January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.
Bayer says that patient safety is a top priority. Seriously?
On November 16, 2016, after conducting a lengthy Advisory Committee hearing, the FDA required Bayer to issue a black box warning that listed perforation of the uterus and/or fallopian tubes and movement of the inserts into the abdominal or pelvic cavity. The black box warning also said that in the event of one of these adverse events, a yet to be described surgical procedure will be required. Before this change in Bayer’s Essure® labeling, its warnings to women considering Essure® were misleading. Even after these changes, the Essure® warnings are still misleading.
The FDA requires that the labeling of a medical device must not be false or misleading . Significantly, Bayer can add or strengthen a warning or adverse reaction . A warning can be misleading by failing to advise a user of all important risks. So why not tell women who are considering Essure® all of the risks, including:
When the Essure® insert pokes through the fallopian tubes or uterus, or when it moves out of place and into the uterus, peritoneal cavity or bowel, it becomes ineffective to prevent pregnancy. That is when Essure® can cause fetal deaths.
There have been reports of fetal deaths as a result of Essure®. It has been reported that when Essure® inserts became dislodged the pointed tip of the insert ruptured the placenta or the amniotic sac. This leads to placental abruption, premature delivery, and the death of the baby. In adverse event reports, Bayer has even recognized that fetal death is not listed in its safety information. But Bayer has done nothing to warn doctors and women of this risk. Fetal death is most certainly a risk that most women would seriously consider before they agreed to the Essure® procedure.
A study at Cornell’s Weill Medical College has confirmed that women undergoing Essure® procedures have more than a ten-fold risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization . Another study at the Advanced Center for Genetics at Carlsbad, California, in conjunction with other medical centers, has found that the predominant surgical answer to Essure® complaints is a hysterectomy for many women .
Bayer sells Essure® as a “gentle procedure”; that it is “without cutting”; that can be done “without going under general anesthesia”; and that can be done in “about 13 minutes”.
Why not tell women that their chances of having a reoperation is 10 times what it would be with a laparoscopic procedure? And, how about letting them know that the reoperation may very well be a hysterectomy that will remove their uterus, fallopian tubes and ovaries.
A hysterectomy will require surgery under general anesthesia; a 2-4 day hospital stay and a recuperative period of about 2-6 weeks to even return to normal activities. Does Bayer think that information might be informative to women evaluating the risks of Essure®? Apparently not, because none of this important data regarding the risk of a serious operation can be found in Bayer’s black box warning.
This Missing Information Harms Patients
Omission of important information regarding risks can make a “warning” label ineffective and misleading. The risks of fetal deaths and hysterectomies are certainly important to women considering the risks involved in Essure® and should be contained in Bayer’s warning label if Bayer really is putting patient safety first. Bayer’s Essure® warnings were misleading before the FDA-mandated black box change on November 16, 2016. And, Bayer’s Essure® warnings are still misleading. These misleading Essure® labels continue to put women at risk of harm.
Fleming, Nolen & Jez is a law firm representing numerous women who have suffered due to the Essure® device. Requests for information regarding Essure® or this blog can be made by calling us at (713) 621-7944 or by filling out our online form.
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 21 CFR § 352(a)
 21 CFS § 314.70(6)(iii)(a)-(d)
 “Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study”; Jialin Mao, Samantha Pfeifer, Peter Schlegel, Art Sedrakyan; BMJ, 2015
 “Analysis of surgeries performed after hysteroscopic sterilization as tabulated from 3,803 Essure patient experiences”; E. Scott Sills, Xiang Li, Samuel H. Wood, Christopher A. Jones; Obstetrics & Gynecology Science, 2017