Following 60 Minutes Report, Shaheen Seeks Answers from FDA on Oversight of Gynecological Mesh Product
**More than two million American women have this mesh implant that can cause severe pain and injury**May 31, 2018
(Manchester, NH)—U.S. Senator Jeanne Shaheen (D-NH) has sent a letter to the U.S. Food and Drug Administration (FDA) seeking answers regarding the agency’s oversight of a gynecological mesh product developed by Boston Scientific Corporation and implanted in more than two million women across the country. Recent reporting by 60 Minutes documents the severe pain and injury that women have experienced after having this mesh implanted. The report claims that Boston Scientific used defective materials in their production process, despite repeated warnings from the device manufacturer’s plastic supplier, Chevron Phillips Chemical Company. The FDA has claimed in a subsequent Boston Globe report that it conducted its own testing of the mesh product and determined that “all samples met the appropriate specifications.” Senator Shaheen’s letter seeks further details on the FDA’s review process and determination regarding this product.
“The claims made in this 60 Minutes report are deeply disturbing and raise important questions regarding the FDA’s oversight of this product,” said Shaheen. “This product has led to painful experiences for many women across the country and they deserve answers about the manufacturing oversight process. Needless to say, a product this invasive should be subject to the utmost scrutiny to ensure the health and safety of the patient, both at the time of the product’s initial approval by FDA and through ongoing post-market oversight after the product is approved.”
Senator Shaheen’s letter to FDA Administrator Scott Gottlieb reads in part, “Both the continued use of the original Marlex polypropylene product following warnings from Chevron Phillips and the subsequent use of the Chinese version of the polypropylene compound raise potential concerns relating to the FDA’s oversight of Boston Scientific’s production activities.”
Her letter continues, “given that the mesh is a medical device, the Food and Drug Administration (FDA) oversaw the approval of the product and is responsible for ongoing post-market oversight of the safety of the device.”
Senator Shaheen’s letter goes on to ask detailed questions of the FDA’s review of the mesh product and can be read in full here.
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