Over the past few years, the U.S. Food and Drug Administration (FDA) have been checking into an increasing number of injury reports regarding the birth control drug Essure. On September 24, 2015, a meeting was assembled between the FDA and the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. This meeting was put in place to listen to expert clinical and scientific opinions as well as the experiences of patients’ regarding both the risks and benefits of Essure.
Essure, which is manufactured by Bayer HealthCare Pharmaceuticals, provides women with a permanent birth control solution (female sterilization). There is no surgical incision necessary for the implantation of Essure. The procedure involves the insertion of flexible coils into the vagina and cervix and then into the fallopian tubes, which carry the eggs to the uterus from the ovaries.
Tissue begins to form around the inserts within the first three months. This tissue buildup keeps sperm from getting to the eggs through a barrier it creates, which prevents conception. Essure is not meant to be removed since it is a permanent birth control solution.
There have been reports by women suffering with chronic pelvic pain that is possibly due to using Essure. The Essure insert could move into the pelvis and lower abdomen and could result in surgery to remove it. Other safety precautions include:
- It’s not a 100 percent effective form of birth control.
- Reversing the Essure procedure effectively and safely is not known.
- After the Essure procedure is done, risks involved of getting pregnant to either you or your fetus are not known.
- Ectopic pregnancies (pregnancies outside the uterus) are more likely to happen to women who get pregnant while on the Essure system.
- Essure can be life-threatening.
- Nickel-titanium alloy is included in the materials of Essure resulting in allergic reactions to the insert.
- The effectiveness and safety of Essure in women under the age of 21 and over 45 has not been established.
- Essure doesn’t protect you against sexually transmitted diseases, including HIV.
Essure Side Effects
Most doctors know about the side effects surrounding the Essure system, however, they still decide to prescribe it to women because they feel these side effects are outweighed by it being 99 percent effective at preventing pregnancy permanently, and the fact that around one million women have chosen the procedure.
However, some of the following symptoms could be experienced when using Essure:
During the Essure Procedure
There are some possible side effects that you could experience during the procedure which include:
- Mild to moderate pain.
- One or both Essure inserts might not be placed correctly by your doctor
- Essure insert could break off in rare cases. You can expel it naturally during your next period or the doctor can remove it.
- Your fallopian tube could get punctured by the Essure insert which may require surgery to repair it.
- Large amounts of salt water solution can be absorbed by your body (this solution is used during the procedure).
- A local anesthesia is often used to numb the cervix which has its own risks and should be discussed with your doctor.
Any possible side effects should be discussed with your doctor before you begin the procedure. Your doctor will educate you on what to expect and what can happen so you can make an informed decision if you want to proceed.
Following the Essure Procedure
There is always the chance of experiencing side effects following any procedure; the Essure procedure is no different. Some possible side effects include:
- Mild to moderate pain
- Vaginal bleeding
- Back or pelvic discomfort
- Nausea or vomiting
- Your body can expel the insert (rare case scenario)
Essure Drug Injury
A recent study, published in the British Medical Journal (BMJ) on October 13, 2015 raises new concerns regarding the insert. The study compares the efficiency between laparoscopic sterilization (fallopian tubes are blocked during this procedure) and the implantation of the Essure contraceptive device (non-surgical method).
During the study, researchers found that women who chose Essure had a 10-fold higher risk of having to go back in for a reoperation in their first year compared to women who went with the laparoscopic sterilization minimal invasive surgery. Plus, this is not the first time that Essure has gone under scrutiny since the FDA first approved it in 2002.
The safety of the device was reviewed by the FDA in September, 2015 after complaints were received of complications experienced by users. The biggest side effect that was reported to the FDA by women was abdominal pain; the second was heavy menstrual periods.
The study, co-authored by Dr. Art Sedrakyan, Weill Cornell Medical College and New York Presbyterian Hospital’s Healthcare Policy’s professor, focuses on the need for reoperations after the use of Essure. It was estimated that over 10,000 patients who used Essure required a reoperation over the past few years.
Other injuries experienced after the implant procedure include allergic reactions to the nickel in the implant, serious pelvic pain and other post-operations that included stabilizing the device after it shifted inappropriately and hysterectomies.
Although Bayer boasts the device to be a highly percent effective and non-invasive type of permanent birth control which has a quick recovery time, there are thousands of women who would argue differently. These women state their lives were ruined by this device and they suffered permanent injuries because of it. Their injuries included perforated organs, autoimmune diseases, and severe pelvic pain. Over 5,000 reports were received by the FDA since 2002 about Essure and many of these reports took place after Bayer took over.
Several women filed lawsuits against Bayer after these adverse events.
Heather Walsh vs. Bayer Corporation
One particular lawsuit on file involving the Essure implant was filed by plaintiff Heather Walsh, who says that because the FDA’s conditional premarket approval (CPMA) of Essure is invalid, federal preemption shouldn’t apply to her case.
She also says the conditions of the CPMA were not adhered to by Bayer since they neglected to meet the requirements of the FDA and manufactured Essure at a facility that was not licensed, among other things. She claims in her suit that Essure is ‘misbranded’ and ‘adulterated’ and shouldn’t have ever been sold in accordant to federal law.
Although it is not clear how this suit will resolve or if other women who were affected by Essure will be able to file their own lawsuits, there are attorneys out there who are ready to work on the behalf of women injured by Essure. These lawyers are aiming to be proactive in developing a strategy and talking with women about their challenges of their individual cases and inform them of what their legal options are. Hopefully, they will be able to bring recourse to all the women who were ever injured by the Essure system.
Know Your Essure Injury Legal Rights
The only way for women to recoup their losses resulting from the expensive treatments endured for complications of Essure, is to file a lawsuit. Whether Bayer does or does not feel responsible for the patients’ injuries resulting from use of Essure, the fact of the matter is the company still manufactured the drug that caused these injuries and should be held accountable for them. Pharmaceutical companies are required by the FDA to warn their consumers of all possible dangers associated with their products, and in the eyes of thousands of women, Bayer was not transparent in how they marketed Essure.
Have you suffered any Essure-related injuries or have had to go back and have a reoperation because of a complication with Essure? If so, you could be able to file a lawsuit. An attorney can sit down with you to consult your case, inform you of your legal rights and guide you through the process of a claim.