Have you been injured in Texas because of a Stryker medical device?

The Houston medical device injury attorneys at Denena & Points note that Stryker Corporation, like other medical devices, typically seeks to put its medical device products on the market without clinical trials or extensive testing. The bulk of medical devices enter the U.S. market under the FDA expedited approval process. The expedited approval process does not require a manufacturer to engage in testing or clinical trials if it says that its new product is substantially equivalent to a medical device product already on the market.

The FDA expedited approval process saves the manufacturers and the agency enormous amounts of time and money. But the weaknesses in the system have already been show. Surgical mesh repairs of prolapse, for instance, which were predicated upon surgical mesh repairs of hernia, have been shown to not be substantially equivalent after all. The transvaginal surgical mesh repairs have caused serious pain and injury to hundreds of women.

And Synthes, another medical device company, decided to make an end run around the FDA approval process and put its Norian XR product on the market without the required IDE that the FDA required. Our Houston medical device injury attorneys point out that the Norian XR product has since been linked to a number of severe injuries and fatalities.

Some time back, we wrote about a major recall from Stryker Corp. The company pulled its Rejuvenate and ABG II modular-neck stem devices involved in hip replacement surgeries. The metal-on-metal stem and neck could grind together and produce wear and metal flaking linked to a condition called metallosis. Research has shown a high incidence of kidney and bladder disease and failures from the metallosis condition.

And metal-on-metal hip implants have been shown to have failure rates overall. With the Rejuvenate and ABG II recall, Stryker had appeared to try to place the blame for defective product performance with the surgeons that installed the implant and the ill patients with pre-existing conditions like diabetes who required the implants.

In its current recall, Stryker is expanding a Class I recall for certain models of its Neptune Waste Management System. Our Houston medical device injury attorneys emphasize that Class I recalls are the most serious category of recall, indicating the danger of serious injury or death. In this recall, Stryker does not appear to be trying to lay the blame with doctors and patients.

The company does note that their Neptune medical devices do not have required approval from the FDA. And so the FDA has not determined whether these Neptune Waste Management Systems are safe for use or not.

However, actual uses of the product without the required FDA clearance indicate that the medical device product is not safe. Stryker has received at least two reports of serious bodily injury and tissue damage from use of the product. Our Houston medical device injury attorneys caution that at least one use of the product resulted in fatal injury.

The Neptune Waste Management System is a medical device used to collect and dispose of surgical waster fluids. Stryker specifies that instructions for using the product did not specifically warn users against the danger of connecting the Neptune Rover (the high vacuum, high flow device) to a passive drainage tube. And that failure to be precise has apparently caused some patients good tissue and one patient his or her life.

Stryker it seems is telling customers of the product to review revised instructions and educate Neptune users about the warning. Our Houston medical device injury attorneys would suggest that maybe customers abandon use of the product until it has been adequately tested and approved and the FDA has had a chance to determine whether the Neptune medical device is safe or not.

The Neptune medical device products are being marketed illegally as the FDA hasn’t determined their safety and effectiveness. The FDA advises against use of the Neptune medical devices until they can be properly tested and approved by the FDA.

The expanded Stryker recall affects the Neptune I Silver, the Neptune 2 Ultra (120 V), and the Neptune 2 Ultra (230 V). Stryker says that it will cease distribution of these devices until the FDA clears them. We wonder if the company’s adoption of this stance could have anything to do with a deterrent effect resulting from the recent prison terms accorded to Synthes executives who illegally marketed a medical device without proper FDA approval.

Contact the Houston medical device injury attorneys at Denena & Points for a free initial consultation if you have been injured in Texas because of a defective Stryker medical device. Our Texas Board Certified personal injury attorneys have a top tier range of expertise, trial experience, and professional dedication in the field that could help you obtain the full financial recovery you deserve for your serious injury.

We’ve been helping victims and their families that have been hurt by defective medical devices to win their claims against the big manufacturers for over a decade. Let us put our knowledge and skill to work for your benefit. Contact our Houston medical device injury attorneys today for your free case evaluation consultation.