Johnson & Johnson was the first company to produce an artificial spinal disc in the U.S. to potentially alleviate persistent back pain and permit natural body movement. The little device is named Charite and costs $11,500 with an additional $50,000 for the implantation surgery.
Recently there has been debate about the durability of the device. Surgeons predict that over the next 10 to 15 years there will be a wave of patients who will suffer complications and require a more dangerous surgical removal of the device.
One major concern is that the clinical trial used to obtain FDA approval was only 2 years in length; a length far too short for a device that is expected to remain in the spine indefinitely without becoming displaced or causing other problems. The clinical trial also only involved 304 patients. Complications that may occur with the disc replacement surgery include blood transfusion, death, paralysis, or the need for additional surgery.
Many patients are finding that they actually have equal or even more backpain, after the Charité spinal disc was implanted. Some patients also accuse Johnson & Johnson of failing to warn them that the success rate of the disc implant operation is only 57%.
It is also alleged that Johnson & Johnson did not reveal that their clinical trial of the Charité disc replacement only met with moderate success, and did not include pain relief in their measure of success, nor did it include restoration of natural motion - in spite of their slogan that says 'Natural motion is back.'™.
Charite Spinal Disc Articles
Investigations Focus on Illegal Marketing by Medical Device and Supply Companies
Government law enforcement agencies have made it known that illegal marketing and promotional practices of medical device and supply companies are now the targets of investigations basically because lawmakers who oversee spending by public health care programs say the booming business in this field of medicine is a little too good to be true.
No Preemption For J&J Against Charite Spine Surgery Victims
According to Johnson and Johnson's SEC filings, as of December 31, 2006, there were 100 lawsuits pending against the company involving the Charite artificial spinal disc, seeking "substantial compensatory and, where available, punitive damages."
Medical Devices - April 2007 Litigation Update Part I
The Charite artificial spinal replacement disc, manufactured by DePuy Spine, a Johnson & Johnson subsidiary, was approved for sale in the US in October 2004, as an alternative to spinal fusion surgery for specific types of patients. Yet as soon it was approved, doctors immediately started implanting the device off-label for unapproved conditions and within 2 years the FDA had received over 130 reports of serious adverse events.
Charite Spinal Discs: Approved Despite Evidence of Complications
J&J's Charite Spinal Disc Bonanza Short Lived
Spine Surgery Performed Much Too Often
Injured Charite Spine Victims and DOJ go after Johnson & Johnson
Lawsuits Multiply for Johnson & Johnson's Charite Spine Disc
No Midicaid for Charite Artificial Spinal Disc
Charite Spinal Disc In the News
SEP-10-06: More than 350
Charite disc reciprients claim the disc is defective. [
OPED NEWS: CHARITE DISC]
AUG-01-06: Poor results in some patients spark lawsuits against
Charite disc replacement. [
CLARION LEDGER]
JUL-23-06: More than 200 people are seeking redress regarding complications from the
Charite disc implant. [
USA TODAY]
APR-14-06: Doctors disagree on viability of
Charite spinal disc implants. [
OC REGISTER]
OCT-20-05: Class action filed claiming
Charite spinal discs are subject to failure. [
HEALTHPOINT CAPITAL]
JUN-14-04: FDA approves
Charite spinal disc implant after only one clinical trial. [
HEALTHPOINT CAPITAL]
Register your Charite Spinal Disc Implant Case
If you or a loved one has suffered from increased back pain after having a Charite disc implanted, please click the link below to send your complaint to a lawyer for a free case evaluation.
