Essure Lawsuits Grow To Record Numbers After Connection To Health Risks
Essure, a permanent birth control device implanted in approximately 750,000 women worldwide, is facing accusations about its connection to serious health complications. Lawsuits filed against the manufacturer state a failure to warn about the risks linked to the device, sometimes leading to life-threatening conditions.
According to the FDA, roughly 500,000 women in the U.S. undergo a surgical procedure to be sterilized each year. However, in 2002, an alternative solution was produced: Essure. A permanent, non-surgical birth control device, Essure has been implanted in roughly 750,000 women across the world since coming to market. Much of its popularity stems from:
- Easy procedure requiring no surgery
- Quick recovery time
- No hormones
Developed by Conceptus Inc., a company owned by Bayer, Essure brings in millions of dollars every year. Inserting Essure takes a 10-minute procedure that involves positioning a flexible, spring-like device in the woman’s body. Upon completion, tissues will grow in and around the device to create a barrier to prevent conception. This process can take several months, so many women are prescribed other methods of birth control in the interim. Approximately three months after the device is implanted, a radiologist will do an examination to ensure the fallopian tubes are completely blocked.
Recently though, the device has caused a stir among women due to its dangerous risks. Now, thousands of Essure lawsuits are piling up, claiming profits were more important to manufacturers than the safety and efficacy of the device.
Serious Side Effects Linked To Essure
Like many other medical devices that list common side effects, Essure identified several short-term risks associated with the product. Within the first few hours or days of the device’s implantation, women may experience:
- Moderate pain and cramping
- Back discomfort
Unfortunately, Bayer failed to list potentially serious side effects that can cause irreversible damage to women’s bodies. Shocked about unknown health complications, more women are now concerned that other dangers may come to light over time.
Reports of severe risks associated with Essure include:
- Life-threatening ectopic pregnancy
- Puncturing of the uterus or fallopian tubes
- Severe migraines and allergic reactions to the device
- Multiple surgeries to remove the device and repair internal organs
- Expulsion of the device
- Chronic pelvic pain
In October 2015, the BMJ released data from a study relating to the safety and effectiveness of Essure versus that of tubal ligation. The results were surprising – women with an Essure device were 10 times more likely to require surgery during the first year than those who had a tubal ligation. Additionally, although Essure is marketed to be 99 percent effective, recent research has indicated that the device may fail around 10 percent of the time. These newly released statistics are alarming to many women who now face difficult decisions about their health.
FDA Investigates Essure Allegations
Since Essure’s initial distribution, more than 20,000 women shared stories on social media about how the defective device put them in danger. Numerous other negative accounts were submitted directly to the FDA over the course of just two years. Soon after, the organization announced how it would provide women with the appropriate resources needed to make better informed decisions about their permanent birth control methods.
As of February 2016, the FDA ordered the Essure label to include a black box warning about the serious side effects. Along with this regulation, a new patient decision checklist was developed and will require both a patient’s and doctor’s signature before the device is implanted. While reviewing the checklist, patients will also need to agree to a test in three months which will make sure the device is functioning as anticipated.
Lawsuits Against Essure Manufacturer
More women are filing Essure lawsuits against manufacturer Bayer alleging that the company did not fully inform the FDA of all problems associated with the device. Moreover, various cases state that the manufacturer withheld critical information from consumers and failed to properly warn them of potentially life-threatening effects.