Severe and Life-Altering ESSURE® Complications
Numerous cases have been reported and many studies have shown that ESSURE® can cause serious side effects and health complications. Thousands of adverse reports have been submitted to the FDA since the device’s approval in 2002. Although a recall has not been issued, Bayer, the manufacturer, is under greater scrutiny. Many of the complications associated with ESSURE® are so severe that women have had to have hysterectomies. These complications are life-altering and cause irreversible damage. If you or a loved one has suffered ESSURE complications, our attorneys in San Diego, CA, can find out the best course of legal action for your particular case.
Non-Surgical, Permanent Birth Control
ESSURE® is the only FDA-approved non-surgical form of permanent birth control. Traditional birth control methods involve a surgical procedure commonly referred to as a woman getting her “tubes tied”. By comparison, ESSURE® birth control consists of two metal coils that are inserted into the fallopian tubes. These implants then embed themselves in the fallopian tubes and scar tissue develops around them, sealing the tubes off. Bayer claims the device is nearly 100% effective in preventing pregnancy.
In some women, because the device migrated and standard ESSURE® removal was not possible, a complete hysterectomy was necessary.
In addition to the purported effectiveness of the device, other benefits include the quick and convenient nature of the procedure. A doctor can perform the procedure in his or her office in about 10 minutes. No anesthesia is required.
Complications Involved During the ESSURE Procedure
The placement procedure itself is associated with some unpleasant side effects. Most women experience pain and cramping akin to what they might feel during their menstrual cycle. Nausea, vomiting, dizziness and lightheadedness, and fainting are all common side effects a woman might experience during or immediately following the procedure.
There is also a risk of perforation of the fallopian tubes or other organs and device expulsion shortly after the procedure. Furthermore, there is a risk of an ectopic pregnancy, or the formation of a fertilized egg in the fallopian tubes rather than the uterus. This can cause damage to surrounding organs and result in a significant loss of blood.
Long-Term Health Complications
Many women experience heavy bleeding during their menstrual cycles and chronic pain with ESSURE®. There is also risk of device migration, which can damage other organs and cause internal bleeding. In some women, because the device migrated and standard ESSURE® removal was not possible, a complete hysterectomy was necessary. A hysterectomy has long-term consequences, including bowel dysfunction and incontinence. The FDA has received reports of at least five fetal deaths associated with ESSURE®. Additionally, four women have also died from ESSURE® complications, including infection and suicide.
Difficulty in Taking Legal Action
Unfortunately, because of the Medical Device Amendment Act, suing Bayer is much more difficult. This act requires the FDA to more carefully scrutinize medical devices before approval, protecting the manufacturer from lawsuits. With the thousands of adverse reports, as well as a recent study showing that ESSURE® is not nearly as effective at preventing pregnancy as Bayer claims, many women still plan to file lawsuits.
Lawsuits involving claims against Bayer for ESSURE® complications are more complex than most defective drug cases. For this reason, it is essential to work with one of our experienced attorneys.
Schedule a Case Evaluation
If you suffered permanent and irreversible side effects and complications resulting from ESSURE®, seek legal counsel with our attorneys for effective representation throughout the legal proceedings. Contact our law firm today to schedule your free case evaluation.