Zimmer Knee Study Doesn’t Look Good for Manufacturers

The Food and Drug Administration recently commissioned a study on the effectiveness of the FDA’s pre-market approval process for artificial joints such as the Zimmer NexGen and DePuy ASR and DePuy Pinnacle systems. The results of this study are about to be released – while, at the same time, proponents of the orthopedics industry are rushing to negate the impact of the results of the study before they are even published. It is likely that the study will recommend harsher regulations for the approval of new knee implant devices. The Food and Drug Administration is currently using a program that can “fast track” the medical device approval process, which has resulted in several products currently on the market which have a high rate of premature knee failure and other knee implant complications, including the Zimmer NexGen system.

The study, conducted by the Institute of Medicine, will likely have an impact on the way new medical devices are approved for use across the country. This could cut the risks for complications experienced by hundreds – even thousands – of patients, and will also likely reduce the number of patients having to undergo Zimmer knee revision surgery after experiencing knee implant failure. Knee revision surgery is a painful, complicated, and expensive procedure that is intended to fix problems associated with a knee implant failure in a patient.

Although the forthcoming study does not look like it will have good results for the manufacturers of certain medical devices, the benefits to patients and consumers could be boundless. And perhaps orthopedics manufacturers should be happy, as well – a less lenient approval process could lead to fewer Zimmer knee implant complications that these companies could be made legally responsible for. Already, many patients are looking into filing suit against Zimmer and other orthopedics manufacturers in order to gain compensation that could cover medical costs and other problems associated with the devices, including compensation for loss of quality of life.

Patients continue to seek legal advice and take legal action against the manufacturers of the devices that have hurt them. A policy change by the FDA could prevent even more lawsuits. The showdown between the company and Zimmer knee lawyers will be big news as time goes on.