FDA Tightens Rules on Pelvic Mesh
January 18th, 2016 | By: Walker Advertising | Posted in: From the CEO
The Federal Drug Administration (FDA) has tightened regulations for surgical mesh products following years of complaints and lawsuits by women who claim they were harmed by such products. The new rules only apply for procedures in which the device is installed through the vagina to repair organ prolapse. This condition, characterized by the weakening of a patient’s vaginal or uterine walls, often occurs after childbirth. It sometimes causes nearby organs to protrude into the vagina.
The new regulations reclassify the mesh from a moderate-risk to a high-risk medical device. Manufacturers must submit data about the effectiveness and safety of these devices before the FDA will allow them on the market.
The FDA’s new regulations do not apply when surgical mesh is used to treat other issues such as stress urinary incontinence, or when mesh to repair organ prolapse is introduced through the abdomen.
According to the Wall Street Journal, surgical mesh was long used in procedures that introduced it through the abdomen. Newer kits designed for procedures that go through the vagina were first approved in 2002. Soon after, the agency began receiving complaints from patients. The FDA first issued safety warnings about the device in 2008. In 2012, the agency ordered manufacturers to collect post-marketing data about the safety of these products.
In lawsuits, women have alleged the devices caused debilitating pain when it eroded into other organs.
The FDA’s move to tighten rules, although it comes too late for many of the women who claim they were harmed by surgical mesh, should be taken as a vindication of these women’s complaints. No medical device should ever be permitted on the market until its safety and effectiveness has been definitely proven.
Unfortunately, it seems like all too often medical devices or medications that are rushed to market then go on to hurt the very patients they are expected to help.
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