Bringing a medical device to the market can often be a slow, ineffective process. This is due to the amount of requirements and restrictions in place to ensure products are safe enough for the public. While safety is always top priority, this frequently delayed process can hurt the medical industry by being an unattractive investment for start-ups and venture capital firms.

To combat these issues, the FDA allows certain innovative devices the ability to bypass some restrictions and market to the public more quickly, with the expectation that the company will collect important patient data via post-market surveillance. But how does this play out in real life?

According to a study from the Journal of the American Medical Association, post-market research is rarely conducted and often with a limited number of patients. Nearly half of all studies are funded without any manufacturer support, suggesting that these companies are using expedited approvals without a genuine commitment to follow-up. This lack of involvement is a disadvantage to individuals utilizing the products, as there is a potential for complications that could affect significant numbers of the population.

What does this mean for patients?

As a patient, doing research of your own into the drugs or medical devices prescribed by your doctor is important. Look into whether the product has significant post-market research data and understand the risks associated with treatments that haven't been fully explored by the FDA.

If you've already developed complications due to a product or device lacking adequate safety and effectiveness testing, then it's time to get the help of an experienced medical malpractice lawyer. Seeking treatment for medical issues should not be something that causes additional pain and issues due to untimely research. Your health and safety should be the top priority of medical device manufacturers, and the experienced team of attorneys at Lipkin & Apter is diligent at ensuring you receive the compensation you deserve in unfortunate situations like these.

Learn more about our experience in medical malpractice and personal injury law and contact us if you believe you are entitled to compensation for you or a loved one's injury or death due to inadequate follow-up research by medical device makers.