Just because a medical device or pharmaceutical drug is approved by the FDA doesn’t mean it’s exactly safe. Lots of devices and drugs receive FDA approval then go on to cause unreasonably dangerous side effects, which can lead to permanent injury and death.
Proper testing can never be guaranteed, and sometimes devices and drugs are missing adequate warnings or proper instructions for use. Although devices and drugs are created with the best intentions, they don’t always improve a patient’s quality of life; sometimes, they actually harm people instead.
Medical Device Adverse Events
Medical devices are supposed to be safe, and the FDA is supposed to guarantee their safety. It’s the FDA’s job to provide quality assurance on devices and drugs; unfortunately, many failures have occurred in recent years.
Take, for instance, the permanent birth control device: Essure, which was approved for use in women by the FDA. Despite its initial FDA approval, the device is responsible for a number of serious and life-threatening problems.
“In fact, the FDA received 5,093 complaints related to Essure between November 4, 2002 and May 31, 2015,” reports the law firm Heard Robins Cloud. The FDA finally held a hearing and determined that Essure wasn’t as safe as initially presumed. The birth control device then received a black box warning, which is the FDA’s most serious warning.
Despite FDA approval, nurses are often employed to monitor the effects of medical devices already brought to market. A medical device adverse event is when a device contributes to death or personal injury.
Although it’s unknown exactly how many medical devices cause adverse events each year, it is known that the FDA received 69,959 medical device adverse event reports from nurses in the year 2000. By 2009, the amount of reports had increased to 540,204. This staggering increase is proof that not all medical devices are safe.
Crystal Plumlee thought Essure would be perfect for her busy life (she has five kids and wanted no more), so she chose to have the metal coils implanted into her fallopian tubes. Now, she deals with excessive weight gain, regular joint pain, chronic fatigue, irregular heavy menstrual cycles, and unbearable headaches. She’s not alone. Many women have complained of similar experiences. Sarah Payne said, “When you stand up, it feels like someone’s taking your muscles or your insides and trying to pull them apart. It would take me to the floor.”
Other examples of medical devices that have had adverse events include:
- Transvaginal meshes
- Hip & knee implants
- Certain types of catheters
Medication Errors and Patient Safety
The effects of medications have been widely overlooked throughout the years. Patient safety has been put in critical danger due to oversights regarding side effects and dosage.
Risperdal is a brand of antipsychotic medication that was never approved for use in children, and yet Johnson & Johnson and its subsidiary Janssen illegally marketed it to pediatric patients. The resulting litigation is what the law offices of Heard Robins calls “one of the largest pharmaceutical deceit stories of our time.”
Many antidepressants were also marketed to young people, and turned out to be incredibly dangerous to their health. Selective serotonin reuptake inhibitors (SSRI’s) sometimes cause suicidal thoughts and actions.
When you consider that even some of our first responders take these drugs to deal with their depression, the issue of their safety becomes increasingly more important. It’s actually quite terrible that the drug designed to help alleviate symptoms of anxiety and depression actually have the power to make you consider suicide.
If you’ve ever suffered injuries or serious side effects after using a medical device or taking a pharmaceutical drug, you may have a defective product liability claim. You can obtain an attorney, and in doing so you may be protecting others from a similar fate.
Finally, it’s extremely important that you report any adverse effects to medical staff, so you can help ensure that others don’t become victims themselves.