vagina, using stitches. It can also be performed with the addition of surgical mesh to reinforce the repair and correct the anatomy.
What Are the Risks
William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDAs Center for Devices and Radiological Health, said, “There are clear risks associated with the transvaginal placement of mesh to treat POP.”
Last year, there were at least 100,000 POP repairs completed with the use of surgical mesh. Of those 100,000 repairs, about 75,000 were transvaginal procedures. FDA received about 1503 adverse event reports associated with mesh used in POP repairs from 2008 to 2010. Out of all these reports, the most common complications, according to FDA, included the mesh becoming exposed or protruding out of the vaginal tissue, infections, bleeding, pain, organ perforation from surgical tools used in mesh placement, urinary problems, and pain during sexual intercourse.
What FDA Recommends for Patients
“-Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;
-Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and
-Those who have had POP surgery but don’t know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their health care provider.”
What Products Pose the Danger
The transvaginal mesh manufacturers linked to these dangerous products include: (1) Bard; (2) Tyco; (3) Mentor; and (4) Johnson & Johnson.
If You Have Questions
If you or someone you love has questions, please contact the law firm of Childers, Schlueter and Smith, LLC based in Atlanta, Georgia. Childers, Schlueter & Smith, LLC attorneys will speak with you free of charge. All inquiries are strictly confidential and will be handled with discretion. Our trained transvaginal mesh implant lawyers are accustomed to handling personal matters like this.