Pelvic Mesh for POP Reclassified as “High-Risk” Device
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Transvaginally implanted mesh to treat POP now classified as high-risk
The FDA has issued a final order reclassifying transvaginal mesh used to repair Pelvic Organ Prolapse (POP) from class II (moderate-risk) to class III (high-risk). The FDA will also require manufacturers of every surgical mesh used to treat POP to conduct a PreMarket Approval application demonstrating the safety and effectiveness of their mesh product for treating POP. Manufacturers have 30 months — two and one half years — to show that their products are safe and effective for POP. These new FDA orders do not apply to mesh sold for Stress Urinary Incontinence (SUI) or abdominal repair.
FDA regulation of pelvic mesh
The first mesh device for POP was approved by the FDA in 2002 . In 2008 the FDA issued a Public Health Notification of what it called “rare” complications — after receiving 1,000 reports of complications from device manufacturers. In July of 2011 the FDA issued a Safety Communication to warn doctors and patients that complications from pelvic mesh were not rare; instead, their own analysis showed that a) 10% of patients who underwent surgery with pelvic mesh suffered mesh erosion within 12 months of surgery and b) mesh used in POP repair does not “conclusively improve clinical outcomes over traditional non-mesh repair.” An advisory panel on pelvic mesh appointed in July 2011 recommended the FDA collect more data; in 2012 the agency ordered manufacturers to conduct post-market surveillance studies
History of transvaginal mesh use
Surgical mesh has been used in surgeries since the 1950s. Gynecologists began using pelvic mesh transvaginally for POP in 1992. The first mesh device sold to treat POP was approved by the FDA in 2002 as a Class II moderate-risk device using the 510(k) process. The manufacturer represented to the FDA that the device was substantially equivalent, just as safe and effective, as a device already on the market. The new FDA orders are a recognition that that claim of substantial equivalence was wrong. Thousands of complaints from women who suffered adverse effects from mesh have been reported to the FDA, including pain, bleeding, mesh contraction, mesh erosion, infection, urinary problems, severe pelvic pain, vaginal tightening or shortening, additional surgeries, painful sexual intercourse, inability to engage in sexual intercourse, or organ perforation. These significant risks must be addressed by manufacturers in their applications for approval.
How is mesh used to treat POP?
Pelvic organ prolapse (POP) is a common medical condition in older women, especially in women who have had children. The internal structure that supports the bladder, uterus, bowel and other pelvic organs becomes so weak, stretched or torn that those organs can drop from their normal position and prolapse (bulge) into the vagina. POP isn’t life threatening, but it causes a host of problems that may include pelvic pressure or low back pain, painful sexual intercourse, constipation, and urine leakage or a chronic urge to urinate. The more common method of implanting mesh is through the vagina as it is less invasive than implantation through the abdomen. The most common side effects of using mesh transvaginally include “severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.”
How many women will need POP?
The numbers of women affected by POP are staggering. 200,000 women undergo pelvic organ prolapse surgery every year. It is the most common inpatient procedure performed on women over the age of 70. In addition, at least 135,000 personal injury lawsuits are pending against the manufacturers of surgical mesh. The personal injury lawsuit number includes pelvic mesh used in Stress Urinary Incontinence (SUI) and other abdominal surgeries; those products are not covered by these new FDA orders, which apply only to mesh devices to treat POP.
What can you do if you have defective pelvic mesh?
Women who experience any of the symptoms we’ve discussed in this post should consult their doctor. If you have suffered complications from a transvaginal mesh implant, call the transvaginal mesh lawyers at Thornton Law Firm for a free, no-obligation consultation. You can tell us your story online or call Attorney Marilyn McGoldrick for a completely confidential evaluation of your legal rights. Time limits for filing claims are short, so contact an attorney as soon as possible.