Defective Spinal Implants Recalled
The U.S. Food and Drug Administration has issued a Class I defective product recall for all lots of Synthes USA, Ti Syntex II Vertebral Body Replacement, a medical device used in a portion of the spinal cord to replace a collapsed, damaged or unstable part of the spine. The FDA has received reports of "moderate to severe loss of vertebral body replacement of height" caused by a failure of the central component. This failure is apparently occurring at six to 15 months after the device is implanted.
Serious Health Issues Linked To Product Defects
Potential adverse health issues involved with these medical device products include nerve injury, increased pain or the need for more surgeries. These defective medical devices could even cause "spinal kyphosis" or a spinal deformity that results in curving of the spine, which leads to a hunchback or slouching posture.
Surgeons and hospitals, who are using these medical devices have been told by the FDA to stop using them right away. The recalled medical devices were manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009. FDA officials issue Class I warnings only for those medical devices that have the potential to cause serious personal injuries or death.
Medical Device Industry Goes Under the Regulatory Radar
It is indeed unfortunate that the medical device industry is not subject to stringent approval standards. This lackadaisical approach to this issue puts millions of Americans who count on these medical devices, at serious risk. According to a Governmental Accountability Office (GAO) report in January 2009, between 2003 and 2007, the FDA approved 228 medical devices without full safety and effectiveness evaluation. About 20,000 companies manufacture medical devices in this country.
This is a $200 billion industry in the United States. There is a lot of pressure on federal regulatory agencies such as the FDA to get these products in the market at the earliest. Once these devices are in the market, these medical device companies leave no stone unturned to aggressively market and sell their products to surgeons and hospitals, regardless of how safe or effective those products are. Once again, this becomes a story of corporate greed – where a company is putting profits over people.
If you or a loved one has been seriously injured as a result of a defective medical device, please consult with a reputable personal injury lawyers, who has successfully handled defective product cases and will explain your legal rights and options. The best product defect law firms will always offer a free and comprehensive consultation to injured victims or their families.
The BISNAR|CHASE personal injury law firm is not representing any of the parties mentioned in this article at the time the article was posted. Our information source is cited in the article. If you were involved in this incident or a similar incident and have questions as to your rights and options, call us or another reputable law firm. Do not act solely upon the information provided herein. Get a consultation. The best law firms will provide a free consultation. We provide a free, confidential consultation to not at fault persons named in this article. The free consultation offer extends to family members as well.
