Tim Anderson was driving home from a dinner celebrating his step-daughter’s birthday when suddenly, he blacked out. Despite the vehicle rolling over four times, he walked out of the hospital about 48 hours later, practically unscathed. The cause of the accident? The insulin pump he was using for his type 1 diabetes failed.
“The tubing got clogged,” Anderson recalls. “Usually it alerts me [if there’s a problem], but it did not alert me this time and basically I went into a diabetic coma while driving.”
Anderson, of Carson, Va., had to wear a neck brace for almost eight weeks following the 2010 incident, but otherwise has had no lasting effects. And although his pump failed — a risk when relying on a medical device — he says it’s a risk worth taking.
Anderson, now 41, was lucky. For thousands, the risk has resulted in deadly consequences.
Deaths and Injuries from Medical Devices
There’s no question, medical devices save lives. In addition, the lives of many more people are improved with implants of all types. Omar Ishrak, the CEO of the world’s biggest device maker, Medtronic, claims his company improves the lives of more than 70 million new patients each year.
But a worldwide investigation showed that medical devices were linked to 1.7 million injuries and nearly 83,000 deaths from 2008-17, according to a report by the International Consortium of Investigative Journalists (ICIJ) in 2018. In addition, the ICIJ said surgery to remove a defective or malfunctioning device led to almost 500,000 more incidents.
Among the most common medical devices to cause problems are artificial joints, stents, transvaginal mesh and defibrillators. According to the ICIJ study, about 32 million Americans have a medical device of some sort in their body, with people 65 and older making up the largest demographic. According to one study, there could be almost 1 billion people worldwide walking around with some such device in their body by 2030.
The Business of Medical Device Implants
As the number of people needing a medical device grows, so does the business of making the devices.
The ICIJ study showed industry sales went from about $118 billion in 2000 to about $400 billion last year. And a fund composed of leading medical device stocks posted a return of 125 percent in the past five years (as of Nov. 2018), compared to 52 percent for the broader economy reflected in the Standard & Poor’s 500.
The industry seems to know there are problems, because billions of dollars have been paid to patients. In just the past five years, according to the study, Johnson & Johnson has paid — either by agreement or court order — more than $4 billion to people in the United States who claim they were injured by defective hips, mesh and surgical staplers.
After Anderson’s pump was determined to be defective, he was sent a new device — the newest model — and hasn’t had any problems since.
He chose not to pursue any legal action, and the company didn’t put up a fight about giving him a new pump. “They never came out and said, ‘Yes, it was our fault,’” Anderson says, adding it was about time for his machine to be replaced anyway.
The FDA’s Role Regulation Medical Devices
One of the problems patients face is determining what caused a device to fail, and finding who is at fault isn’t always easy. The U.S. Food and Drug Administration (FDA) even admits it is difficult to determine when a problem leads to injury or death. Dr. Rudy Ochs, with Mercy Health Physicians Partners Hart Family Medicine in Michigan, said sometimes, particularly with joint replacement surgery, a patient might be a little too aggressive in their rehab, adding to the confusion of what is the cause of the problem.
“One of the things we encourage is first, patients (and) doctors, they can file what we call ‘adverse event’ reports through our program called MedWatch,” says Stephanie Caccomo, a press officer with the FDA. “You should also be notifying the manufacturer as well. That’s how we then investigate an issue. That’s how the manufacturer can investigate the issue.”
The FDA website — fda.gov — lists products that are subject to recall or are a safety concern. However, the list comes from news releases and other public notices, which not all manufacturers or companies provide. That is why it’s so important to file a report if you experience a problem. Another option is to sign up to receive notices from the FDA about recalls and problems with medical devices.
Just last year, the FDA announced it would begin reviewing regulations concerning the safety and effectiveness of medical devices, some of which don’t go through human testing before being used on patients. Modernizing the regulatory process would help keep pace with the increasing complexity of rapidly evolving technology, the FDA says.
Weighing the Risks
“Many of these devices are life-saving pieces, so there are benefits and risks,” says Caccomo, adding that a patient’s work starts the minute the doctor mentions the possibility of an implant.
“Make sure you understand what product your doctor wants to put in you, asking for information and patient brochures that go with the device,” she says. “The manufacturer has to disclose benefits and risks, and known complications.”
For Anderson, the risk of getting a medical implant was worth it. He prefers his insulin pump to when he had to give himself eight shots a day to fight his diabetes, which he has had since he was a child.
“The way I see the risk you take, it’s the same risk of walking out of your house and getting hit by a school bus,” Anderson says. “It’s very rare that it’s going to happen, but there’s always that possibility.”
But what if a device fails?
Contact your doctor. Or any doctor. Do your own research, like Hampton, Va., resident Sandi Dianna did — she turned to the Internet after having health issues after having reconstructive surgery following breast cancer, and found a community of people with breast implant illnesses.
“If they are comfortable with the original surgeon they saw, I’d send them back (to him or her) and have them evaluate the device,” Ochs says. “They’re usually pretty upfront with people and will say, ‘Yeah, we had a problem with it.’ ”
If you are not comfortable talking with your surgeon, find a doctor you can discuss the problem with, Ochs says.
No one knows your body better than you, and sometimes it’s hard to explain to a doctor what exactly is wrong. The more discussions you can have, even online, the better chance you have of finding a solution.
Implant Illness
How one woman figured out what was wrong
One aspect of medical device surgery that is sometimes overlooked is when the body rejects the new part or parts. That was the case for Sandi Dianna, who experienced numerous health problems after having reconstructive breast surgery following a bout with cancer.
“No one could figure out what was wrong,” says Dianna, an elementary school teacher from Hampton, Va. “No one even considered it could be the implants. I never considered it, never even thought that it would be a possibility because I thought they were safe.”
She and her doctors found no problems with the implants themselves. They didn’t break or leak. Still, for whatever reason, her body rejected them.
Dianna’s reconstructive surgery was in 2012, and her doctors had gone over the usual side effects. She was told that since her implants weren’t the liquid type (more like gummy bears, she said), there was nothing to leak out. Also that year, she had surgery to remove her ovaries and to implant a bladder sling. She experienced numerous problems in the ensuing years, but with all that was going on in her body, it was difficult for her and her doctors to pinpoint the cause or causes.
“I felt like I was dying and no one could figure out what was wrong,” she recalls. “I was so sick. I couldn’t even describe to the doctors how sick I was.”
After doing research online, Dianna learned there is an entire community of people who suffer from breast implant illnesses. While reading many of the symptoms these people were experiencing, she realized she had a number of them also. She immediately made an appointment with her plastic surgeon.
She remembers what she told him: “I am so sick, and the doctors can’t find anything that is wrong with me. The only thing I can think of is that it could possibly be the breast implants. At this point in time, I’m willing to do anything. (Just) get them out of me.”
According to Dianna, her plastic surgeon said she had a form of human adjuvant disease, which is when your body fights the foreign substance: “That was the first I’d ever heard that could be what was going on.”
She immediately scheduled surgery to have the implants removed. The day after the surgery, which was in July 2017, she started feeling better. She has continued to feel better ever since.
“I had immediate relief as soon as he took those implants out,” says Dianna, now 57. “I’ve had no problems since.”
