Devices

Revoke Morcellator Containment Device Clearance: Petition

A petition submitted to FDA by Philadelphia heart surgeon and power morcellation activist Hooman Noorchashm asks that the agency revoke CDRH clearance of the Advanced Surgical Concepts Pneumoliner containment system use with power morcellators. The petition says that the clearance should be revoked “on the basis of inadequate oncological safety information and testing.” It suggests that options moving forward include banning the device or reclassifying it as a Class 3 device and requiring a PMA assessment. The petition quotes CDRH chief scientist William Maisel as saying that “we want to be clear that, although the device (Pneumoliner) has been shown to successfully contain morcellated tissue, it has not been proven to reduce the risk of cancer spread during surgery.”

Noorchashm says that “from an ethical and public health perspective, this is an astonishing statement and demonstrates the magnitude of the logical (and ethical) error committed by the CDRH leadership in releasing this device into the U.S. marketplace.”

He says that his petition “centers on the fact that the CDRH leadership understands the unacceptable and high risk of iatrogenic cancer upstaging using power morcellation. CDRH also recognizes (and was advised by their expert panel in 7/2014) that the practice of morcellating tumors with malignant potential inside a patient’s body cavity is considered a serious technical error by every surgical specialty, except gynecology. Yet in a shockingly illogical action, the CDRH leadership cleared the Pneumoliner device for use in women without requiring any appropriate clinical trial to demonstrate that this device is, in fact, oncologically safe.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome