WASHINGTON, D.C. – Congressman Brian Fitzpatrick (PA-08) released the following statement Thursday regarding the passing of Dr. Amy Reed:

“It is with a heavy heart that we say goodbye to Dr. Amy Reed – a recognized physician, exemplary mother and wife, and dedicated patient-advocate. Dr. Reed didn’t ask for the situation she found herself in following a procedure in 2013, but it was immediately evident to anyone that met her - and her family - that she was going to be a fighter, not only for herself, but others. Through her and her loving husband, Hooman’s campaign to bring awareness to the dangers of power morcellators there is no doubt women’s lives have been saved and device manufacturers and regulators have been forced to review their safety protocols and standards. This is Amy’s gift – and we are eternally grateful. My thoughts and prayers are with her dedicated husband and partner, their six children, and entire family. Let our community embrace them in their time of deep suffering and vow to carrying Amy’s legacy and mission with us.”

Due to the advocacy of Dr. Reed and Dr. Hooman Noorschasm, Fitzpatrick introduced the Medical Device Guardians Act which codifies an existing mandate of the American Medical Association’s Code of Medical Ethics, recognizing that physicians are in the best position to identify and report unsafe devices – such as Laparoscopic power morcellators, in Dr. Reed’s case. Additionally, the bill adds physicians’ reports to the list of groups, such as hospitals, already protected from having their reporting to the FDA used against them in a civil case. Similar legislation was introduced by Congressman Mike Fitzpatrick in the 114th Congress.

Earlier this year, Government Accountability Office (GAO) released its long-awaited report on FDA’s approval of power morcellators and the failure of the reporting system to catch this unsafe device. The report confirmed serious gaps in the FDA’s device reporting process, including:

• FDA identified significant deviations from medical device reporting requirements at certain user facilities – including the failure to establish and maintain medical device reporting files.
• Regarding adverse events specific to power morcellators, the Director of the FDA’s Center for Devices and Radiological Health noted that “while these events appeared to be the kind that would have fallen under the agency’s medical device reporting requirements, the agency did not see the corresponding adverse event reports submitted to the FDA’s adverse event report database.” Additionally, it was noted that this is not unique, and that there is limited to no reporting to FDA or to manufacturers are some hospitals.
• Overall, thirty identified articles published between 1980 and 2012 “mentioned or concluded a risk of tissue dissemination following the use of a power morcellator, or the need for a physician to remove all fragments of tissue following a surgery.” Yet it was not until 2014 the FDA acted after receiving a 2013 adverse event report from a patient.

The full report available for download HERE

BACKGROUND:

Laparoscopic power morcellators are used for hysterectomies and to treat uterine fibroids by grinding, or morcellating, them. However, if the blades hit an undetectable fibroid cancer, it will spread the cancer throughout the body, like shrapnel – taking Stage 1 cancers immediately to Stage 4.

Despite this, no one reported this deadly defect to the FDA, until Amy Reed, a mother of six, and a doctor underwent morcellation and her cancer spread throughout her body. Dr. Reed’s patient report to the FDA was the first adverse event report received by the FDA regarding morcellators, despite her same hospital having has a patient harmed by a morcellator one year earlier. After the initial report from Dr. Reed, hundreds of other safety reports began to flow into the FDA. But it should not have fallen upon the patients to bring this to the FDA’s attention.