Brookfield, WI, July 29, 2015 --(PR.com
)-- Darcy Eisenman has had her share of troubles with medical implants. She’s had numerous failed surgeries, a recalled bone growth stimulator, prolonged disability, unbearable pain and numerous complications.
Recently, Darcy received a “bad news” letter from the hospital about the medical devices her spine surgeon implanted. The letter said that the devices implanted into her back may be counterfeit. In order to determine the authenticity of her implants, another surgery would be needed to remove and inspect the medical implants.
“That surgery would have been sooner rather than later,” Darcy said “because a screw has since backed out and is resting on a nerve, causing me terrible pain.” Further, she said “I can’t find a surgeon to operate on me because of the complications caused by all of my failed surgeries.”
At the head of the controversy is a Wisconsin neurosurgeon and a California implant company alleged to have produced knockoff spinal screws and rods out of a non-medical grade machine shop.
The counterfeit parts were manufactured by a California machine and tool shop and sold by Spinal Solutions LLC, the suit charges. Findings of the Counterfeit Spinal Implants included:
-The implants were made of low-grade material and were not made with the original high-grade titanium materials
-Counterfeit screws had uneven threads and a much higher risk of backing out or breaking.
-Some doctors who used the fake hardware took kickbacks including cash and private plane rides
-Middlemen profited by wildly inflating the cost of the screws, according to one suit filed in Sacramento, CA.
-A hospital executive pleaded guilty in April to paying doctors to bring in patients as part of a $500 million insurance scam.
-Spinal Solutions executive admitted to bribing a former California State Senator to keep huge insurance payments flowing.
Counterfeit medical devices and recalled medical implants pose a real threat to patient health and are emerging more and more in the $110 billion per year market. Counterfeit and recalled implants may cause infection, injury, produce fallacious test results, and possibly death.
The World Health Organization (WHO) warns that 8% of the medical devices in use are counterfeit, creating a branch to protect the public from such devices called the International Medical Products Anti-Counterfeiting Taskforce (IMPACT).
Recalls cost the medical device industry on average $2.5 – $5 billion per year according to a McKinsey & Company study.
Thousands of patients, many of which may never be identified due to human data entry and retrieval errors, have defective devices implanted.
Many of these devices cause pain and medical complications, with their recipients unaware their medical implant is fake or have been recalled.
One counterfeit implant example was the 2010 Class I recall of counterfeit surgical mesh. Surgical meshes of this kind are used to reinforce soft tissue where weakness exists, such as in the repair of hernias and chest wall defects. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death. Although marketed in the United States labeled with the C. R. Bard/Davol brand name, these meshes were NOT Bard-manufactured products.
On July 6, 2012, one of the world’s largest manufacturers of medical equipment and orthopaedic devices, recalled two of its artificial hip implant systems. They recently agreed to a $1.4 billion dollar settlement surrounding their defective hip implants systems. Some of the complications of the defective hip implants included:
-Fretting and corrosion in and around the modular neck junction can release excessive metal debris into the surrounding tissue.
-Metal ions in surrounding tissues can result in inflammation leading to an immunological response including metallosis (metal poisoning), necrosis (tissue and bone death) and pain requiring revision surgery.
-Excessive metal debris in the joint space can lead to osteolysis, also known as bone loss, and may require revision surgery.
Implant Pedigree: Because there is no fool-proof way to track an implant’s pedigree today, it’s relatively easy for a device to be counterfeited and enter into a hospital’s inventory. Unscrupulous acts like those alleged by Spinal Solutions may simply switch the FDA approved implant with the counterfeit implant. Others sell replica parts, often made in China, to unknowing hospitals that end up in hot water when revealed – similar to the C. R. Bard/Davol counterfeit surgical mesh. An internet search for Chinese implants yields thousands of results – from dental implants to pacemakers. They even list the original manufacturer product and trade name such as “Hoffmann External Fixation Small Fragment Set Stryker Surgical Instruments Orthopedic Trauma” on their products. This makes it virtually impossible for a hospital to know with absolute certainty that the device is the FDA approved version rather than a fake. When it all unravels, often, the hospital is dragged into court.
Surgical devices are implanted in a sterile environment. In certain cases, hundreds of implants are brought into the operating room in countless set configurations. Keeping track of which devices were implanted and which were not with absolute accuracy has been impossible to accomplish. Many of these devices are small and identical in shape. They are typically brought in by outside manufacturer representatives or are re-sterilized from another case, if previously unused.
