By Dr. Michael Wald & Elizabeth Carrollton – Director of Nutrition at Integrated Medicine of Mount Kisco, P.C. (www.drugwatch.com)
914-242-8844 (Ext. 1)
Women who are going through the changes that come with menopause can face some challenging symptoms, including hot flashes, mood swings, weight gain, depression, fatigue and sleeplessness, among many others. Adding to that challenge for many is the fact that pelvic organ prolapse (POP) often occurs with menopause. In 2010, 75,000 women had transvaginal mesh procedures to repair POP. Unfortunately, for as many as one of every 10 of these women, these surgeries resulted in serious complications, causing symptoms more painful and debilitating than the ones they were meant to correct.
Menopause and Prolapse
Pelvic organ prolapse happens when the pelvic floor isn't strong enough to support the organs in the pelvic region effectively, allowing them to slip away from their normal position. The pelvic floor damage that causes POP often begins with changes that occur during pregnancy and childbirth, with other factors that stress the pelvic floor contributing over a woman's lifetime, such as obesity, heavy lifting, and chronic coughing or constipation. Although POP can appear at any age, for most women symptoms appear after the age of 50, when the estrogen loss that comes with menopause causes pelvic floor tissues to lose elasticity, further weakening pelvic support and allowing organs to prolapse.
Transvaginal Mesh Surgeries
About 11 percent of women with pelvic organ prolapse will need reconstructive surgery to address severe symptoms of the disorder. Over the last decade, a large portion of those surgeries have included the use of transvaginal mesh implants to reinforce weakened pelvic tissues, devices that have proven problematic for many women.
Since these devices were approved through the Food and Drug Administration's 510(k) fast-track program, clinical evidence of safety and effectiveness was not required prior to approval. However, as use of these devices grew, a rising number of adverse events reported to the FDA began to raise concern, prompting safety warnings and regulatory action by the FDA. Several transvaginal mesh products have been recalled by manufacturers due to high rates of serious complications, including products made by Boston Scientific Corp., Mentor Worldwide and Johnson & Johnson, and thousands of lawsuits have been filed by women injured by these devices.
Among the most frequently reported complications is mesh erosion, where sharp mesh edges wear through vaginal and pelvic tissues, which can result in organ perforation, pain, bleeding, infection, urinary problems and sexual dysfunction. Mesh shrinkage is also common, and can cause intense pelvic and vaginal pain, vaginal scarring and shortening, and sexual dysfunction. Revision surgeries, often several procedures, have been necessary to resolve symptoms in many women and they are not always effective.
While there are many additional risks with transvaginal mesh procedures as compared to non-mesh surgeries, the benefits are few. Many mesh products have been pulled off the market in a recent transvaginal mesh recall. According to the FDA, mesh procedures have not proven to be more effective than traditional POP repair. The FDA has ordered further research to be done on these products due to the controversy, a move that comes too late to help many women who are struggling with mesh-related symptoms far more devastating than the prolapse problems the surgery was supposed to relieve.
FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
FDA: Surgical placement of mesh to repair pelvic organ prolapse poses risks: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm262752.htm
Harvard Medical School:What to do about pelvic organ prolapse: http://www.health.harvard.edu/fhg/updates/update0805c.shtml
OBG Management: Are new tools for correcting prolapse and incontinence better just because they’re new?: http://www.obgmanagement.com/article_pages.asp?aid=9946