Essure Lawsuit Update 2016: FDA Warns of Essure Risks
When you use a medication or medical device, you expect it’s going to work properly and safely. Essure is a birth control device used to prevent pregnancy. Originally introduced in 2002 by the FDA, some patients report serious injuries.
Serious medical problems now impact many Essure users. Some of these patients file Essure lawsuits to recover money.
Currently, patients filing lawsuits against the maker, Bayer, include claims of:
- Negligent misrepresentation
- Negligent manufacture
- Failure to monitor or test the device
- Negligent risk management
- Breach of express warranty
- Fraudulent representation
- Failure to exercise reasonable care
Any patient suffering injuries due to an Essure issue may be able to file a lawsuit. A defective drug attorney can help you.
How Essure Works
A doctor implants Essure in an outpatient procedure. It is chosen by medical professionals and women when there is no desire to ever become pregnant. This product is recommended for women who cannot do not want or cannot go through a hysterectomy.
Although Essure is FDA-approved, evidence shows it puts women at risk for serious injuries. If the device migrates elsewhere in the body, it damages the woman’s reproductive system. Some patients suffer ectopic pregnancies and other pregnancy complications.
A news station in Portland, Oregon, detailed how 2,000 patients struggled with injuries due to Essure. Patient reports discuss pelvic pain, unplanned pregnancy, and other issues.
Essure Side Effects
Essure users filing lawsuits report many symptoms following use of Essure, including:
- Menstrual irregularities
- Device migration pain and problems
- Weight change
- Allergic reactions
Many women go through hysterectomy surgeries to remove the device.
FDA Warns of Essure Risks
FDA officials reviewed more than 600 reports of women becoming pregnant after receiving Essure. In response to the numerous reports, the FDA still issues warnings concerning Essure.
Some users of the device file Essure lawsuits in response. Nearly a dozen Essure lawsuits have already been filed against Bayer.
Judges can bring these into a single case covering numerous victims. California is home to 200 pending Essure lawsuits alone. In early 2017, the process of discovery began in those lawsuits.
Lawsuits Regarding FDA Approval of Essure
Other lawsuits argue that the device approval was based on false information provided to the FDA. Essure got approval through an FDA fast-track program. That program gave approval to Conceptus, the first manufacturer. Officials promised to study Essure users for four to five years after implantation. That study wrapped up in 2007. Publishing that data took eight years.
Studies show that fewer than three-quarters of the women involved were followed for the entire five years. Some women in the study even came forward to the FDA. They stated that the information issued by the first creator about their use was not true.
What the FDA Learned About Essure
The FDA investigated and found at least six cases of potential tampering. The agency identified “sporadic tampering”, but found no pattern of intentional falsification. Patients continue to share reports about problems with Essure.
The government agency now requires black box warning be placed on Essure boxes. A black box warning label is for products that carry serious or life-threatening risks for patients. Between 2002 and 2015, more than 5,000 women in the U.S. filed FDA grievances about severe side effects caused by Essure. The FDA is still determining whether a complete ban on the devices is necessary.
At the end of 2016, the FDA began requiring a patient decision checklist on the drug’s label.
If you or someone you know suffering from Essure injuries, find a defective drug lawyer to help you with your legal case. If you suffer the symptoms above, get help from a doctor.