British athlete Dai Greene made a fateful decision in the spring of 2013. He had hip surgery that involved the insertion of a The Medicines and Healthcare products Regulatory Agency (MHRA) cleared surgical mesh to repair a minor hernia. What happened next seems almost incomprehensible. Greene, a world champion hurdler who captained the Great Britain athletics team at the 2012 London Olympics, lost five years of his career after the surgery, which he was told would allow him to return to the track within weeks.

What happened? The mesh Britain’s MHRA okayed failed miserably, causing gross complications and injury in Patients, like Greene who had this mesh implanted in their bodies. And this mesh continued to be surgically implanted despite these serious post-op problems.

But thank goodness that could never happen in the United States, right? Wrong. In this country, there are a variety of classifications the FDA assigns to medical devices to be implanted in the human body, including FDA Approved and FDA Cleared. For most people these terms seem interchangeable, but they are as different as leather and faux leather.

Cleared Vs. Approved

On an episode of HBO’s “Last Week Tonight,” host and funnyman John Oliver gave a sobering assessment of the $156 billion medical device market, and he did not paint a funny or pretty picture.

He pointed out that about 32 million Americans, or one in 10, have some medical device in their bodies. What could possibly go wrong? Turns out, plenty. Oliver explained that each year medical devices are related to 80,000 death and 1.7 injuries. And a contributing factor to these deaths and injuries, arguably, are the way these devices are classified by the FDA.

According to Oliver, the phrase “FDA Cleared” doesn’t really mean anything. “Like when a cereal says it’s part of a complete breakfast,” he said. “Anything can technically be part of a complete breakfast. If you ingest it alongside oatmeal, granola, yogurt, and a glass of orange juice, heroin can be part of a complete breakfast.”

FDA Approved means that the device has been tested and shown to be safe and effective in clinical trials. No such clinical trials are required for FDA clearance. Instead, FDA Cleared products earn their designation by piggy-backing their assertions by citing previous clinical trials for previous similar FDA Approved devices and avoid having to test this new device in human subjects to prove their efficacy and safety before mass marketing them. Most products are accepted through a FDA 510(K) application for premarketing and clearance. Shockingly, 80% of FDA “cleared” medical devices move on via this pathway. So, when things go wrong with these “substantially similar” devices because of the material used (metal hip replacements) or product repurposing (hernia mesh used for vaginal issues) the results are widespread and catastrophic.

And that’s when class action suits are born, putting well-meaning Physicians in the crosshairs. What most people don’t realize is that the choice of what medical device is implanted in a Patient is not normally left up to the Doctor. Medical device makers deal directly with hospitals—often wining and dining them and offering buyers incentives to secure them as exclusive clients.

What Could Go Wrong

In Greene’s case, he was unaware of the dangers he was facing as indicated in the online diary entry he wrote for the IAAF International Association of Athletics Federations:

“Since my last IAAF diary piece some of you may be aware, I had to undergo a hernia operation in March. It came on pretty quickly. I had enjoyed a good indoor season, breaking the British record for 600m, but started to suffer some soreness in the hip. I was given the choice that I could either delay an operation until the end of the season or have it done there and then. I decided to have the operation done straight away. For me the decision was a no-brainer.”

But even in his optimistic diary entry there were hints that something was already going wrong with his recovery. He also noted, “Fortunately, within nine days of the surgery I was working on the anti-gravity treadmill and I was back running again within two weeks. I can now do everything I need to in training, although some scar tissue has slightly held me back. There is a bit of a drop off in training whereby I can’t prolong every session in the way I would like.”

According to the British newspaper, The Guardian, Greene began to experience acute pain not that long after the surgery in 2013. A series of problems to resolve the issue revealed that the implanted mesh became “frayed” and “entangled with nerves in his pelvis.”

Greene told The Guardian, “That’s why anytime I was moving I was in loads of pain, because there was something just constantly pressing on my nerve.” What followed were multiple surgeries, putting his sports career on hold and forfeiting money-making sponsorship contracts. Losing five years of competing is devastating for athletes, who have a short window of opportunity to participate in their sports. “To have that much time off in your career, of no running, is just crazy,” he said. “From being one of the best in the world year after year to just falling off the radar entirely … It’s a massive frustration. I’ve only got a finite amount of time to do what I want to do in my career. I try not to think too much about [what happened] because then I’ll get bitter.” Greene told The Guardian, “The golden thing I got sold was that after three weeks you’ll be back running and after six weeks you’ll be completely fine. It got advertised to me as foolproof … stronger than anything else you could have.”

