Some medical devices are touted as being better alternatives to traditional measures used to treat various medical conditions. However, are such claims too good to be true? According to a new documentary, “The Bleeding Edge,” people in Texas and throughout the United States should be skeptical of the medical device industry.
For example, some medical devices like metal hip implants or transvaginal mesh were once seen as necessary to treat various conditions. However, physicians would even recommend elective medical devices, such as an intrauterine device (IUD) or breast implants. The problem is that medical devices often go unregulated and often are not sufficiently tested before being used on patients. Unfortunately, this means defective medical devices are slipping through the cracks causing patients to suffer worsened conditions or even death.
One person in the film, a surgeon, had a metal hip replacement that ended up falling apart in his body, ruining the tissue in the area of the implant. Another person in the film had a transvaginal mesh implant. However, the implant caused her unbearable pain and abdominal bleeding after it became fused to her organs. Other women in the film had a vaginal contraceptive known as Essure implanted in their bodies, only to have it fall apart and spread to other parts of the body, which caused the women to suffer many conditions including autoimmune and neurological disorders.
The documentary states that the U.S. Food and Drug Administration does not have as stringent of standards for medical devices as it does for other products it regulates. Moreover, the Trump administration has introduced further cuts to FDA regulations, allowing medical devices to quickly enter the stream of commerce, even if they might be defective.
This documentary brings to light some disturbing information on the use of defective medical devices. Lawsuits have been filed on behalf of those harmed by defective medical devices, including transvaginal mesh, metal hip implants, and more. These product liability claims aim to provide compensation to those who have suffered complications due to defective medical devices that have had a significantly negative impact on their lives. Oftentimes defective medical device litigation is the only way victims can be compensated for the financial and physical damages imposed upon them by a defective medical device.