Essure®, introduced by Bayer as a method of permanent birth control for women, was pulled from shelves at the end of December 2018 due to complaints about the device’s side effects. The FDA has been monitoring the product since 2015 after patient reports signaled a possible cause for worry. To ensure that all patients were fully informed about the risk of using Essure®, the agency introduced restrictions on who could sell the device and required warnings on its packaging. When sales dropped, Bayer decided to discontinue sales of the devices; the company requests that any not implanted by 2019 be returned to the company.
Sold as a New Birth Control Option, Essure® Let Women Down
Essure was released in 2002 as a new method of permanent birth control that was more than 99% effective. The device consisted of metal coils that were designed to inflame the fallopian tubes, creating a barrier of scar tissue across them. In most cases, it was successful at preventing unwanted pregnancy. However, that success came at a price.
Though Essure® patients only saw pregnancies at a rate of 1.5 per 1,000, the device had other problems. Some women reported that it didn’t stay in their fallopian tubes but found its way to other parts to other parts of the abdomen or pelvic cavity. The coils could also pierce patient’s uterus or fallopian tubes and could damage the colon or bladder if it did so. In these cases, the device had to be removed surgically; some women also needed additional surgical interventions to repair the damage done by the device. Hysterectomy (removal of the uterus) or salpingectomy (removal of the fallopian tubes) were two common responses to this scenario.
Additional Care Required
Though Essure® was marketed as a surgery-free alternative to tubal ligation (or “getting your tubes tied”), a study from Cornell Medicine found that women who used the device were ten times more likely to need follow-up surgery than those who opted for tubal ligation. Worse, the women who found themselves in the hospital often had surgeries that were riskier than their peers who hadn’t tried Essure®. The product appealed to many women because it had been marketed as permanent—but when things went wrong, they experienced the downside of using device not meant to be removed.
Dangerous Side Effects
The device could cause allergic reactions included itching or hives, Bayer warned on the packaging: Many people are allergic to nickel, which was one of the main components in the coils. Some women did indeed experience these side effects, but they had other concerns, too. A host of patients reported issues including:
- Mood Disorders like Depression
- Weight Gain
- Autoimmune Disorders (Lupus, Chronic Fatigue Syndrome, Rheumatoid Arthritis)
- Hair Loss
- Ectopic Pregnancy
- Pelvic Pain
- Heavy or Irregular Periods, Spotting
Over 26,000 reports of side effects reached the FDA between 2002 and 2017; in that time, 48 women died from complications of Essure®. To gather more data on how these issues were related to use of the device, the FDA commissioned a further study from Bayer on the side effects of the device.
Are You an Essure® User with Severe Side Effects?
Our team at Bertram & Graf, L.L.C., stands with the over 20,000 women who have suffered side effects after an Essure® implant. By releasing a product without sufficient testing, Bayer endangered women who were looking for a safer alternative to tubal ligation. Many patients had to undergo more surgeries or deal with painful side effects of a device they were told was safe. We are here to help you hold Bayer accountable if Essure® has changed your quality of life or necessitated additional care that you weren’t expecting. Medical bills and other costs from your hardships can add up quickly. You may be entitled to compensation if you experienced serious complications after choosing Essure®.
Contact our experienced team online or call (888) 398-2277 to discuss your Essure® case with us today. There is help.