The bottom line - medical devices are big business bringing over $100 billion-a-year to the industry, giving industry the muscle to get what it wants - products to market quickly and with the least cost.
Unlike the scrutiny drugs must undergo, when a medical device is fast-tracked onto the market without premarket review for safety, the public becomes the real-world clinical trial and we see the complications.
The fast-track process is called 510(k) and after a fee and an exchange of paperwork, the manufacturer must name a ‘predicate’ or a device already on the market that their new device resembles. The new device is okayed for marketing by the FDA. The Institute of Medicine last spring called the 510(k) process “fatally flawed” and recommended it be abolished, but the FDA did not adopt the recommendation of the IOM.
Most low, medium and some high-risk permanently implanted medical devices are put on the market through the 510(k) process.
In January, 31 mesh manufacturers received letters from the FDA requiring three years of post-implant surveillance to monitor the complication rate. This is after the device is already implanted in women. Background story is here.
It should come as no surprise then that transvaginal mesh, used in women, makes the Big Four.
ProPublica reports implantable surgical mesh is a reinforcement structure used to shore up organs that have prolapse through the vagina or to treat stress urinary incontinence.
Problems: First used in the 1990s to fix internal hernias, the invention of surgical mesh “kits” appear to have accelerated the rate of complications with the FDA noting in 2011 that the thousands of complications reported to the agency represented a five-fold increase in recent years and an average of 15 percent a year over the past decade. When the FDA reported that complications are not rare and that the benefits of using polypropylene mesh may not be worth the risks, lawsuits were filed by the hundreds against the four main manufacturers, Boston Scientific, Ethicon, C.R Bard and American Medical Systems.
The industry continues to report that mesh is safe and any problems are due to the training of implant surgeons.
As the Baby Boomer population ages, thousand of Americans are affected by advanced arthritis and broken hips and get a total hip replacement. Traditionally the implants contain a metal head that fits into a plastic cup. In 2005, Johnson & Johnson’s DePuy Orthopaedics introduced a metal-on-metal (MOM) hip claiming it was “substantially equivalent” to other artificial hips already being marketed. With the exception of the MOM hips that used a novel approach called “resurfacing,” metal hips went on the market after passing 510(k) scrutiny for substantial equivalence.
Problems: According to the British Hip Society, the DePuy had a failure rate of almost half of the patients who received implants within six years. Hips are designed to last about 15 before they need to be replaced but patients had metallic particles in the blood and surrounding tissue. Joint pain from metal caused thousands of complaints and lawsuits. The DePuy was recalled in 2010 based on new information the company said it received, but not before almost 100,000 patients had the DePuy hip implanted.
Heart valves or annuloplasty rings are a circular device that pinch together flaps of the heart valve to prevent blood from flowing back into the lungs or heart. Originally classified as high risk or Class III, they were supposed to go through premarket approval (PMA), a process that requires clinical studies to prove a device is safe before it makes it to the market. That all changed in 1997. After petition the government, the FDA agreed to lower the class risk to Class II or moderate-risk even though the rings were implanted putting it in a class with sutures and hearing aids.
That means if you seek a replacement heart valve, you can be sure the medical device has gone through rigorous FDA examination, not so for the rings which undergo 510(k) approval for sale. Advanced Medical Technology Association, AdvaMed, the aggressive industry trade group was behind the reclassification, reports a Chicago Tribune investigation.
Problem: Annuloplasty rings top Class II in the number of deaths. ProPublica reports manufacturer, Edwards Lifescience, didn’t even bother to go through the fast-track 510(k) clearance process, instead marketing the Myxo ring which was implanted in more than 100 people without any FDA clearance. The FDA let the company off the hook saying it made an “honest attempt” to interpret the regulations.
A defibrillator can be implanted in the chest of a cardiac patient to deliver life-sustaining shocks when it suspects heart failure. Leads connect the defibrillator to the heart and they are supposed to deliver the shock when needed, then shut off. However problems arose when faulty defibrillator leads fired unexpectedly or failed to fire when needed. The industry is a $10 billion dollar one that has had more than its share of failures and lawsuits.
Problems: The St. Jude’s Riata lead was recalled last year because of a potential to short circuit in the body or deliver a high voltage, but not before about 79,999 patients received the medical device. The group reports the maker knew about the problems for a full year before the recall. That led to an additional 20 deaths. The company says the device went in for a redesign and is conducting a study of the Riata lead.
Knowing there is a problem with medical devices and the people they harm, the FDA is considering an enhances premarket, postmarket and compliance plan, but that takes additional funding, a portion of which comes from the very medical device industries the FDA monitors.
CDRH 2012 strategy
Chicago Tribune -heart valve ring and AdvaMed petitioned the FDA to lower class