Firm-Wide blog

Fetal Deaths Linked to Bayer’s Essure Contraceptive Device

By Burg Simpson
February 19, 2016
2 min read

Reuters reports that Device Events, a private company specializing in medical device adverse events, analyzed the reports of fetal death with the contraceptive device Essure.   The results reported by Madris Tomes, founder and CEO of Device Events, states that she has found 303 fetal deaths linked to Essure. This number is substantially higher than the mere 5 fetal deaths the U.S. Food and Drug Administration (FDA) has previously cited.

Essure is a permanent contraceptive device developed by Conceptus Inc., a subsidiary of Bayer AG. to be a less invasive alternative to tubal ligation. As with all contraceptive devices and drugs, there is a risk that pregnancy may still occur. However, Madris Tomes’ analysis shows that if a woman, using an Essure device, does become pregnant the fetus is at a much greater risk than previously identified. Ms. Tomes found these additional reports by conducting a more in-depth look at the FDA’s adverse event reporting database. Using specific keywords such as “still born” and “miscarriage,” rather than relying merely on general boxes checked on the adverse event form indicating broad events such as “death” or “injury,” she was able to locate the additional reports.

Bayer maintains that the roughly 750,000 units that have been sold are safe and effective. However, the FDA will decide what additional action, such as a product label change or further studies, may be needed.

If you or a loved one suffered injuries that you believe were caused by Bayer AG’s contraceptive device Essure, contact one of the experienced dangerous medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today

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