Essure® Lawsuits | Birth Control Device Inuries & Litigation
Women have a number of birth control options, but one intended to offer a permanent effect is Essure. The device is a surgical implant, and when placed correctly it works. The Food and Drug Administration approved the product in 2002. But in far too many cases, Essure’s placement leads to serious injury, infection, and even death. The number of such Essure birth control device complications may qualify for inclusion in a class action lawsuit.
Essure is form of barrier form of birth control. After being implanted in the fallopian tubes, the coil-shaped metal device prompts the formation of tissue around the coils which blocks sperm from reaching the eggs, explains HealthDay. That approach is effective in stopping pregnancy. The problem with Essure is that the device has also prompted a large number of injury complaints. Nearly 10,000 injury reports have been made since the product was approved, according to the FDA.
Due to the large number of injury reports, the FDA has issued a stern warning on the labeling of Essure, which serves as notice to both physicians and patients. Besides a prominent boxed warning on the product’s packaging, Essure now also carries a patient decision checklist intended to make sure that women understand the risks associated with the product.
Those risks are extensive. Reported injuries include:
- Heavy bleeding
- Chronic pain
- Fatigue
- Allergic reactions to metals in the device
The injury risks may become serious enough to cause death. According to MassDevice, some women became pregnant after using Essure and in at least five of those instances, the pregnancy led to fetal death. In four other cases, women died due to infection or internal injuries associated with the device.
The FDA is trying to better understand the injury risks of Essure, and the regulator has asked Bayer, the product’s manufacturer, to conduct additional studies that gauge those risks. Based on this research the FDA said it will decide what it will do next to protect public health. If you have used Essure and have experienced pain or other injuries, you may have a legal case. Contact us to learn more about your options.
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