More Than 2 Million Dental Implant Injuries
Posted on Wednesday, July 10th, 2019
The hype about dental implants is nothing new to this blog, nor is what the hype covers up.
What is new is that the FDA has finally published it’s once-hidden database on injuries caused by medical devices, which underscores just how much these prosthetics have been oversold.
All told, the new report documents 5.7 million incidents involving all sorts of devices. Over two million of those involve dental implants – 117,200 serious injuries last year alone.
“A lot of people have gone out and gotten these and probably don’t know about these risks,” former FDA manager Madris Tomes recently told Kaiser Health News.
Why is this information only coming to light now? As Dr. Bicsupid reported,
Federal law requires manufacturers to file reports to the FDA when devices cause or may have caused a serious injury, defined as an injury that is life-threatening, results in irreversible impairment or damage, or necessitates medical or surgical intervention to prevent permanent impairment or damage.
The newly released reports were part of a program, known as alternative summary reporting, that allowed manufacturers of certain devices to submit quarterly summaries of serious injuries, as opposed to a report for each occurrence. Implant manufacturers who did not use this reporting method filed individual reports through a public database.
When the FDA formally ended this program on June 21, the previously undisclosed reports became public.
Most of the injuries – 57% – involved implants that failed to integrate with the bone into which they were placed. Another 28% involved loss of previous osseointegration.
“People who have metabolic conditions, people who have diabetes, people who smoke, people who are osteoporotic, they may have a lower success rate than a younger, healthy adult,” [Natalie Y. Wong, DDS, president of the American Academy of Implant Dentistry] said. “But on average, we do quote 90% to 95% success at 10 years.”
Yet research has shown those numbers to be considerably inflated and often based upon highly biased (or potentially biased) studies.
And this doesn’t even account for the fact that most reported injuries involve simple mechanical failure. Little consideration is given to their energetic impact on the body’s regulative systems, including the immune response. If that were taken into account, we suspect, the numbers would be even higher.
Just recently, Dr. V did a biofunctional resonance assessment on an implant one of his patients had expressed concern about. It had been placed in the socket of tooth #28, which is on the pancreas meridian.
“From an energetic perspective,” says Dr. V, “it took 7 vials of D# jaw osteitis to balance the meridian. That’s a tremendous disruption!”
When I measured the patient’s pancreatic meridian, I found both the exocrine and endocrine points to be mildly disturbed. The only item I tested it with was titanium, and sure enough, this balanced the meridian.
I was not testing it for all the metal specifically, but the titanium was disturbed, and it was disturbing of the pancreatic energetic system.
He adds that autoregulation fatigue around where an implant is placed may be another reason for the physical failure of so many implants.
While we don’t believe that implants, even “biocompatible” ceramic implants, are a good choice, we also believe that it’s up to each patient to make the choices that resonate with their health goals, needs, values, and desires. That requires having complete information and a clear view of the pros and cons of any treatment being considered or recommended.
When information like the injury data gets kept from the public, it makes it even harder to make an informed decision about implants.
We see that, too often, patients are given little more than a hard sell, with promises of a natural looking smile, sometimes provided in a single day, with no potential downside. They may never have had a real conversation at all with their dentist about the pros and cons of implants or factors that might not make them such a “good candidate” for the prosthetic.
We believe such conversations are necessary – about any treatment. The more you know, the better your decision-making can be.