Montana Congressman Ryan Zinke helped introduce the bipartisan Medical Device Guardians Act (aka Guardians Act), which requires physicians and physicians’ offices be added to the list of entities that must report unsafe medical devices to the device manufacturer and the Food and Drug Administration (FDA). Zinke helped introduce the bill with Rep. Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) after speaking with Ray Curtis from Missoula, whose wife Nancy Curtis died as a result of a procedure with a dangerous medical device, a Laparoscopic Power Morcellator, which could have been prevented had the proper information been known ahead of time.

Laparoscopic Power Morcellators have resulted in the death of women across America for decades. These devices, used in otherwise routine hysterectomies and treatment of uterine fibroids, have caused undetected, stage one cancer to jump immediately to stage four, making the cancer nearly impossible to treat and resulting in needless loss of life of hundreds, if not thousands of women. It is difficult to know just how lethal some of these devices have been without proper reporting. The Medical Device Guardians Act would require doctors to report incidences in which Laparoscopic Power Morcellators have resulted in the spread of cancer and the death of female patients. Until now, this burden has fallen on the patient to report.

 “Nancy’s condition was not rare and her story could have very well been the story of a woman in my own family,” said Rep. Zinke. “Personal care, rather than ‘what’s good for most is good for all,’ is where health care needs to go. The device used in Nancy’s case was determined to be so dangerous that it’s no longer even made by one of the largest manufacturers. Requiring physicians and medical offices to report dangerous devices to the FDA and the manufacturer will save lives and I am proud to support this legislation. This bill will save lives. I hope to see it picked up quickly in the Senate.”

“It has taken too long to discover that what happened to Nancy is not all that rare; one out of every 350 women has this happen to them,” said Ray Curtis, widower of Nancy Curtis.“The Guardians Act will remedy this tragedy and protect unsuspecting patients from irreparable harm. Rep. Zinke is taking the lead and cosponsoring The Guardians Act; because he does not want one more woman to go through what Nancy and our family have.”

Full Statement from Ray Curtis:

“In September, 2013 Nancy Curtis, a wife, mother, daughter, and gifted teacher from Missoula, Montana, had robotic surgery to remove her fibroids. The idea was to use a procedure, rather than the traditional incision that required weeks of recovery time, that would get her back on her feet in no time. But, four days after the procedure, the doctor was told the material that was morcellated and suctioned out was cancerous (eight days after that he told her).  A subsequent CT scan showed that the cancer had been “upstaged” throughout her torso. There would be no recovery time for Nancy. Nancy discovered that she had about a 15% chance of living five more years.

“She was a determined fighter but, this past October, the cancer spread to her brain and in December, 2015 she died. She didn’t need to. This “quick and simple” procedure carried with it risk that she was completely unaware of. We now know Nancy could have opted to spend a few more weeks recovering from the surgery rather than two years of chemo, radiation, scans, fear, and, finally, death. This story does not have to be repeated.

“It has taken too long to discover that what happened to Nancy is not all that rare; one out of every 350 women has this happen to them. That is one too many. One of the basic tenets of American society is that every individual life matters. It seems people did know about the risk. Since her surgery the FDA has finally taken some action and Johnson and Johnson has stopped selling their morcellators. Now Congress is taking action. The Guardians Act will remedy this tragedy and protect unsuspecting patients from irreparable harm. Rep. Zinke is taking the lead and cosponsoring The Guardians Act; because he does not want one more woman to go through what Nancy and our family have.”