The FDA recently reevaluated its position on the sterilization device Essure. This birth control product is a metal coil system placed in the fallopian tubes to prevent egg fertilization. It was intended as a safe and permanent form of birth control for women who were finished having children, with the manufacturer citing a nearly 100 percent effectiveness rate.
Birth Control Device Essure Linked to Serious Medical Problems
The actual implantation of Essure does not require surgery. Instead, a doctor inserts the flexible metal coils of the device through the vagina, into the fallopian tubes. These tubes move eggs from the ovaries into the uterus. It takes approximately three months for tissue to grow around the coils, thus preventing sperm from gaining access to eggs and preventing conception. Women must return for an X-ray after the three-month period to confirm complete blockage of their tubes.
FDA Reconsiders its Premarket Approval of Essure
Complications have arisen with the device, including expulsion, organ perforation and migration within the abdomen. Until recently, the product was granted premarket approval by the FDA. However, in light of the number of women having issues with Essure, the FDA has reconsidered and the floor is now open for litigation.
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Common Conditions Linked to Essure
Thousands of women have been affected by conditions caused by the Essure device. These include:
- Perforated uterus or fallopian tubes
- Intense pelvic pain
- Autoimmune diseases
- Allergic reactions
- Abnormal bleeding
- Chronic fatigue
- Bowel problems
- Uterine or ovarian cysts
- Uterine fibroids
- Urinary tract infections
- Sexual dysfunction
- Frequent headaches
- Cardiac issues
- High blood pressure
- Blood clots
- Thyroid disease
There are reports of women experiencing gastrointestinal disorders and chronic pain in various parts of the body because of the Essure device. If the device has migrated, adhesions may occur, causing organs in the body stick to one another. These adhesions usually involve digestive organs, and the scar tissue makes digestion difficult and painful. Virtually every organ and bodily system has the potential to be affected by the Essure coil.
Essure-Use May Increase Risk of Ectopic Pregnancy
Many women have required surgery, including hysterectomy, to either save their lives or stop the severe, ongoing pain. The coils have not only perforated other organs, but have become embedded in them. Since Essure is intended as a permanent device, many women have had to undergo surgery to have it removed after experiencing complications. Other women have gotten pregnant because the device either migrated or otherwise failed. Many of these pregnancies are ectopic, meaning the fertilized egg is implanted in the fallopian tubes and never migrates to the uterus. It is not possible for the embryo to survive, but its growth in the tube threatens the life of the mother without prompt medical attention.
If you or a loved one has suffered complications stemming from Essure, contact the Goldwater Law Firm today. Our attorneys will evaluate the case details and make sure you understand your rights and options before moving forward as part of an Essure lawsuit. To schedule a consultation with one of our practicing attorneys, please give us a call at 1-800-210-9700 or complete our inquiry contact form.