Spinal implants, like those manufactured by Boston Scientific Corp., Medtronic and St. Jude Medical Inc., are geared toward helping patients cope with chronic back pain or nerve damage.
But a recent Wall Street Journal report reveals that in far too many cases, patients are emerging from the procedure unable to feel at all. Some suffer from partial paralysis. Others have reported experiencing progressive quadriparesis, which is a gradual weakening of each of the four limbs. Other patients report total paraplegia, and are now confined to a wheelchair.
Boston product liability attorneys know that while manufacturers are staunchly defending these devices, pointing to the fact that some 50,000 spinal implants are conducted annually, no one is eager to slow down and reevaluate the safety of a product that has become an increasingly lucrative aspect of these firms’ business.
The devices cost between $20,000 and $60,000 each, and global sales are estimated at $1.5 billion a year, divvied up primarily among the three aforementioned companies.
They work like this:
- A small external remote is used to signal a pulse generator that is implanted in the lower back.
- That pulsing sends currents of electricity through a series of extension wires that are tunneled through the spine.
- The electric current from those leads results in a tingling sensation that is supposed to mask those pain signals before they can make their way to the brain, allowing the person’s perception of pain to subside.
Patients report that if and when it works the way it’s supposed to, it’s a remarkable technology advancement that has provided them with the ability to ease themselves off powerful and debilitating painkillers.
But according to a number of recent lawsuits, the problem is that the surgeons performing the procedure aren’t adequately trained. The surgery seems fairly simple, but because of the extreme risk of that comes with any work done on the spine, the stakes are especially high.
Part of the issue is that doctors from many different disciplines are performing the procedure. Usually, there is a singular medical specialty group that handles these surgeries, and then authorities within those disciplines establish regulatory guidelines. But that isn’t happening here because the surgery is conducted not just by neurosurgeons, but by orthopedic surgeons, anesthesiologists and physicians specializing in pain management. Training doesn’t always include hands-on instruction.
The devicemakers do offer weekend training courses on the procedure, but at least one doctor familiar with the procedure went on record to tell the WSJ that the training isn’t adequate.
Some of the patients who have been left paralyzed said they never had any idea the risk was so serious, or that they might never walk away from surgery.
Earlier this year, researchers at Duke University reviewed some 12,300 spinal implant patient records, finding that roughly 100 experienced some degree of nerve-root or spinal-cord damage.
If you are the victim of Massachusetts product liability, call Jeffrey Glassman Injury Lawyers for a free and confidential appointment — (617) 777-7777.
When Spine Implants Cause Paralysis, Who Is to Blame? April 15, 2014, By Joseph Walker, The Wall Street Journal
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TVM Company Facing Falling Revenues & Legal Trouble, March 13, 2014, Boston Product Liability Lawyer Blog