“501(k) approval process”. from FDA to benefit manufacturers | Searcy Law

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John Hopkins

Surgical Mesh Products are a Prime Example of the Fox Guarding the Hen House

» Written by // September 1, 2011 //


We have written about the Food & Drug Administration process for “quickie” approval of medical devices provided for in the “501(k) approval process”. This involves a manufacturer asking for approval of its medical device because it is “similar to those already cleared” for use by patients. The 501(k) process allows medical device manufacturers to provide information and data to the FDA substantiating that their device is similar to devices already approved on the market and that their device is safe. This saves manufacturers huge amounts of money if safety testing for medical devices. We have also been writing about the dangers posed by surgical mesh used to repair weakened or damaged tissue; most often in the abdominal area of the body. The use by physicians of surgical mesh became popular in “pelvic organ prolapse” (POP) cases. POP occurs most often in 30 to 50 percent of women and is a condition in which tissue supporting a pelvic organ weakens and prolapses into the vaginal area. POP involves bladder, uterus, rectum, bowel and vaginal organs. It is a serious and, sometimes debilitating condition for women. The complications being found involve erosion of the mesh into organs or shrinkage of mesh causing organ entrapment. Nearly all the complications seen with surgical mesh lead to very painful conditions and, often, the need for additional surgeries. So far, based only on actual reports to the Food & Drug Administration, well over 20% of patients have suffered complications. Consumer watchdog, Public Citizen has been calling for the immediate recall and all surgical mesh made of non-absorbable materials: All surgical mesh products made of non-absorbable synthetic material that are used during transvaginal surgery to repair pelvic organ prolapse (POP), a common condition in women, should be recalled because they offer no significant benefits but expose patients to serious risks and the potential for permanent life-altering harm, Public Citizen said in a petition sent today to the Food and Drug Administration (FDA). Joining Public Citizen as co-petitioners were a professor of obstetrics and gynecology at Washington University in St. Louis and a urologic surgeon specializing in female urology and POP at the Mayo Clinic in Rochester, Minn. The FDA is now calling for makers of the surgical mesh, including Johnson & Johnson and Boston Scientific, to submit added safety data to regulators if they want to keep their products on the market. This is the very same material that the FDA should have required and the manufacturers should have submitted prior to the surgical mesh being approved for use in patients. Most of the blame in instances such as this does not fall upon the FDA. The FDA is an underfunded agency asked to approve products and drugs by relying on the thoroughness and honesty of manufacturers. It is manufacturers whose “feet should be held to the fire” to provide ALL information, data and testing before patients are subjected to their products and devices. Like it or not, the 510(k) process is very much like the “fox guarding the hen house”.


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