Nurses use several methods to try to keep precise implant records, including clip boards, stickers, calling out numbers, relying upon a manufacturer’s representative to provide accurate information and other manual methods, such as trying to piece it all together after the surgery. All of these methods, however, are highly inaccurate. At the end of the surgery, chances are that at least some of the implants have been misidentified.
Hospitals may be paying as much as 30% or more, because of inaccurate implant counts, unnecessary upcharges by reps, who charge hospitals; the hospitals in turn, unknowingly charge patients and insurance companies for these devices. A recent example of overbilling involves former regional manager and a former sales representative who admitted to rigging more than $800,000 in overcharges to hospitals and surgery centers by misrepresenting their use of the company's orthopedic products, U.S. Attorney Paul Fishman said. In another example, a sales representative with the publicly traded medical device company overcharged medical facilities by billing them for a greater number of products than they actually used or for more expensive products, which would bump up his own compensation, prosecutors said.
The American Legion believes that VA still has a problem tracking surgical implants, and until it is fixed veterans remain at risk. An audit made by VA’s Office of Inspector general two years ago identified expired surgical devices on VA supply shelves. The Government Accountability Office has also indicated that VA has an inaccurate tracking capability in recording the serial numbers of implant surgical devices.
A January 13th, 2015 GAO report found that the VHA was limited in its ability to identify and locate patients who had received surgical implants, which, according to the GAO, "has potentially significant patient safety and cost implications." The report also found VA surgical implant vendors are getting involved in patient care, which goes against industry practices, according to medical experts.
Government Action: The FDA UDI Final Rule. In an effort to combat counterfeit medical implants and improve recall efficiencies, the FDA is now implementing regulations that would place requirements on manufacturers so that legitimate products may be traced by marking unique device identifiers (UDI) on each of the products.
“The new law is the first step to reduce counterfeit devices and facilitate quick recall alerts,” said Pat Cairns, Matrix IT’s Vice President. “However, it will take a collaborative effort from all stakeholders to ensure patients are receiving authentic and proven medical implants.” Cairns said, “even though medical implants will eventually be marked, eliminating the human element of data entry is imperative to successfully protecting patients with medical implants.”
Private Sector Innovation: Technology has emerged that takes the guesswork out of implant tracking. Matrix IT Medical Tracking Systems, Inc., based out of Wisconsin, has created TRACTUS, a high speed scanner that is used in the sterile field to track the implant’s unique device identifier (UDI) information, including: Manufacturer, device, lot, serial and expiration. The scanner works real time during surgery and accurately identifies each implant as well as placement of the implant in the patient.
The surgeon scans the implant, and then identifies the implant’s placement inside of the patient. Because the sterile-covered scanner is placed next to the patient during surgery, each implant is identified on an “as you go” basis.
Surgery time is reduced because hospital staff don’t need to pause during surgery to record implant information, which saves money and is safer for patients.
After surgery, hospital departments such as central supply, sterile processing, patient financial services and medical records must each manually input this information into their computers. With TRACTUS, the data is electronically sent to the corresponding departments, saving the hospital labor costs.
Coupled with UDI tracking software that documents every implant from the manufacturer to the hospital, TRACTUS verifies that each device is FDA approved before it is implanted and provides the hospital with instant results of the implanted devices. In the event of a recall, the hospital may instantly alert affected patients.
TRACTUS also provides accurate implant utilization information so that the hospital may accurately charge for their services as well as verify manufacturer charges for implants used during surgery.
TRACTUS offers utilization data that may be parsed such as a comparison of surgeons and how long a particular device takes to be implanted, cost by surgeon or procedure, as well as many other capabilities.
Future capabilities will allow the study of long term patient outcomes, providing important information on how each device and surgeon performs in multiple categories, including age groups, gender or diagnosis.
“TRACTUS will soon be available to implant manufacturers so that they may test each implant before they are distributed,” said Cairns. “Hospitals will be able to install the scanners in each of their operating rooms to track which patients received implants and identify the implant locations.”
Inventor of the sterile field tracking technology, spine surgeon Branko Prpa, M.D. said “because Tractus is the final portion of the implant chain of custody, healthcare organizations may guard against counterfeit implants and quickly alert patients with recalled implanted devices.”
"I wish that Tractus was available a long time ago," said Darcy. “I would have been alerted right away when my Bone Graft implant was recalled, rather than years later.” Darcy further stated, “Also, I would have avoided a failed surgery by catching the fake Spinal Solutions hardware before they ever implanted them in patients.” “There is not much I can do now,” Darcy said. “I just want to help make sure no one else has to endure what I went through.”
For more information on TRACTUS and Matrix Medical, their website is available at www.matrixmedical.co/