There’s more bad news to report on the use of Essure, a meant-to-be permanent form of birth control made by Bayer. There’s data to suggest that the U.S. Food and Drug Administration (FDA) greatly underestimated the amount of fetal deaths related to the device.
Whistle Blower Uncovers Fetal Death Data
Madris Tomes is the founder of Device Events, an organization focused on the medical device market – specifically wading through large volumes of data for safety verification. According to her, while the FDA previously reported five cases of fetal deaths related to Essure use, the actual number is 303. That’s quite a discrepancy.
Tomes poured through over 10,000 cases related to Essure, and found that many contained reports that made note of “injuries,” “malfunctions” and “miscarriages.” The number of fetal deaths claimed by the FDA was based merely on a search of records using the key term “deaths.”
In February, Pennsylvania Congressman Mike Fitzpatrick – who introduced a bill for the removal of the FDA’s approval for Essure in November – brought Tomes’s findings to the attention of the FDA. In his message, Fitzpatrick said, “The FDA either has data they’re not paying attention to or they’ve got defective systems in place to analyze the data.”
History of Problems with Essure
As we wrote in an earlier blog entry, Essure has been absolutely pummeled by concerns about its safety for women. Made of two metal coils, the device blocks the passage of sperm to the egg after being inserted into a woman’s fallopian tubes.
As of last July, over 5,000 women had filed complaints with the FDA over serious effects from Essure – including severe pain, miscarriages and other injuries.
In early March, the FDA required Bayer to include a special black box warning to Essure packaging and to conduct a clinical study to gather as much data as possible about health risks associated with the device. For the study, Bayer is required to monitor the health of more than 2,000 women for at least three years.
There also seems to be a significant problem with securing the Essure device after its inserted. Studies have indicated that the failure rate of Essure placement can top 12 percent – an exceedingly high rate of failure for a device that has been approved by the FDA.
OUR ADVICE FOR ESSURE USERS
We encourage you to bookmark and subscribe to this blog as we’ll continue to monitor the news about Essure. If you have used Essure and have suffered health complications, we strongly encourage you to contact an attorney specializing in personal injury lawsuits.