WASHINGTON, D.C. — Congressman Mike Fitzpatrick (PA-8) sent the following letter to the Food and Drug Administration Tuesday regarding dramatic changes in the reporting of adverse events caused by the medical device Essure:
Updated 10:01 AM ET, Tue March 1, 2016
(CNN)The U.S. Food and Drug Administration said it will require a new “black box warning” label for Essure, an implantable permanent contraceptive device. A black box warning in the labeling of products is “designed to call attention to serious or life-threatening risks,” according to the FDA website.
Monday’s announcement comes after more than 5,000 women filed grievances with the FDA between November 2002 and May 2015, complaining of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after an Essure implantation.
Click here to read more: http://www.cnn.com/2016/02/29/health/fda-essure-birth-control-device/index.html
A recent Senate report on Preventable Tragedies states “The current system provides no ability to run data analytics to help identify patterns or to alert FDA to unusual types of reports.”
Here’s the link to the senate report. http://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Report.pdf