February 21, 2013. Yesterday the FDA quietly approved yet another questionable style of breast implants, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant made by Allergan, Inc. Unfortunately, Allergan’s studies did not compare the safety and effectiveness of the Natrelle 410 implant to other previously approved silicone gel-filled breast implants on the market.
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Testimony to FDA Advisory Committee on NeuroFlo
December 10, 2012. Dr. Yttri tesifies to the FDA that the clinical utility of the NeuroFlo device for the SENTIS subject population should be carefully assessed, considering both the lack of benefits and increased risks with an unnecessary procedure.
Read More »NCHR Testimony to FDA Advisory Committee on Bedaquiline
November 28, 2012. Dr. Yttri testifies to the FDA Committee that the data on bedaquiline indicate that the benefit to patients with multi drug resistant tuberculosis is questionable. The FDA’s responsibility is to approve drugs that will help, not harm, consumers. Treatments exist for patients with multi drug resistant tuberculosis that are safer without the addition of bedaquiline.
Read More »Testimony to FDA Advisory Committee on Intra-Aortic Balloon Pumps
December 5, 2012. We strongly agree with the FDA that IABP devices used to treat septic shock and Intraoperative Pulsatile Flow Generation should remain Class III, with PMAs required. The evidence of safety and effectiveness for these indications has yet to be established.
Read More »Testimony to FDA Advisory Committee on External Counter-Pulsating (ECP) Devices
December 5, 2012. We do not support the FDA’s recommendation to down-classify ECPs for refractory chronic stable angina. We would support allowing the ECPs that are currently on the market to be allowed to stay on the market with labeling to include the phrase “all 510(k) cleared ECPs are prohibited from being used for any indication other than refractory chronic stable angina.” We urge you to require all new versions of ECPs to be classified as Class III and go through the more rigorous PMA process for any uses.
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