Consumers are the Guinea Pigs for Defective Medical Implants
By David Carnes, staff writer.
A medical implant is a manmade device that is inserted into your body for medical reasons. Examples include hip implants, lap bands and surgical mesh.
While the U.S. Food and Drug Administration (FDA) requires extensive testing before allowing a new pharmaceutical on the market, FDA standards for new medical implants are far more relaxed, including less stringent advance testing requirements. Possible consequences of these relaxed standards include a variety of medical problems associated with the use of some of these devices.
The truth is that consumers are unwittingly participating in the “advance” safety testing of these devices. Following are some examples of medical devices that have been the subject of significant litigation or frequent complaints.
DePuy Hip Implants
Two DePuy hip implant models have become the focus of hundreds of lawsuits. Both of the controversial models feature “metal on metal” designs in which a metal ball slides against a metal socket, resulting in the release of metal residue into the body. Plaintiffs in the lawsuits allege that this type of hip implant has been responsible for broken and dislocated hips as well as damage to organs such as the heart, thyroid and kidney.
Lap bands are anti-obesity devices used to squeeze the stomach so that the user avoids overeating. Reports of nausea and vomiting exceed 50 percent of users, and complications such as damage to the stomach lining are not uncommon.
Transvaginal mesh is a type of surgical mesh that is inserted through the vagina to treat incontinence and certain other conditions. It has been placed into hundreds of thousands of women. Transvaginal mesh can shift inside the body causing excruciating pain, nerve damage, infections and other problems.
Sending the makers of these dangerous devices to jail would be a just consequence of their negligence, but it probably won’t happen. Short of that, the obvious long-term solution is for the FDA to beef up testing standards for medical implants until they are just as stringent as the standards for new pharmaceuticals.
Merely beefing up approval standards, of course, would not solve the problem with respect to medical implants that are already on the market. A practical solution for medical implants currently on the market would be to allow manufacturers a certain period of time to submit existing products for FDA approval under the new standards. These products would then remain on the market, with accurate warnings, until receiving either a “thumbs up” or a “thumbs down” from the FDA. Products that received a “thumbs” down would have to removed from the market pending modification and freash FDA approval.
If you believe that you have been harmed by a medical implant, you can learn more about enforcing your rights and how to recover compensation for your losses by searching our directory to find an attorney near you.
Read more about defective medical devices.