The Birth of the Medical Device Guardians Act
The act was inspired by Dr. Amy Reed, a mother of six whose cancer was spread by a device called a power morcellator. Reed’s doctor used the morcellator during laparoscopic surgery to treat uterine fibroids, which are noncancerous growths.
Powerful surgical devices, known as laparoscopic power morcellators, grind up and spread undetectable uterine cancer cells like deadly shrapnel. Many women treated with these devices have faced severe side effects, and even death, since the FDA approved morcellators in 1991.
The agency was aware of morcellators’ risks at the time of approval, an investigation recently revealed.
Reed, however, was unaware of the dangers of morcellators at the time of her procedure. The device spread undiagnosed cancer cells in her uterus, taking her Stage 1 cancer immediately to Stage 4, per a statement from Mike Fitzpatrick, a Republican congressman from Pennsylvania who introduced the Guardians Act legislation.
Why the Medical Device Guardians Act Aims to Increase Patient Safety
Reed, who lived in Fitzpatrick’s district, died two years ago at age 44. Congressman Fitzpatrick introduced the legislation to protect patients like her.
“Underreporting of faulty medical devices has contributed to the harm or death of Americans across the country and we must ensure those on the front lines take the steps necessary to save lives, which is what the Medical Device Guardians Act does," he said.
Under the act, doctors who report unsafe medical devices to the FDA would be protected from a civil lawsuit — with the idea being to break down any barriers that might prevent them from making reports.
Congressional co-sponsors include Connecticut Democrat Rosa DeLauro, Illinois Democrat Jan Schakowsky and Texas Democrat Lloyd Doggett.
Doggett said the bill is necessary to end the medical industry’s existing “see something, say nothing system.”
“Far too often, this industry has put profits over people with insufficient testing of its products and cover-up of hazards,” he noted in a prepared statement.
The United States is the world’s largest medical device market, with global sales expected to soar to $800 billion by 2030, per NASDAQ. Device-makers chief regulator in the U.S. is the FDA.
Did the FDA Know the Risks of Morcellators?
The FDA knew laparoscopic power morcellators could spread cancerous tissue when the agency approved the first such device in 1991, as a scathing commentary in the Journal of the American Medical Association (JAMA) noted.
An extensive report released in 2017 following an investigation by the U.S. General Accountability Office found FDA officials knew morcellators could spread cancer — before Reed went public about the risks. Reed, who was the first patient to make an adverse event report to the FDA about power morcellators, was unaware of the health risks before her surgery.
At the time the FDA approved the device, regulators said it was highly unlikely that a woman undergoing a morcellator procedure would also have undiagnosed uterine sarcoma. They put the odds of this happening at 1 in 1,000 women to 1 in 10, 000 women.
The FDA defines uterine sarcoma as a type of cancer that's more common in women undergoing surgery for uterine fibroids. Uterine sarcomas and uterine fibroids look nearly identical, and today’s tests cannot distinguish between the two without surgery.
But the GAO report contradicted FDA officials’ statements, chronicling around 30 research papers published between 1980 and 2012 — prior to Reed’s case — that mentioned or concluded the risk of tissue dissemination with power morcellators.
For example, a paper published in 2012 reviewed 1,091 instances of uterine morcellation at one hospital. The paper’s authors concluded that the rate of unsuspected cancer after the procedure was nine times higher than what patients were being told. The authors warned of the risks of spreading hidden cancer with uterine morcellation.
‘May Spread Cancer’
The FDA has since raised the cancer risk of power morcellators to between one in 225 and one in 580 women. The agency issued a black box warning on the device in late 2014, warning “the use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients.”
Amanda Rusmisell, legislative liaison with the advocacy group Medical Device Problems, told MedTruth the Guardians Act is intended to protect consumers from the dangers of unsafe medical devices by requiring additional reporting of adverse events.
With doctors on the frontlines of medicine, Rusmisell said they’re ideally positioned to make reports to the FDA when they see problems in their patients.
“Like with Essure, if they put it in a woman, and it migrates to her spine...they can file an adverse event,” she explained, referring to the contraceptive device linked to more than 10,000 complaints. “That is the goal — that is how the system is supposed to work.”
Rusmisell said the Guardians Act is now seeking additional co-sponsors.
Responding to a report of the dangers of power morcellators, an FDA spokesperson acknowledged lapses in how the agency monitors the safety of medical devices.
“The FDA has noted the shortcomings of the current passive postmarket surveillance system and has been taking steps to establish a better system to evaluate device performance in clinical practice,” a spokesperson told JAMA.
Meanwhile, another patient protection bill, the Medical Device Safety Act is also working its way through Congress. The legislation would restore a patient's right to litigation if they are harmed by a medical device.
Right now, a 2008 Supreme Court decision, Riegel v. Medtronic, makes it nearly impossible to sue over a device-related injury or death.