Essure Birth Control Device
Essure has positioned itself in the contraception market as the only form of permanent birth control for women that does not require a medical procedure, such as a tubal ligation. Instead, small coils made out of a nickel-titanium alloy are inserted into each fallopian tube by a doctor, typically in under 15 minutes. Over a period of three to six months, scar tissue grows around the coils, forming a barrier that prevents sperm from reaching and fertilizing an egg. The manufacturer boasts a success rate of more than 99 percent in preventing pregnancy.
Adverse Effects of the Essure Device
Thousands of women have reported myriad negative side effects to the Food and Drug Administration, including perforated fallopian tubes, abdominal pain, heavy menstrual cycles, and unintended pregnancies. The FDA obtained nearly 10,000 medical-device reports related to Essure from the 13 years it has been on the market. Of the 9,900 reports submitted to the FDA, just under 7,000 women cited pain/abdominal pain; there were 3,200 reports of heavier/irregular periods; 3,000 reports of headaches; and about 2,200 complaints of fatigue. There were also reports of patient-device incompatibility; migration of the device; device breakage; difficulty with insertion and removal; and 631 reports of pregnancy, nearly half of which resulted in pregnancy loss.
Bayer to Discontinue the Sale of Essure
The FDA approved Essure, manufactured by Bayer HeathCare Pharmaceuticals, in 2002 following a fast-track review process. As a permanent method of birth control, it is intended to remain in place for life — so extra caution should have been exercised, particularly as complaints began to accumulate. The safety trials were plagued with problems: Sample sizes were small. Women who were fitted with the device were followed for less than five years. A long-term study omitted results from a third of the participants. Worse still, Bayer refuses to say how many women in the United States use the device, making it difficult to analyze the complaints in a broader perspective.
In the wake of still more problems, in February 2016 the FDA ordered Bayer to perform further safety studies, as well as requiring the company to include a so-called “black box” warning on or contained within its packaging. A black-box warning is the strongest the FDA can impose, meant to signal the severity of risks associated with a drug or device.
In July of 2018 Bayer announced that it will discontinue the sale of Essure in the United States by the end of 2018.
Many lawsuits have been filed on behalf of those who have suffered from complications related to this device. Filing a lawsuit is often necessary to maximize the settlement value of a case. Many of the lawsuits claim that Bayer failed to report the side effects associated with the device. The effect of Bayers recent decision to discontinue the sale of Essure remains to be seen, with Bayer claiming it was strictly a business decision.
Experienced Essure Attorney
The Dysart Law Firm P.C. is committed to helping those who have been injured due to the Essure birth control device. We have fought some of the world’s largest corporations to obtain compensation for victims. If you or a loved one have been injured due to Essure contact us today at 888.586.7041.