One of the top plaintiff trial lawyers groups in the country recently sent a public message to the U.S. Food and Drug Administration that asked the regulatory body to keep all-metal hip implant manufacturers from adopting proposed new changes to how the devices are approved, Reuters reports.
According to the news source, the legal group said that if the manufacturers move forward with the approval process, they could face legal liability for defects in the products. Although the metal-on-metal devices have proven to be more durable than other materials used – such as ceramic or plastic – they also come with serious health risks. This includes bone and soft tissue damage caused by debris that falls off the products. Already, many lawsuits have arisen due to similar occurrences.
To protect consumers from these potentially defective products, the FDA developed a new requirement that, if made into a law, would force manufacturers to undergo a more intense review and testing process. This would affect both devices that are already on the market as well as all products that are currently under development.
A new approval process
The media outlet noted that this is a large leap from the current approval process, which only requires companies to prove that their medical devices are close enough to products already on the market that further testing isn’t necessary. To show it’s support for the more extensive testing – and to keep manufacturers from overturning the proposal – the American Association for Justice sent a letter to the FDA.
In the letter, the group also stated that the FDA will need to take measures to ensure that those who have already filed claims against metal hip implant companies get their compensation.
“It would be absolutely unfair … if these claims all of a sudden were thrown into jeopardy solely because the government determined that the products needed additional safety testing before being marketed to consumers again,” wrote Mary Alice McLarty, the president of the American Association for Justice, in the letter.
Issues over metal-on-metal hip implants have been reported for years. One of the most recent recalls and batches of lawsuits can be traced back to July 2012, when Stryker was forced to recall its Rejuvenate and ABG II hip implants. The products were found to be susceptible to fretting and corrosion, which can cause pain, swelling and other physical reactions.
By focusing on the testing phase of metal medical devices, firms can lower the chances of suffering from costly recalls and lawsuits.