Greene’s story is all too common. Take the case of metal hip replacements. This FDA Cleared derivative of the nonmetallic design, degraded because their parts were grinding metal upon metal. It is a classic case of how using a basic design with new material without proper testing can be disastrous.  The pain inflicted on the Patient and the necessity of having to remove the implant and replace it with a nonmetal unit has inflamed Patients, who blame their pain and suffered on their caregiver. A few nights after John Oliver’s expose, I met an old friend who had just had a metal hip joint removed and replaced. He was angry and bitter and felt that he was used as a guinea pig in this process. And although he knew the replacement manufacturer was at fault, he also blamed his Physician. “He should have known better,” he said. “He should have taken better care of me.” It’s hard to argue this point with a man who still walked with a cane, was still in pain and felt violated.

The only consolation for him was that at least his hip replacement could be removed and replaced. The news isn’t as good for surgical mesh. In Greene’s case, the mesh is made to integrate itself into human tissue, which grows around it, sealing it into place. That makes it difficult to remove. For example, a mesh product made by Ethicon, a Johnson & Johnson subsidiary company, was recalled after it was shown to cause complications including infection, chronic pain, hernia recurrence, internal adhesion, perforation, intestinal blockage, revision surgery and even death.

Women have suffered similar reactions to transvaginal mesh (TVM). TVM is a net-like mesh reinforcement placed in a woman’s pelvic region for women who have been diagnosed with pelvic organ prolapse (POP) and stress urinary incontinence (SUI). However, TVM, which was also FDA Cleared based on its similarity to hernia mesh, was also recalled based on findings that TVM can cause serious problems like mesh erosion, organ perforation, serious infections, pain and scarring, as well as urinary incontinence. In addition, manufacturers have paid at least a billion to settle transvaginal mesh lawsuits from affected women.

Another example is Stryker Rejuvenate, ABG II and LFIT V40 hip implants. Stryker hip implants were constructed as a metal ball and socket (MOM). This implant was recalled when clinical studies indicated that MOM implant components are prone to friction during movement, which send off microscopic wear particles into the bloodstream and surrounding tissue. In addition, the failure rate for these devices is very high. One study in 2012 showed 90% of MOM hip implants failed within 3 years, that Patients have revision surgery. In 2014, Stryker put aside $1.4 billion to settle lawsuit claims over defective, now-recalled MOM implants.

Knowledge Equals Change

And for all the class action suits you see advertised on TV, however, Oliver claims we are only seeing the tip of the iceberg. He reported that about half of medical device failures aren’t reported to the FDA and often complaints aren’t taken seriously. He cited the example of breast implants. Women complained for years that breast implants had become painful and damaging. It was only when women took to social media and told their stories on Facebook that the FDA started paying attention and held public hearings on the issue.

Progress is there, but it is slow moving. Since the disaster of the metal on metal hip replacements, the FDA is requiring manufacturers to test these devices on human beings before being certified. The FDA has also ordered manufacturers to stop selling vaginal mesh. Small victories in a process that needs a major overhaul.

Greene believes that more has to be done to protect the consumer from the terrible dangers of ill-conceived and untested implanted medical devices. He expressed a real concern to The Guardian about how uninformed Patients are when facing surgery that requires a medical implant. He believes that more information should be available to Patients, so they can make an informed decision about their treatment.

Shouldn’t Patients know the pluses and minuses of using a particular device over another, for instance? Shouldn’t Patients be told upfront whether a device is FDA Approved or FDA Cleared? It would also be important to know the success and failure rate of these devices—not only in terms of “fixing” the problem, but how it affects the quality of life.

Greene also has concerns about a lack of information available to Patients regarding the pros and cons of surgery and implants. “In sport we always like to deal in numbers,” Greene told The Guardian, “It’s simply asking questions of people who’ve had surgery. I feel like there’s nothing out there that’s that easy to get hold of for us. We just take whatever information the doctor is telling us or selling us as fact.”

In this, as in most cases in life, knowledge is power. But in the case of your health, knowledge can save your life and quality of life. And knowledge can mobilize the public giving them the power to change the way medical devices move through the system of approval by the FDA, ensuring the safest options for Patients and their families.