Artificial medical devices, such as surgical mesh and artificial joint replacements, are becoming more and more popular as technology becomes more advanced. And with all the perceived medical research and funding that goes into the development of these devices, it’s easy to understand why consumers are quick to sign up for these artificial implants. But many Americans might be surprised to hear the research, or lack thereof, behind the development and release of these products and the frequency of side effects they have on patients who have received them.
America’s Growing Market for Medical Implants
Implanting medical devices is a relatively common procedure. As people age they turn to hip replacement products that provide increased range of motion without the pain.
Similarly anyone undergoing one of the hundreds of thousands of hernia repairs or similar procedures that occur each year is likely treated with surgical mesh, a product used to assist the healing of soft tissue cells.
Despite how regularly these products are sold and implanted into the bodies of consumers – Consumer Reports claims that tens of millions of Americans have some sort of implanted medical device – experts claim that the lack of proper testing trials is to blame for all of the defective medical device lawsuits we see each year.
“Often, the only safety ‘testing’ that occurs is in the bodies of unsuspecting patients,” reads a press release from Consumer Reports. “Many of these implants have never been tested for safety and manufacturers are usually required to do nothing more than file paperwork and pay a user fee before bringing their products to market.”
Are these side effects worth it?
But how could products that are going to be surgically implanted inside the bodies of American citizens be so unregulated? How could the government put the wellbeing of so many people at risk?
Consumer Reports cites a “broken regulatory system” as the culprit for these dangerous risks, explaining that the FDA’s 510(k) approval process for medical devices only requires manufacturers of invasive devices to fill out the appropriate paperwork and submit a $4,000 fee before their product is released to the market.
Consequently, the FDA has issued a number of recalls for medical devices in the last decade or so and there have been a significant amount of lawsuits pertaining to the side effects associated with the implants.
“Without major changes in the system, there really isn’t much consumers can do to protect themselves,” Consumer Reports’ press release continues. “We do urge people to ask their doctors about alternatives. Surgical mesh is a perfect illustration of a medical implant that is frequently unnecessary.”
Consumers Union, Consumer Reports’ advocacy branch, has issued a series of recommendationsfor the FDA to improve its safety testing policy and decrease the risk of serious injury to patients.
“Medical device industry lobbyists are working overtime to pressure Congress to preserve weak federal oversight that puts patient lives at risk,” says Lisa McGiffert of Consumers Union. “We need common sense reforms to assure consumers that these devices are safe and work like they are supposed to.”
Do you have any positive or negative experiences in dealing with a medical device implant? Share your thoughts and experiences with us in the comment box below. If you or a loved one has been a victim of any faulty medical devices, contact the Davis Law Group today at 206-727-4000 to learn more about your options.