After Dermot Roche was diagnosed with osteoarthritis, his doctor said he needed a new right hip, but the metal-on-metal hip his doctor implanted provided no relief.
Instead, his hip became red, swollen and “incredibly painful,” Roche told MedTruth. He began relying on painkillers to get through the day.
Years passed, and the hip “never really got better,” Roche, now 39, recalled.
So he wasn’t surprised around three years later when he turned on the TV and saw news of a recall on the DePuy Orthopaedics ASR implant that had brought him so much pain.
“I was thinking, ok, I’m not crazy. This is actually a real problem,” Roche said.
The unfortunate reality is many patients learn their implants could be harming them through the news, said Jeremy Elias, founder and CEO of TrackMy™ Solutions. It’s a problem that TrackMy, a novel application connecting patients’ medical devices to valuable safety information, aims to solve. Customers who sign up are alerted when recalls and adverse events occur with their devices.
Although the U.S. Food and Drug Administration (FDA) requires device makers to adopt what’s known as a device recall strategy, recall notices rarely trickle down to patients. The FDA regularly sends out advisories about device-related problems, but few patients know the brand name of their device or other key details that would allow them to recognize the warning may apply to them.
Doctors tend to “dumb down” information they tell patients, explained Angie Firmalino, who last year launched the patient advocacy website Medical Device Problems after suffering years of health problems related to the birth control implant Essure.
She added, “It’s been hard for people to even find out what they have implanted in their body right now. There’s no uniform way for patients to have this information.”
That’s where TrackMy comes in. The application monitors recalls and product issues with software connecting to medical records in a growing number of hospitals and doctor’s offices. Patients put their own data into their device, and the app informs of them of medical device updates that would directly impact them.
“Think of TrackMy as an implant registry. Any patient who goes in and has an implantable procedure should know about TrackMy,” said Elias.
While patient medical records provide important details surrounding a patient's medical device, the records are not set up to flag product safety issues so that the doctor can warn the patient.
“The reality is there’s no infrastructure for doctors to notify patients,” Elias explains. “Doctors at a disadvantage because they don’t know which patients have which device. Electronic medical records have this information, but it’s just sitting there."
Warning patients about recalls and adverse events is increasingly critical as growing numbers of patients report being sickened and harmed by medical devices. An estimated 2,500 device recalls occurred in 2018 alone.
Although the FDA is charged with protecting Americans from unsafe medical devices, a regulatory loophole allows the vast majority of medical devices to easily win market approval, noted former FDA commissioner David Kessler. Through a process called 510(k) clearance, device-makers must only demonstrate their new device is substantially equivalent to one already on the market.
In addition, new medical devices are subject to looser safety standards than new drugs. New devices need only show a “reasonable assurance” of safety to be implanted in patients. In contrast, drug makers must show “substantial evidence” of a new product’s safety and effectiveness — a more rigorous standard typically requiring three randomized, controlled studies in patients.
The lopsided system means FDA device approvals far outpace its watchdog actions.
“In 2017, the FDA approved more than three times as many devices as it did in 2010, while its warnings to device manufacturers about product safety fell by nearly 80 percent,” according to a recent investigation by news outlets including NBC News and Associated Press, and led by the International Consortium of Investigative Journalists (ICIJ).
Last week, a disturbing new investigation by Kaiser Health News showed the FDA has allowed medical device companies to file reports of injuries and malfunctions in a secret database, leaving patients and doctors in the dark. Meanwhile, the FDA continues greenlighting medical devices at a rapid pace, approving a dozen new or modified medical devices with unknown side effects every single business day .
“The patients become the guinea pigs and it’s not until 10 to 20 years later that is pulled from the market, and by that time tens of thousand of people could have cancer, injuries and deaths,” noted Firmalino, a patient advocate.
Still, there are signs of progress at the nation’s device safety watchdog. The FDA claims they're rolling out a program to track medical devices via a unique device identifier, or UDI.
This week, the FDA put out a statement announcing their launch into investigations of inflammatory and immune responses in patients from breast implants, Essure and metal-on-metal hip implants. The news represents a significant shift for the regulator, which had disputed new evidence of breast implant-related illnesses.
The FDA acknowledged patients had experienced “fatigue, rash, joint and muscle pain or weakness” due to breast implants, and noted, “we believe the current evidence, although limited, suggests some individuals may be predisposed to develop an immune/inflammatory reaction when exposed to select materials.”
As for Roche, he said his DePuy ASR hip implant was finally replaced in 2011. Like the vast majority of medical devices, the metal-on-metal hip had never been tested in humans before it was implanted in thousands of people worldwide, as ICIJ reported.
Following a surge of patient reports of metal ion poisoning related to ASR hip implants, DePuy announced a worldwide recall of 93,000 hip implant devices in 2010. The company, a unit of Johnson & Johnson, acknowledged 12 percent of the implants failed within five years, requiring costly and painful removal surgery. Johnson & Johnson has since settled thousands of patient lawsuits, and recently agreed to pay $120 million to resolve deceptive marketing claims brought by attorneys general in 46 states, as reported by Reuters.
Today, Roche suffers from rheumatoid arthritis and a painful back condition called ankylosing spondylitis. Once a professional medical photographer, he said constant pain has left him unable to work full time. It’s also taken a toll on his emotional well-being.
“You feel useless, depressed,” he acknowledged. “You feel like a failure.”
Now outfitted with a new hip, Roche signed up for TrackMy after hearing about the service in a Facebook group.
Many patients fare worse than Roche. Worldwide, 83,000 patients have been killed by the very medical devices that were supposed to help them, reporting by the ICIJ found.
Indeed, a defective pacemaker was the catalyst for TrackMy, said Elias. The pacemaker had been implanted in his best friend’s grandfather, who died after the device stopped working.
“That was the accelerator that started to make this real. It was preventable,” Elias said of the death. “If we would’ve known the device had been recalled, he could still be here today.”
Learn more about the TrackMy app to stay up to date on medical devices.