WASHINGTON – Congressman Brian Fitzpatrick issued a statement following Bayer’s decision to remove Essure, a medical device for women, from the U.S. market.

“Long overdue, Bayer’s decision to remove the unsafe medical device Essure from US markets is welcome news and a major win for patient advocates around the nation. This result is the culmination of years of advocacy of women affected with Essure-related complications, and their activism now ensures that other women will no longer be harmed by this device. Whether relating to Essure or Power Morcellators, advocates from Bucks and Montgomery County are leading the fight and championing medical device reform. We must continue to raise awareness of faulty or harmful medical devices, and advance legislation that protects patients and puts their interests first.”

Since the FDA ordered Bayer to conduct the post-market study and then to add a boxed warning and a Patient Decision Checklist to the labeling, there has been an approximate 70 percent decline in sales of Essure in the U.S. The company stated its decision to halt sales and distribution of the device was due to commercial reasons.

In April 2017, Fitzpatrick introduced the Medical Device Guardians Act [H.R.2163] and Medical Device Safety Act [H.R.2164].

The Medical Device Guardians Act codifies an existing mandate of the American Medical Association’s Code of Medical Ethics, which recognizes that physicians are best equipped to identify and report unsafe medical devices. Additionally, the bill adds physician reports to the list of groups, such as hospitals, already protected from having their reports to the FDA used against them in a civil case.

Currently, the FDA relies on hospitals and industry to identify new safety problems with devices and report them to federal regulators. However, some medical centers are either late in identifying potential safety flaws or fail to report adverse events at all.

The Medical Device Safety Act would ensure that medical device manufacturers are incentivized to maintain the safest, most effective products for patients. This law would remove the blanket liability protections given to medical devices approved under the FDA’s Premarket Approval (PMA). The PMA granted by the FDA completely shields the manufacturer of the device from liability should the device cause severe patient harm or even death. Both Essure and the Power Morcellator were both approved under the FDA PMA.

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