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Jim Bilbo

Bilbo Newsletter

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  • Products Liability
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Product Liability News

FDA recommends surgical mesh be reclassified as "high risk."

Bloomberg News (9/1, Edney) reports, "A Food and Drug Administration staff recommendation" says that transvaginally implanted surgical mesh "products fail to lead to better outcomes than non-mesh repair and should be reclassified as posing a high risk to patients," and the mesh makers "may have to submit added safety data to regulators to keep their products on the market." Bloomberg News adds that a "change in risk classification may take several years to complete and the agency said it could consider a grace period for makers of products on the market to submit data to comply with a more stringent review."

FDA issues warning on vaginal mesh implants.

In a front page story, the Boston Globe (7/14, A1, Kotz, Weisman) reports, "Women who have vaginal surgery to fix a common gynecologic condition called pelvic organ prolapse may wind up with more problems than benefits if a plastic mesh is used, according to a safety communication issued yesterday by the Food and Drug Administration."
        The Los Angeles Times (7/14, Mai-Duc) reports that the "FDA says a review of industry literature and patient reports has shown little evidence that the device improves pelvic organ prolapse, in which a woman's uterus, bladder or rectum can slip out of place."
        The AP (7/13) reported, "About 75,000 women had prolapse surgery with mesh inserted through the vagina last year, and more than 200,000 women had the procedure for incontinence." 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 three years. There were fewer complications among incontinence patients." The FDA's "warning applies only to mesh for prolapse. The agency is also reviewing the use for incontinence, though side effects have not been as frequent."
        The Minneapolis Star Tribune (7/14, Moore) reports, "The most-common complication is when the mesh becomes exposed or protrudes from the tissue, as well as pain, infection, bleeding and urinary problems. Three deaths have been associated with prolapse repair using mesh -- two bowel perforations and one hemorrhage, according to" the FDA. "Dr. William Maisel, the FDA's deputy director and chief scientist in the device division, said there are 'clear risks' associated with the mesh. 'The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed about potential complications.'"
        HealthDay (7/13) reported, "The FDA plans to convene an independent panel of experts to meet and discuss the issue in early September. 'Input from the clinicians, manufacturers and other experts will help the FDA better understand the safety and effectiveness of surgical mesh for [pelvic organ prolapse and stress urinary incontinence] repair, including any changes that would improve our oversight,' Maisel said."

Public Citizen urges recall of surgical mesh for prolapse.
Bloomberg News (8/26, Edney) reports, "Surgical mesh products made by Johnson & Johnson (JNJ) and Boston Scientific Corp. (BSX) to correct falling pelvic organs in women should be immediately recalled because of painful side effects," according to Public Citizen, which said that the "products made of non-absorbable synthetic material can erode and cause pain, bleeding and urinary incontinence." Public Citizen "estimates that 67,500 women" had the products "implanted last year," and "the Food and Drug Administration received 1,503 reports of complications...from January 2008 to December 2010."
        The Minneapolis Star Tribune (8/26, Moore) reports, "FDA spokeswoman Karen Riley said the agency will 'carefully review' Public Citizen's request," and "will hold an advisory committee meeting in September."
        The AP (8/26) reports that the "FDA announced last month that complications with mesh are higher than previously estimated," while "Public Citizen said mesh offers no benefit over traditional surgery with stitches."
        The Newark Star-Ledger (8/26, Todd) explains that "nearly 300,000 women in the US had surgery to correct pelvic organ prolapse," last year. It further points out that under "FDA's controversial 510(k) program," the material was not "required to be studied in patients" before being used. In response to complaints, last month, William Maisel, deputy director of the FDA's Center for Devices and Radiological Health, issued a statement saying, "There are clear risks associated with the transvaginal placement of mesh to treat pelvic organ prolapse," adding, "The FDA...is asking surgeons to carefully consider all other treatment options."

Johnson & Johnson reportedly sold vaginal mesh implant without FDA approval.

Bloomberg News (3/21, Voreacos, Nussbaum) reports, "Johnson & Johnson sold a vaginal mesh implant for three years before US regulators approved the device, now the subject of more than 550 lawsuits by women who claim it injured them." The company "introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an 'innovative and effective surgical option' for weakened pelvic muscles. The US Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product."



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