Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Pennsylvania Lawmaker Wants Power Morcellators Reviewed In Cancer 'Moonshot' Initiative

This article was originally published in The Gray Sheet

Executive Summary

Pennsylvania Republican Congressman Mike Fitzpatrick sent a letter to Vice President Joe Biden asking for reforms to medical device review processes, and for a sharper look at power morcellators that he said spreads cancer as part of the administration's cancer "moonshot" initiative.

You may also be interested in...



Dr. Amy Reed, Anti-Power Morcellator Activist, Dead At 44

Anesthesiologist Amy Reed, who with her cardiologist husband Hooman Noorchasm turned her battle against uterine cancer into a crusade to abolish unsafe uses of power morcellators, died May 24 at her home in Yardley, Pa., at the age of 44.

US FDA: Ultrasonic Tools Shouldn't Be Used For Uterine Surgery

Draft guidance issued Nov. 10 recommends manufacturers of surgical aspiration devices add a contraindication to their product labeling stating the tools are not for use in uterine surgery. This is due to a perceived risk of spreading cancerous tissue, which also led to a similar warning on power morcellation devices in 2014.

Six-Year Study Will Compare Bayer’s Essure With Tubal Ligation

US FDA has accepted a post-approval study plan by Bayer HealthCare for its Essure permanent sterilization device, which is under intense scrutiny in response to adverse events and charges of clinical trial misconduct. The protocol entails a non-randomized, six-year cohort study comparing Essure-implanted women to tubal ligation sterilization subjects.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034686

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel