Breast Implant Working Group’s Comments on FDA’s Draft Guidance to Improve Patient Communication on Breast Implants

December 23, 2019. We are urging that the FDA require a black box warning and Patient Informed Consent Check List that provides information about the risks of cancer, breast implant illness, and other serious health problems in explicit and easy-to-understand wording that all individuals considering breast implants can understand, regardless of educational level or stress that is inevitable when a person  is considering surgery.

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NCHR Comments on FDA’s Draft Guidance on Post-Market Studies and Clinical Trials

December 20, 2019. Post-market clinical trials and other studies can help inform FDA and the public about the risks and benefits of medical products.  However, when they are relied upon to answer questions better addressed prior to approval, or if less effective studies or trials are used, or if studies are delayed and inadequate, they do not provide the intended data that is needed by FDA, patients, and healthcare providers.  This adds to the already high cost of medical care.

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NCHR Testimony on Tazemetostat for Epithelioid Sarcoma

December 18, 2019. We can all agree that there is a need for better treatment options for patients with epithelioid sarcoma. We can also agree that new treatments still need to have a real and meaningful benefit to patients. Just as important, there needs to be enough information about this treatment option so that patients and their physicians can determine if the benefits outweigh the risks for each patient, so they can decide whether or not to try it. There can be differences of opinion on what would be a meaningful benefit and what is a likely risk, and those will vary for individual patients.

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