Essure is a prescription-only permanent birth control solution that requires a procedure which creates a natural barrier from pregnancy.
This type of birth control is said to be 99.74% effective which is the best performance rate amongst all permanent birth control products. The procedure does not require an incision and instead soft inserts made of stainless steel, nickel titanium, and polyethylene materials, are moved through the body's vagina, cervix and uterus and eventually into a patient's fallopian tubes. While the procedure only takes about 10 minutes, the barrier is permanent.
After the procedure, approximately three months must pass before the natural barrier is formed to keep sperm away from a woman's egg. At the conclusion of the three-month period, the patient must undergo an Essure Confirmation Test to make certain that the procedure held and the patient is protected.
Essure birth control was created by Conceptus, Inc. and first approved by the Food and Drug Administration (FDA) in 2002. The approval was granted via a fast-track process known as the FDA's 501(k) premarket process. The process allows approval without testing as long as the design and functionality of the product are based upon a device that the FDA approved in the past. The reasoning for the fast-track is to provide sorely needed drugs and devices to consumers as quickly as possible. The 501(k) approval of Essure birth control was conditioned upon the requirement that Conceptus, Inc. continue to study users for four to five years following the procedure. The findings were the following:
- 38% had unusually heavy menstrual cycles
- 5% had recurrent pelvic pain
- 4% had painful intercourse
Conceptus, Inc. was later acquired by Bayer who continued to market the product as the only FDA-approved permanent form of birth control with a procedure that can be performed in an office setting without general anesthesia.
Common complications associated with Essure Birth Control include:
- Perforation of the fallopian tube
- Neurological damage
- Autoimmune problems
- Hair loss
- Pelvic pain
The FDA examined an increasing number of adverse event reports associated with the use of Essure birth control. The negative effective included within the reports are persistent pain, perforation of the uterus, perforation of fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions.
Another complication associated with Essure, is an actual risk of pregnancy. Researchers found that almost 10% of women using Essure as their sole method of birth control could become pregnant. That percentage is almost four times the risk of traditional tube ligation.
The FDA, after careful consideration, has recommended the following:
- Potential Essure patients be carefully selected
- Physicians receive better training
- Potential risks need to be disclosed to potential patients on a more regular basis
- Women who are sensitive to the materials associated with Essure should not undergo the procedure
- Women who have autoimmune disorders or who have previously undergone uterine surgery should not undergo the procedure
The FDA has begun to require a black box warning in addition to more safety studies for Essure. A black box warning is the FDA's strongest warning and will inform patients in detail about adverse reports associated with the product. The impetus behind the warning is to encourage important conversations between women and their physicians in order to make more informed decisions about whether Essure birth control is the right procedure for them.
While thousands of women have tried to obtain justice against Bayer for injuries they claim stemmed from the use of Essure birth control, their success has been limited due to something called preemption. Preemption is a legal theory in the United States that exempts product manufacturers from tort claims regarding FDA approved products. While preemption has been a major road block, the tide may be turning as recent events have led to positive movement within the court system for plaintiffs claiming that the Bayer product caused their injuries.
In April of 2016, a federal judge dismissed a number of counts contained within five lawsuits brought against Bayer by women claiming that Essure birth control caused permanent injury. However, the judge did allow claims of failure to warn and negligent misrepresentation to proceed. Those lawsuits will continue with claims of negligent manufacture, negligent risk management, breach of express warranty, negligent training and fraudulent manufacture.
In October of 2016, a California judge ordered that all California product liability lawsuits against Bayer and several subsidiaries involving Essure birth control device be coordinated before a single judge in Alameda County Superior Court. The ruling will facilitate efficient adjudication in the California court system and coordinate the efforts on behalf of all of the women injured by Essure birth control. Before the ruling, there were over 55 actions related to 900 women pending in the California court system. Having the cases coordinated will allow for cohesive and unified arguments in addition to consistent rulings.
Representation for Colorado Women Harmed by Essure
If you have suffered adverse health effects as a result of a faulty medical device, it is possible that you may be entitled to compensation. Consulting with an experienced and skilled medical device attorney is the first step to receiving the justice that you deserve. Since 2004, the law firm of Jeremy Rosenthal has focused exclusively on personal injury law and makes it their priority to put your best interest first while supplying you with first class legal representation. Call (303) 825-2223 today to schedule a consultation.