Essure implants, a form of birth control designed by a subsidiary of Bayer AG, was designed to help women avoid the physical trauma of “having your tubes tied,” also known as tubal ligation. However, this product may not be a safe alternative after all, as there may be serious and life-changing side effects associated with Essure. Here’s what women need to know about how Essure may affect them and how to get help.
What Is Essure?
The Essure Permanent Birth Control System consists of two small, implantable devices made to be inserted into the fallopian tubes. The flexible plastic-and-metal implant is placed via a catheter that passes from the vagina, through the cervix, and into the uterus, where it is then placed into the fallopian tubes. The device is designed to encourage scar tissue to form at the implant sites, preventing eggs from passing into the uterus during ovulation. The Essure insertion procedure may be performed in a regular doctor’s office in minutes, unlike a tubal ligation, which must be performed in an operating room while under anesthesia.
What Side Effects Can Essure Cause?
Though billed as a convenient alternative to ligation, Essure implantation isn’t without risks. According to the U.S. Food and Drug Administration (FDA), clinical trials indicated that women who receive the implant may suffer the following Essure side effects:
- Back, pelvic, or abdominal pain
- Device migration into the pelvic or abdominal cavities
- Organ perforation (tears or punctures) of the uterus or fallopian tubes
- Headaches, fatigue, or weakness
- Joint pain
- Hair loss
Some women also reported allergic reactions, some of which may be caused by the composition of the implant, which contains the metal nickel. Hair loss and mood changes or depression were also reported in clinical trials, and other women have suffered from miscarriages, autoimmune disorders, tumors, and abscesses in their bodies. Some women have died.
In a five-year post-approval study of women who received Essure implants, the FDA reported that as many as 9 percent of women experienced “adverse events” after the procedure. The events reported in the study included reports of:
- Painful periods or ovulation
- Changes in menstruation
- Expulsion of the device
- Unsatisfactory device location
- Micro-fragments of the implant retained in the body
This study also found that women complained of back pain, abdominal pain or camps, and pain during intercourse. Another study published in the British Medical Journal found that women who received Essure were at as much as ten times the risk of requiring a second surgery, compared to women who received a laparoscopic sterilization.
More studies are planned, including a seven-year follow-up—but that will not be completed until 2023.
How Women Are Seeking Relief From Essure
As more and more women have come forward after suffering side effects or complications of the Essure Permanent Birth Control System, thousands are choosing to file lawsuits against Bayer. The lawsuits allege that the company failed to warn patients or notify the FDA of the potentially dangerous problems with its product, despite receiving over 30,000 complaints of injury since Essure was released in 2002.
Some families are choosing to file suit, as well, claiming wrongful death of a loved one caused by the implant, as well as claims of medical malpractice and negligence. The company has claimed federal preemption rules protect them from lawsuits since the device is FDA approved, but in 2016, courts in both Pennsylvania and California have allowed multiple claims to proceed.
Get Legal Help Today
If you’ve suffered harm or lost a loved one due to an Essure implant, you may be able to seek compensation in a court of law for medical bills, repeated surgery, lost time and wages, pain and suffering, and more. Wayne Wright LLP is a nationally recognized Texas law firm with experience handling defective medical device claims, and we’re here to help you. Call us by phone, use the live chat box, or click the contact link on this page for a free, no-obligation consultation with a legal professional about your Essure legal situation today.