Medical implants are constantly improving in the United States. With Americans living longer it appears that in many instances we are outliving our body parts! Millions of Americans currently rely on such devices. Medical implants can take the form of various devices, like artificial joints, heart devices, and surgical mesh. With the increasing use of such implants, however, the increase of liability and complications can arise as the need for such implants may be greater than the time it takes for such devices to hit the market.
Consumer Reports has provided a disturbing report which found that most medical implants have never been tested for safety. Consumer Reports found that for most implant manufacturers, all that is required for the product to enter the market is to file some paperwork and pay a fee with the Food and Drug Administration, the main regulatory body for such devices in the United States. Scarily, many of the implants are tested in the unsuspecting bodies of many Americans.
Some products that pose a higher risk require FDA testing, however, even those companies provide smaller testing studies with lower standards. As a result, litigation over such implants has resulted in many companies issuing recalls for such implants. Recently, Johnson & Johnson subsidiary DePuy settled a claim for about $4 million for their hip implants. The suit alleged the company deceptively claimed the device was safe when they knew there was a higher than average failure rate. The unfortunate result is that more surgery is needed to remove the device and install another one.
Surgical mesh has also been the subject of a lot of litigation, forcing the FDA to rethink its strategy on how companies can bring such products to the market. For some mesh products, like the trans-vaginal sling mesh, the FDA is now requiring post-market testing in order to continue to have the products on the market. Other mesh-like products, like hernia patches, have had FDA mandated recalls. With the side effects and litigation mounting for mesh implants, it will only be a matter of time before additional mesh recalls happen. It is important as a patient to be aware of the products that will be inserted in your body. Be sure to ask your doctor about the brand of the implant that will be used and do your research before surgery.
This article is for general informational purposes only and is not to be construed as legal advice. Do not rely on the above information as all cases are different and different laws apply to different cases. Consult an attorney in your area for further guidance.