Attorney at Graves McLain Injury Lawyers
Practice Areas: Wrongful Death, Medical Malpractice, Bad Faith Insurance, Car Accidents, T-Bone Tractor-Trailer Accidents, Dangerous Drugs
Medical devices are meant to improve lives, not cause more harm. Yet according to the U.S. Food and Drug Administration (FDA), faulty medical devices have been linked to over 1.7 million injuries and more than 83,000 deaths worldwide in the past decade. Many of these injuries could have been prevented if safety checks and oversight were stronger.
This post provides a closer look at the devices causing the most harm, the approval process, and what injured patients in Oklahoma can do if they’ve been affected.
The FDA has logged over 1.7 million injuries and 83,000 deaths linked to medical devices over the past decade. — FDA MAUDE Database.
Thousands of complaints are filed every year about medical devices that break down, fail to work as promised, or make a patient’s condition worse. While some issues may come from normal wear and tear, many result from poor design or rushed approval.
Devices frequently involved in these complaints include:
Spinal cord stimulators have caused over 80,000 injuries and 500 deaths since 2008, despite being marketed as a safe alternative to opioids. — International Consortium of Investigative Journalists.
Spinal cord stimulators are implanted under the skin to deliver electrical pulses to the spine, aiming to stop pain impulses from contacting the brain. Nearly 60,000 of these devices are implanted each year in the U.S.
But for many patients, they’ve caused more problems than relief. Since 2008, the FDA has received more than 80,000 injury reports and 500 deaths linked to these devices. Malfunctions include battery issues, shocks, wire migration, and failure to control pain.
Some patients report needing multiple surgeries to remove or replace the device, and others say their pain worsened after the implant. Despite these risks, the devices are still widely used.
The FDA is responsible for reviewing and approving medical devices before they’re sold in the U.S. But the system in place—especially for moderate-risk devices—has serious flaws.
Most devices are cleared through a shortcut called the 510(k) process, which allows approval if the device is similar to one already on the market. This means that many products are sold with little or no new testing.
Under the 510(k) process, many devices are cleared based on their similarity to previous products—without requiring new clinical trials. — FDA Guidance on Medical Device Regulation.
According to FDA sources:
Approximately 20% of approved devices are based on technology that’s over a decade old. — FDA Device Advisory Panel.
In other words, many devices in use today are built on outdated designs, and safety concerns often come to light only after serious injuries occur.
The FDA has acknowledged the need for change and is working to modernize its device approval process. Until then, patients and doctors must stay informed and cautious.
Here’s a breakdown of FDA-reported injuries and deaths tied to major types of medical devices over the past 16 years:
Device Type | Injury Reports | Death Reports | Common Complications |
| Spinal Cord Stimulators | 80,000+ | 500+ | Nerve damage, infections |
| Surgical Mesh Implants | 100,000+ | 500+ | Organ perforation, chronic pain |
| Hip/Knee Implants | 300,000+ | 4,000+ | Device failure, revision surgery |
| IUDs & Birth Control | 70,000+ | 300+ | Perforation, unintended pregnancy |
If a faulty medical device caused harm to you or someone in your family, you may possess the authority to bring a claim for product liability. These lawsuits hold device makers accountable when their products cause preventable injury.
It’s important to know that:
Graves McLain Injury Lawyers handles medical device and product liability cases across Tulsa and the state of Oklahoma. Our team understands how to build strong cases against manufacturers and can help you determine your next steps.
A medical device may be considered defective if it malfunctions, causes unexpected harm, or fails to perform as intended due to poor design, manufacturing errors, or inadequate warnings.
You can check the FDA’s Medical Device Recalls Database or the ICJ’s global Database for recall notices and safety alerts.
Document your symptoms, preserve the device (if possible), and seek immediate medical care. Then, consult an experienced product liability attorney to explore your legal options.
Yes. FDA approval doesn’t shield manufacturers from lawsuits if the device proves to be defective or harmful during regular use.
Oklahoma generally allows two years from the date of injury or discovery to file a product liability claim. However, legal deadlines can vary, so timely consultation is critical.
Compensation may include medical bills, lost income, pain and suffering, and costs of revision surgery. Every case is unique.
Faulty medical devices continue to harm patients across the country, including right here in Tulsa. While medical advancements can improve quality of life, safety can’t be overlooked. Spinal cord stimulators, mesh implants, and other devices have caused serious complications for thousands—and many could have been avoided with better oversight.
Graves McLain Injury Lawyers is dedicated to assisting victims of defective medical devices in understanding their legal rights. If you’ve suffered because of a device you thought you could trust, you don’t have to navigate this alone. Let our legal team help you move forward.
Please make an appointment for a free consultation with Graves McLain Injury Lawyers right now to find out how they can support your future.
When injury victims need a law firm with a reputation for excellence, turn to Graves McLain Injury Lawyers. We are a top-rated personal injury firm determined to be the best. With decades of award-winning representation, our clients recover the compensation they need to put their lives back together.
