Essure Manufacturer Issues Warnings About Its Birth Control Implant
Some women may face the difficult choice of whether or not to undergo surgical sterilization for permanent birth control. For these patients, the Essure implant may seem like perfect alternative, as it prevents pregnancy without the need for surgery. However, the device is not without its risks, including the potential for unwanted pregnancy. The manufacturer of the device has issued several warnings about the Essure birth control method to help women decide if the implant is right for them.
What Is the Essure Implant?
Essure was created by Bayer HealthCare Pharmaceuticals, Inc., and approved by the FDA
in 2002. The device is a coil of mesh wire that a physician inserts into each fallopian tube. As weeks pass after implantation, scar tissue builds up along the device, preventing sperm from reaching the egg. Essure inserts are a permanent form of birth control that doesn’t require surgery and doesn’t release any hormones into the body. Implantation typically takes less than 20 minutes and requires about a day of recovery time.
Not all women are ideal candidates for the Essure system. For instance, women under 21 or over 45 are advised against Essure, as the safety and effectiveness of the device has not been properly tested in these patients. Additionally, women shouldn’t use Essure if they:
- Are (or may be) pregnant
- Have been pregnant within the past 6 weeks
- Have undergone tubal ligation surgery
- Have only one fallopian tube
- Have one or both of their fallopian tubes obstructed
- Have an allergy to contrast dye
- Aren’t sure about permanent birth control
- Recently had a pelvic infection
- Are currently in the second half of their regular menstrual cycle
- Are taking medications or therapies that can suppress the immune system (such as chemotherapy)
- Have a nickel allergy
- Can’t tolerate or undergo an x-ray, as the Essure Confirmation Test requires an x-ray to ensure the device was placed properly
Risks of Essure Implants Include Unintended Pregnancy
In addition to the potentially harmful side effects of the Essure device, women are advised that accidental pregnancy is possible within the first three months after device implantation. Patients are told to take an alternate method of birth control for three-to-six months after the proceedure to allow scar tissue to build along the coil. Women taking oral birth control are advised to continue taking their prescriptions during this time, while women with intrauterine devices need to switch to another method.
Bayer has acknowledged many risks of the Essure system, including:
- Breakage. If a piece of the insert breaks off after implantation, a doctor may remove the piece or allow it to be expelled during the next menstrual cycle.
- Punctures. The insert could puncture a fallopian tube or perforate the surrounding tissues, requiring surgical repair.
- Expulsion. The device may be unexpectedly expelled from the body.
- Migration. If the insert moves out of places and migrates into the abdomen, it may need surgical removal.
- Allergic reactions. The Essure device is made from a nickel-titanium alloy, and trace amounts of nickel may be released into the body after insertion. Patients who experience rashes, itching, or hives may be allergic to to nickel.
- Ectopic pregnancy. Women using Essure are more likely to have an ectopic pregnancy, which is a pregnancy that outside of the uterus.
- Pain. Women may experience adverse symptoms after implantation, including pain, nausea, vomiting or fainting. Some patients may suffer mild to moderate cramping, vaginal bleeding, and pelvic or back pain, while others have reported chronic pelvic pain as a result of the device.
- Fertilization risks. Bayer has warned that the risks to a patient and her fetus if pregnancy occurs after Essure implantation are not known. These warnings regarding safety and effectiveness also applies to in vitro fertilization after the Essure procedure.
- Hysterectomies. The company acknowledges that the safety and effectiveness of reversing the Essure procedure are not known, leaving many patients little choice but to remove the entire fallopian tube, affected ovary, or the uterus in order to rid themselves of the Essure coil.
If you or someone you love has suffered a severe injury as a result of an Essure implant, we can help. The McGartland Law Firm provides nationwide legal representation for victims of defective medical devices, and we don’t charge legal fees unless we win your case. Call the number on this page today or use our convenient contact form to speak with one of our representatives.