Tubal ligation has been in use for over a century as a permanent sterilization method but wasn’t widely available until the 1960s. Prior to the 60s, a woman could only be sterilized if a doctor allowed it because her life would be in danger from childbearing. With tubal ligation, the doctor makes two small abdominal incisions, then closes the fallopian tubes by cutting, cauterizing, or using rings or clips to bind a section of the tubes.
In 2002, a new method of permanent sterilization received FDA approval. With Essure tubal sterilization, a small coil is inserted into each fallopian tube and, after three months or longer, the scar tissue that grows around these coils should be thick enough to completely block the tube and prevent an egg from passing through and being fertilized.
As with any medical procedure, things can go wrong. One of the risks is unwanted pregnancy despite the procedure, with a higher risk of ectopic pregnancy (where the fetus is growing inside a fallopian tube). Studies that compared tubal ligation to Essure showed that tubal ligation is far more reliable in preventing pregnancy.
In addition to a higher risk of pregnancy, at least 17,000 women (around one in four) have complained of a wide range of serious injuries which, for many women, began as soon as the coils were implanted. While some women have complained of problems with tubal ligation, these problems are mainly linked to medical malpractice and not to failure of or injury from the birth control method itself.
Essure Problems Reported to the FDA
According to the Food and Drug Administration website, they have received 9,900 Essure medical device reports on their Manufacturer and User Facility Device Experience (MAUDE) website. These reports were submitted between 2002, when Essure was approved for marketing, and December 31, 2015. When we take into account that Bayer claims to have sold 75,000 Essure implants worldwide and people from other countries do not report adverse events on the U.S. FDA website, the statistics of over one in eight women having a serious problem from Essure are far below what is really going on.
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Essure Is New Compared to Tubal Ligation
Comparatively speaking, Essure is a new method of tubal sterilization. However, although Essure is new, it was approved using the stricter FDA standards for Class III medical devices. Conceptus, the company that first developed and marketed Essure, may have cheated in gaining FDA approval for marketing. After thousands of recent complaints about the Essure implant, clinical trial subjects have come forward to allege that some of the answers they gave to the questions in the clinical trial were changed.
Is Laparoscopic Tubal Ligation Safer Than Essure?
Tubal Ligation has been in use for decades. The main difference that supports claims that Essure is better is the procedure itself. Tubal ligation involves a minor surgery with incisions made into the abdomen while Essure coils are inserted without surgery. This allowed the company to say that Essure is a noninvasive method of permanent birth control. However, it takes surgery to get the coils out if they cause problems. Doctors have had difficulty removing the coils, particularly if a coil has broken into pieces or disappeared completely. Also, there’s significantly greater risk of getting pregnant after Essure than after tubal ligation.
Though both Bayer and the FDA continue to maintain that Essure is safe and effective for most women, one out of four women have reported serious problems with Essure. If the company changed the answers subjects gave in clinical trials, FDA approval may not be an accurate reflection of whether Essure is safe to use and what the possible risks are. The FDA also added a physician checklist of questions to ask a woman when deciding whether Essure is a good choice. By signing the checklist a woman acknowledges she’s been warned of possible problems. Ultimately you have to decide which birth control method is right for you. If you elect to have Essure coils implanted in your body, you may be gambling with your health, and after signing a release checklist, it could be difficult to recover damages for Essure injuries.
Call Isaacs & Isaacs Essure Lawsuit Attorneys
If you have suffered serious injury from Essure permanent birth control implants, we will help you to recover the just compensation you deserve and need to move forward and rebuild your life. Call 800-800-8888 now or fill out our form to speak with an seasoned, compassionate and aggressive Isaacs & Isaacs attorney about your claim. We have 99-percent success in recovering maximum damages for injury victims.