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Many patients assume that if a medical device is approved by the Food and Drug Administration (FDA), it must be safe. Unfortunately, this is not always true. Every year, thousands of people suffer serious injuries from devices that made it past FDA review and into hospitals and clinics.

The process for bringing a medical device to market follows one of two main FDA pathways: 

• Premarket Approval (PMA) — This requires manufacturers to conduct extensive clinical trials and submit rigorous testing data. 

• Premarket Notification (510(k) clearance) — This requires only that a new device be “substantially equivalent” to another device already approved. 

Since a 510(k) clearance is the most common pathway, many products bypass clinical trials entirely. When companies base their new devices on outdated or hazardous models, risks aren’t detected until large numbers of patients begin to use them. Post-market oversight isn’t much better. Manufacturers are responsible for self-reporting adverse events, but underreporting and late reporting are widespread. Often, the FDA recalls a product only after it has already harmed thousands.

Why do some dangerous devices stay on the market far longer than they should? The answer is a mix of financial, regulatory and legal factors: 

• Medical device companies earn billions from selling popular products. Hospitals and physicians may also have financial incentives or relationships that help keep these devices in use. 

• Regulatory action is often frustratingly slow. FDA investigations and recalls take months or years, allowing harmful devices to injure more people. 

• Aggressive marketing campaigns by manufacturers can minimize known dangers and exaggerate benefits, so neither doctors nor patients have the full picture. 

Devices commonly associated with serious problems include hip and knee replacements, hernia mesh, pelvic organ prolapse mesh, IVC blood clot filters, insulin pumps, CPAP machines, ventilators, pacemakers and artificial heart valves.

Oklahoma patients injured by dangerous medical devices have legal remedies. They can bring product liability claims, which focus on design flaws, mistakes during manufacturing or failures to warn of risks. Injured parties can sue not just manufacturers but also distributors, sales representatives and, in some cases, hospitals or surgeons. Victims may be eligible for compensation covering medical costs, lost wages, pain and suffering, long-term disability and punitive damages if the conduct was reckless. 

If you suspect a medical device has harmed you, seek medical attention, document all symptoms, preserve the device (if removed) and speak with an experienced Oklahoma product liability attorney. It is important to act quickly, since Oklahoma law imposes strict time limits on injury claims.

At Walsh & Franseen in Edmond, we champion the rights of Oklahoma consumers who are injured by dangerous products. Call us at 405-843-7600 or contact us online to arrange a free case evaluation.