The adverse effects of Essure have become a major concern to the medical community and patient population, with numerous women reporting varying injuries ranging from severe pain to allergic reactions.
Ever since the device’s approval in 2002, the FDA has received over 5,000 reports injury reports indicating adverse effects of Essure.
When the device was released by Bayer HealthCare, the product quickly became popular. But the company allegedly underestimated the severity of the potential adverse effects of Essure.
In some cases, women reported the Essure coils migrated away from their implant site and had even perforated nearby organs.
Neurological damage has also been reported, with some patients reporting severe headaches or migraines. In addition, some Essure coils have broken apart or fractured soon after implantation and fragments had spread.
Furthermore, some women who received the Essure coils had suffered from allergic reactions because of sensitivity to nickel. The thousands reports of adverse effects of Essure have included, but are not limited to:
- Abdominal pain
- Headache
- Dizziness or fainting
- Back pain
- Pain in arms and legs
- Vomiting
- Bloating
- Cramps
- Vaginal infection and discharge
- Unexpected menstruation
- Fatigue
- Changes in body weight
- Painful intercourse
- Allergic reactions
- Autoimmune complications
These Essure complications often forced patients to undergo explantation surgery to remove the device. However due to the sensitive nature of the implant site, women often sustain damage to their uterus or fallopian tubes. In the most severe cases, a hysterectomy may be needed to completely resolve Essure complications.
Overview of Essure Adverse Effects Concern
Originally developed by Conceptus Inc. and later acquired by Bayer HealthCare, the Essure birth control device quickly gained traction as the only non surgical form of female sterilization available in the United States.
The device is touted to be safer, less invasive and more convenient than traditional tubal ligation, which attracted numerous women who were seeking permanent sterilization. The device consists of two metal coils, each of which are implanted in each fallopian tube to prevent sperm to egg fertilization.
After the coils are implanted in the fallopian tubes, the tissue eventually swells around the coils and prevents pregnancy. Approximately 750,000 women have opted to have the Essure birth control implanted after reviewing Bayer’s marketing materials and encouraged by the overall convenience the device provided.
However numerous women have reported adverse effects of Essure, with consumer advocates stating the product never should have been released onto the market. Consumer advocate Erin Brockovich helped lead a campaign to remove the Essure birth control device from the market, stating the FDA never should have approved the device to go to market.
However, different health officials have contended that the device should remain on the market, as it is a safe and effective alternative to surgical female sterilization. Bayer HealthCare has been criticized for failing to warn the public against the potential adverse effects of Essure, and is currently facing intense legal action.
Bayer is facing legal action for negligence and failure to warn from numerous women claiming the company either knew or should have known about potential Essure complications. Potential claimants should contact a lawyer to determine eligibility for an Essure lawsuit.
In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. Hurry — statutes of limitations may apply.
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