PHOENIX (3TV/CBS 5) — Dental implants are marketed with the promise to change your smile and provide a new sense of self-confidence, but as implants surge in popularity, so do injuries. Last year alone, reports of problems with dental implants reached nearly a half million.
Any general dentist can place implants. However, there is no universal requirement that dental students have to perform a dental implant procedure as part of their training. Seeking additional training before performing the procedure on patients is optional and up to the discretion of the dentist.
Imagine a student driver passing an exam and being handed their driver’s license without being required to physically drive a car first. Reports of problems with dental implants passed 3.1 million over a 25-year period.
Recently though, a surge in those reports is raising the question of whether enough is being done to protect patients. Analyzing yearly data, there were less than 13,000 reports of problems in 2018. In 2021, reports skyrocketed to 477,823. More than 98% of the reports are categorized as injuries to the patients. The remaining reports fall under device malfunctions. The most frequently reported problem was implants failing to bond or losing the bond with the bone. When that happens, the implant is removed.
Reports of problems are found in an FDA database known as MAUDE, which stands for Manufacturer and User Facility Device Experience. The information in MAUDE is available to the public but difficult to access. The surge in reports may have continued to go unnoticed if it wasn’t for a former FDA employee.
Madris Kinard is the founder and CEO of Device Events, a company that specializes in searching the government database. In 2021 she discovered dental implants have more reports of problems than any other medical device. “These are catastrophic failures we’re seeing,” says Kinard.
The purpose of MAUDE is to monitor and track issues with medical devices. However, the reports are often incomplete and provide limited information. Kinard has studied the reports and points out, “What we fail to see is the outcome for the patients. What did the patient go through? Did they have to get multiple bone grafts to replace the bone? Did they lose the tooth and never have the ability to replace it?”
Dental implants are composed of three parts. The “implant” portion is a screw-like device drilled into the jawbone. A second piece, called an abutment, connects the implant to the replacement tooth or sets of teeth.
According to the FDA, the increase in reported problems with dental implants is associated with a surge in the popularity and availability of the medical devices. Advertisements for dental implants seem to be everywhere, touting individuals with beaming smiles who describe how dental implants improved their confidence, resulting in better personal lives and careers. What is not included in advertisements are warnings that failed implants can leave patients with pain, large dental bills and no teeth. A search of websites advertising implants shows average costs range from $3,000 for a single implant up to $90,000 for complete sets, making it a profitable procedure for the dental industry.
When contacted for this investigation, the American Dental Association pointed out that implant dentistry is not a specialty and can be performed by general dentists. The ADA stopped responding to questions about whether they would take action, after they were informed about the nearly half-million reports of problems last year.
The Commission on Dental Accreditation (CODA), which sets the guidelines for accredited dental schools, did not respond to multiple emails and messages. Of the more than 40 accredited dental schools contacted across the country for this investigation, several did not respond or declined to answer whether their curriculum included placing implants.
Roughly a half dozen responses pointed to the guidelines set by CODA. The guidance states that graduates must be competent in the scope of general dentistry, including the replacement of teeth. Those guidelines allow schools to define what that entails. One professor pointed out their standards require general dentists to be competent in the restoration of dental implants, not the surgical placement.
Dr. James Chaffin and Dr. Calvin Brown run CR Smiles Dental Center in Glendale, Arizona. Six years ago, the duo created the Simply Implants Institute, a program designed to train dentists on how to place implants. Over the four-day course, dentists complete multiple implants procedures under supervision. For some dentists, it’s their first time performing the procedure.
Dr. Chaffin believes when it comes to dental implants, most dentists do not have enough training. “I think half the implants I’m redoing are clinical errors,” says Dr. Chaffin. Dr. Chaffin calls “foundational issues” the most common problem he sees, explaining doctors don’t always take into consideration issues with the patient’s bite or the position of the jaw and muscles when placing implants. Other issues include using implants that are too big for the space in the bone, not using the proper number of implants to secure teeth and improper placement.
The doctors found a patient that epitomizes a number of those issues. The pair offered to help Ginger Peters after they saw her news story on a dental implant investigation on KPHO and KTVK in Phoenix. Ginger suffers from severe health issues that she says began when she got dental implants. According to Peters, 11 years ago, she went to the dentist for a single cavity. Instead, she was told she needed to have 22 teeth pulled. The dental bridge on her implants never fit properly, leaving her unable to chew food.
Reports of problems flew under the radar for decades, partly due to the fact the FDA had two separate systems for reporting problems.
The investigation from November 2021 focused on topics including possible contamination with dental implants and the fact that manufacturers do not have to reveal all the metals and materials used in their devices. Peters tested positive for a nickel allergy, but it is still not known if her implants contain nickel.
Dr. Brown brought Peters in for a CT scan after catching a quick glimpse of her dental X-ray on television. The more-detailed scan revealed several problems the doctors say they see routinely in patients suffering from issues with their implants. In addition to the implants being too large for her bone and angled improperly, the implants are not spaced properly across her jaw.
According to Dr. Brown, improperly-placed implants can lead to pain and bone loss. “It’s rubbing. It hurts. It’s like having a pebble in your shoe for 10 years. Your whole body is going to hurt,” described Dr. Brown.
A visual exam of Peters’ mouth reveals additional issues. The posts protruding from Peters’ gums are the wrong size and too small for her dental prosthetic to snap onto.
Cindy Cantarano worked as a dental assistant for more than four decades in various offices for general dentists, periodontists, endodontists, and oral surgeons. She says in her experience, specialists such as periodontists had higher success rates with dental implants than the general dentists she worked with, who would sometimes see as many as four out 10 implants fail.
Cantarano believes dentists don’t do enough to inform patients that their health problems could lead to problems with the implants. “I feel doctors need to express to patients that the implant may not last. The implant may not integrate well due to their health, diet, or smoking habits. Things like that can cause them to fail,” says Cantarano.
Studies show a wide range of factors can increase the odds of implants failing, including poor oral hygiene, bone quality, being over the age of 60, smoking, diabetes, chemotherapy, radiation and steroids. Other studies with extremely high success rates for implants that are sometimes used in advertisements do not reflect real-life success rates from private practices, partly because the studies include ideal candidates for implants and the clinicians running the trials are experts.
The success rate of implants cannot be calculated because the number of implants being placed each year is not tracked. The increasing number of injuries appears to be an indication of a growing problem.
The FDA acknowledges one of MAUDE’s shortcomings is that problems are underreported, meaning there are more injuries occurring than what is reflected in the current numbers. While the FDA regulates medical devices, the agency does not regulate health care or tell doctors what they can do within the scope of their practice.
With the revelation of the increasing injuries to patients, it is yet to be seen if the dental industry will take action. Again, the American Dental Association did not respond when asked for comment on the surge in reports of problems.
It also remains to be seen if doctors will fully inform their patients regarding the risks and increasing number of injuries, knowing that information could take a bite out of their profits. Contact investigative reporter Kris Pickel directly at [email protected]