Medical implants promise to better people's lives, but many end up causing more harm than good. Take Essure, for example. A non-invasive solution to permanent birth control, Essure has harmed tens of thousands of women.
Are products rushed to the market before they are ready?
Part of the problem is insufficient testing. Dr. Diana Zuckerman -- the National Center for Health Research's president -- claims that manufacturers are skirting the necessary background testing before bringing devices to patients.
This is partly because of the Food and Drug Administration's relatively lax standards. While the threshold for demonstrating prescription drug safety is fairly high, medical devices can slide by with a much lower demonstration of safety and efficacy.
Essure: Just one out of many
Bayer manufactured Essure, which is a small nickel coil placed inside women's fallopian tubes. Bayer marketed it as a non-hormonal, permanent birth control solution that women could get during a quick trip to their doctor's office. The first women to receive Essure participated in clinical trials during the 1990s, but they say the received no warnings of potential side effects. In fact, Bayer told them it was already proved safe.
The FDA approved it in 2002, and since then approximately 27,000 women have reported adverse effects to the agency. Patients often cite extreme pain that Bayer never warned them of, and even doctors reported that they never received the proper training on placing the devices. One doctor said that Bayer representatives told him not to take the device out even if he accidentally misplaced it.
Too little, too late
Not just women are suffering. Although Essure is supposed to prevent pregnancy, many women still became pregnant afterward, which can be extremely dangerous. So far, the device has caused at least 303 fetal deaths. The FDA added a warning to Essure's packaging and told doctors to give patients more information, but Bayer did not pull the device from the market until a documentary about its dangers was set to hit Netflix.
As a patient, you should be able to trust medical device manufacturers to provide safe and effective products. When they shirk these responsibilities, the outcomes can be devastating and life-long. You do not have to deal with this alone, though. When you pursue legal recourse, you could not only obtain much-needed compensation, but you can also affect change that protects future Tennessee patients.