FDA issues warning about pelvic mesh complications used in vaginal prolapse surgery
U.S Health officials in the Food and Drug Administration (FDA) are warning that a product commonly used in surgery to address pelvic collapse and other women’s health problems causes a lot more complications than was previously thought and is likely exposing patients to unnecessary risks. The FDA last week issued a statement that women who have had surgical mesh implanted to support their reproductive organs are at greater risk of pain, bleeding and infection that women who have traditional surgical procedures with stitches.
Problems with vaginal mesh have been associated with products made by a number of different manufacturers, including C.R. Bard, American Medical Systems (AMS), Boston Scientific, Johnson & Johnson and others. Dr. William Maisel, the FDA‘s chief scientist and deputy director of the center for devices said that “The added benefit of using the mesh is not evident but there certainly appears to be an added risk.”
Pelvic prolapse and urinary incontinence surgery are common procedures in the United States. More than half a million women undergo surgery for these problems each year though not all procedures involve mesh. About 75,000 had prolapse surgery with mesh inserted through the vagina in 2010 and more than 200,000 women had the procedure for incontinence. There is a less common version of the procedure where the surgeon inserts the mesh through the abdomen, and the FDA reports fewer complications are associated with that method.
Between 2008 and 2010 the FDA received more than 1,500 reports of complications from women undergoing vaginal prolapse surgery with mesh, up 500 percent from the prior 3 years, and there were fewer complications among patients getting surgery for urinary incontinence. The warning the FDA issued on Wednesday July 13th applies only to mesh used for the prolapse procedure. Doctors who perform the procedures say the incontinence surgery uses less mesh, possibly resulting in fewer complications.
The FDA conceded that a 200 public notice it issued describing problems with the mesh as “rare” was a mistake: after reviewing the literature over the last 15-years, the FDA now estimates the most common problems occur in 10 percent of women within a year of surgery, and these patients often undergo multiple surgeries to remove the mesh.
Even though there is a high rate of injury the FDA‘s top device scientists says the government will NOT withdraw the product because certain patients may still benefit. Patients who have suffered through mesh-related complications however say the device should be banned in all but the most dire cases, such as Lina Keeton of Miami, Florida who has undergone 17 surgeries to remove mesh implanted in 2001. Her group Truth In Medicine has been lobbying the FDA on the risks associated with mesh.
The FDA will hold a two-day meeting in September to discuss studies that would identify which patients would benefit most from mesh implants. Studies of that type usually take years and millions of dollars. For now Dr. Maisel said surgeons should first consider traditional prolapse surgery in which the pelvic floor is re-positioned and tightened using stitches. Even though the procedure is safe it has a 20-45% failure rate, which is what lead doctors to first begin using the surgical mesh.
Medical device manufacturer and marketer C.R. Bard introduced its Avaulta Anterior and Posterior BioSynthetic Support System in 2007: a number of lawsuits have been filed by women who experienced complications with the system. The lawsuits allege CR Bard negligently designed the product and failed to warn patients of possible complications that can result in serious complications and physical pain.
The Food and Drug Administration’s Alert Notice can be read here. You can click here to download the 15-page FDA document titled “Urogynelogic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.”
If you have experienced serious complications due to placement of surgical mesh during surgery for pelvic prolapse, contact Smith & Hassler for a free evaluation of your products liability claim.