Devices

FDA Still Against Using Morcellators for Most Fibroids

An updated FDA assessment of the use of laparoscopic power morcellators (LPMs) to treat uterine fibroids says the agency continues to caution against their use in the majority of women undergoing myomectomy or hysterectomy to treat fibroids. “While minimally invasive surgery conveys several advantages over open surgery for women with fibroids including reduced recovery time and rate of wound infection” the agency says, “the use of LPMs during these surgeries poses a risk due to unsuspected uterine sarcoma.”

FDA’s concerns were first outlined in a 2014 safety communication that discouraged use of the products for this indication. “Women with unsuspected uterine sarcoma who undergo morcellation of presumed benign fibroids are at risk for mechanical spread of cancerous tissue and worsened clinical outcomes,” the notice says.

For its updated review, CDRH assessed (1) the prevalence of sarcoma in women undergoing myomectomy or hysterectomy for presumed benign uterine fibroids; (2) clinical outcomes for patients diagnosed with cancer following morcellation (power or manual) during myomectomy or hysterectomy to treat presumed uterine fibroids; and (3) differences in patient outcomes for women who have undergone electric power morcellation compared to manual morcellation and/or no morcellation. It also reviewed medical device reports received by FDA for dissemination of malignancy following LPM use as well as information related to changes in rates of hysterectomy or myomectomy procedures performed since the 2014 safety communication.

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