The U.S. Food and Drug Administration has announced that the permanent contraceptive device Essure will receive a “black box label” following complaints of dangerous side effects from thousands of affected women. The device, which is manufactured and marketed by Bayer, is now linked to serious health complications, including life-threatening pregnancies and stillbirths.
Essure is a small coil that is inserted in the fallopian tubes of the patient. As scar tissue forms around the coil, it blocks sperm from reaching the egg. However, many patients have reported a number of severe effects of the device—which has shown it is not 100% effective in preventing pregnancy.
Adverse effects linked to Essure include:
- Severe pain
- Bleeding
- Miscarriages
- Stillbirths
- Pronounced pregnancy complications
“Life-Threatening Risks”
According to the FDA, the black box label is meant to “call attention to serious or life-threatening risks” associated with the product.” The agency has also ordered Bayer to conduct a new study to “determine what, if any, further actions related to Essure are needed to protect public health.” The plans of that three-year study are due to the FDA by the end of this month.
Bayer has also responded to the black box label order, saying: “Essure is an important permanent birth control option with a positive benefit-risk profile. Bayer will continue to work closely with the FDA to support the continued safe, effective and appropriate use of Essure.”
Previously, Bayer claimed that Essure was 99% effective and is blaming “patient error” for unintended pregnancies. The black box label—which will have language that is still being informed by patient and corporate feedback—will start to appear on the Essure packaging at the end of April 2016.
If you or a loved one has suffered adverse effects due to the Essure device, then you may have grounds to seek compensation. Regulators are still trying to determine whether Bayer did their diligence on determining the risks associated with their product before putting it on the market—and their insistence that pregnancies have been caused by patient error is dismissive of the thousands of women that have suffered due to their product.
At Adler & Manson, our experienced Kansas City lawyers know that big companies like Bayer like to deflect blame and protect their bottom lines. Our dedicated advocates are ready to hear your Essure story and, if appropriate, start taking aggressive steps toward helping you recover the compensation you are entitled to.
Start exploring your options by calling us at (816) 333-0400 today.