Wednesday, October 19, 2005

Failed Back Surgery

The New Jersey, USA Office of Bagolie Friedman Injury Lawyers has created the International Charite Artificial Disc Practice Group in response to the serious problems encountered by the recipients of the artificial replacement disc. The devise was recently approved for use in the United States despite failures throughout Europe and Australia.

Bagolie Friedman Injury Lawyers, with offices in Jersey City and Clifton New Jersey and Hollywood Florida, has begun to review and accept injury cases from surviving family members and individuals who have suffered serious complications after receiving the Charite artificial disc. "Our Charite Artificial Disc Practice Group is international in scope as the device has been used and failing around the world for nearly 20 years," said Ricky Bagolie, founding partner of the firm. "We will be reviewing potential cases from the United States, Australia and Europe," said Bagolie.

Johnson & Johnson became the first company in the US to receive approval for an artificial spinal replacement disc though it had been on the European market since 1987. The disc, approved by the FDA on October 26, 2004, is made of plastic and metal similar to the materials used in hip and knee replacements and is being marketed as an alternative to complex spinal fusion surgery. Currently, spinal fusion surgery, while reducing motion in patients, offers the only safe option for patients with chronic pain. Analysts believe the market for spinal discs could top $1 billion within a few years.

Johnson & Johnson's DuPuy Spine unit beat competitors to the US market by securing FDA approval of their device, but some orthopedic surgeons have strongly criticized the FDA for its approval of the Charite devices. They cite flaws in Johnson & Johnson's clinical study and over 17 years of evidence from Europe, where the devices have been in use for some time. They found the Charite artificial spinal discs have regularly failed in Europe, leaving patients with life-threatening complications.

"This is a technically demanding operation that very few, if any, surgeons are qualified to perform and the correct sizing and positioning of the device is critical for best functionality and lowest chance of failure," says Ricky Bagolie. The margin of error is so small and the chance of misplacement so great that these artificial disc replacements should be recalled to protect the public,” said Bagolie.

If these devices fail or when they wear out, the revision surgery may be extremely difficult and fraught with potential dangers of vascular, visceral or nerve injury and the risk compounds should they need to be removed. In addition to the potential complications associated with undergoing surgery and general anesthesia, the complications associated with artificial disc replacement may include: breakage of the metal plate, dislocation of the implant, splintering of the plastic and infection.

Bagolie Friedman believes there will be thousands of people in the USA, the UK,, Europe and Australia who suffer Charite artificial disc failure. "It appears from our initial investigation that Johnson and Johnson is responsible for manufacturing a medical device they knew or should have known was unreasonably dangerous in an attempt to capture some of the lucrative multi billion dollar back surgery market. They downplay the risks," Bagolie says. If you believe that you, or a member of your family, has been injured as a result of receiving the Charite artificial disc, contact Ricky Bagolie or Alan Friedman toll free at 1-866-333-3529, e-mail at visit now for a confidential and free consultation. ###