Devices

FDA Order to Restrict Bayer’s Essure Use

FDA has issued an order that will restrict the use of Bayer’s controversial Essure birth control device to ensure that all women considering the device are provided with adequate risk information. The agency action is in response to it becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted. Earlier this year, FDA said it received 11,854 medical device reports related to the device in 2017, more than double the 5,019 reports received in 2016 (see story). Since FDA ordered Bayer to conduct a post-market study two years ago, and then to add a boxed warning and a patient decision checklist to the labeling, there has been about a 70% decline in the device’s sales in the U.S.

“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” FDA commissioner Scott Gottlieb is quoted in a release as saying. “Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”

The new Essure labeling restricts the sale and distribution of the device to only health care providers and facilities that provide a patient brochure, titled “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement,” that must be reviewed with the prospective patient by the health care provider. “The patient must be given the opportunity to sign the acknowledgment, and it must be signed by the physician implanting the device,” FDA says. “Bayer, the device manufacturer, is required to implement the restrictions immediately and ensure that the process going forward results in health care provider compliance with the sales restriction. The FDA will review and monitor Bayer’s plan to ensure the company complies with the restriction. The FDA plans to enforce these requirements and will take appropriate action for a failure to comply, including applicable criminal and civil penalties.”

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