After more than a decade of injury reports and lawsuits, Bayer is finally stopping sales of the Essure birth control device. Currently only available in the United States, Essure will no longer be available as of the end of 2018. For many readers, this news may seem like a long time coming. Read on to learn more about the Essure device, the dangers and associated impacts on women, and what you can do to protect your legal rights.
What is the Essure Birth Control Device?
Essure is a birth control device that has been heralded as the only non-surgical sterilization method for women. The device is made of two nickel-titanium coils, and is small enough to be inserted into the fallopian tube. Once inserted into the fallopian tube, the body reacts to the device and builds scar tissue, which blocks sperm from reaching the woman’s egg.
According to the Essure website, one Essure device is placed in each fallopian tube. The procedure to implant the devices is considered minimally-invasive, and can be performed in most doctor’s offices. Essure is inserted through the vagina and cervix, and does not require surgical incisions.
Essure is advertised as permanent birth control with “no cutting”, “no visible scars”, and covered by many insurance carriers. Thousands of women trusted the promise of permanent birth control and less side effects than hormonal options. Unfortunately, the risks associated with Essure have not been given the proper attention needed to keep consumers safe. What’s more, despite numerous warnings and regulations by the Food and Drug Administration (FDA), Essure has continued to be offered to women.
Many patients do not realize the obligations that manufacturers have to ensure their products are safe and effective. If you have been injured by Essure or another medical device that has malfunctioned or is defective, it is important to take action and hold the manufacturer accountable.
Start Your FREE Case Review Today
If you or your child is injured as a result of medical negligence, call us to learn more.
Numerous Complaints about Dangerous Device
Since Essure was approved in 2002, more than 750,000 women have been implanted with the device. There have also been tens of thousands of complaints about adverse reactions and side effects. So many complaints, in fact, that the FDA has warned Bayer and ordered additional testing and studies since that time.
In 2016, the FDA issued a warning about the product, which led to a 70 percent decline in sales. Unfortunately, it was too late for a significant number of women who trusted the device. There are currently more than 16,000 women participating in lawsuits against Bayer related to the risks and the fact that many serious risks were not on the packaging. The original packaging only listed allergic reactions as a possible side effect. Current packaging (after numerous restrictions and warnings) lists rash, hives, and swelling as well.
More serious risks are included in the FDA labeling, but are not included in the packaging, including headaches, hair loss, mood disorders, and weight gain. Many women also have reported that they were not warned of the dangers of migration or perforation, or how complicated removal could be if necessary. Several women have reported having to have a hysterectomy in order to remove the device.
Have Doctors Ignored Recommendations?
Like most medications or medical products, Essure has a list of factors that may make it an inappropriate choice for certain consumers. Essure is not recommended for women who:
- are unsure about permanent birth control
- are already pregnant, or have been pregnant recently
- only have one fallopian tube, or have an obstruction in one or both
- have had a tubal ligation (tubes tied)
- have unexplained vaginal bleeding
- are allergic to contrast dye or the materials used to make Essure
- have cancer of the reproductive organs, or who are suspected to
These factors may impact the effectiveness of Essure, or may contribute to other complications or side effects. News sources have weighed in on the possibility that doctors were promoting Essure for financial reasons, even if the device was not the best choice for the patient – despite these warnings. In July 2018, CNN reported that Bayer paid out $2.5 million to 11,850 doctors. This money was related to consulting and related fees for the product. While legal, this sort of payment, or incentive, is incredibly controversial and raises the question of whether doctors are influenced by financial gain.
Risks Associated with Essure
If none of the above factors apply and Essure is inserted, then women are at risk for complications during and after the procedure. These risks have not received as much attention as deserved in order to protect women. Risks include:
- Mild to moderate pain
- Breakage of the device
- Perforation of the fallopian tube or uterus
- Absorption of the salt water solution used for the procedure
- Side effects associated with local anesthesia
After the Procedure:
- Mild to moderate pain
- Cramping in the pelvic area and back
- Vaginal bleeding
- Nausea and vomiting
- Dizziness or fainting
- Expulsion of the device from the body
- Acute pain, which may be exacerbated by other gynecological conditions
- Migration of the device to other parts of the abdomen
- Allergic reaction to the materials in Essure (stainless steel, nickel, titanium, polyester fibers, silver-tin, and platinum)
- Unwanted pregnancy (Essure is not considered 100 percent effective. In premarket trials, three out of 503 women became pregnant while Essure was in place)
- Ectopic pregnancy (pregnancy located in the fallopian tube)
- Surgery to have the device removed
Protecting Your Health and Legal Rights
It has taken numerous warnings and concerns from the FDA and thousands of lawsuits for Bayer to decide the best course of action is to pull Essure from the market. The company cites that safety and effectiveness are not factors in their decision – but rather, declining sales. Even though their product has been shown to have risks and injure patients.
Protecting your health and legal rights is important to you, and to us here at Birth Injury Guide. If you have questions about Essure lawsuits, medical malpractice, or birth injuries, contact us to schedule a free case review. Fill out our online form, or call us at 1-877-415-6603.