In response to the recent protest by patients harmed by Essure, Bayer’s birth control device, Bayer’s statement saying their “greatest priority” is patient safety is disingenuous and self-serving.
If Bayer truly cared about women’s safety, they would remove Essure from the market. Period.
Instead, Bayer opted to trot out several of its time-worn statements:
“…our greatest priority is ensuring patient safety and the proper use of our products” and “[an] extensive body of scientific evidence establishes that Essure is comparable in safety and effectiveness to tubal ligation.”
The truth is, Bayer has falsely marketed Essure’s effectiveness and safety data, and as a result, tens of thousands of women around the world have suffered complications ranging from unintended pregnancy to having hysterectomy to have the device removed. Bayer need look no further than their own records and the FDA’s database for this evidence.
In a January 2018 JAMA study, which addressed medical outcomes following hysteroscopic sterilization, i.e., Essure, compared to tubal ligation, the study found that: “The risk of so-called ‘gynecological complications’—predominantly a need for another sterilization procedure within a year—is well known to be higher with hysteroscopic sterilization (Essure) compared to laparoscopic sterilization.”
Essure was approved under an “expedited review” without randomized controlled trials, using two nonrandomized, nonblinded, prospective studies that lacked a comparator group, enrolled a total of 926 women, and only followed them for 18 months, even though Essure is supposed to remain in place for a woman’s lifetime.
And Bayer’s post-market surveillance of Essure is far from robust. For example, in one post-approval study, 30 percent of the original study group could not be followed for the full five years, so the data is misleading and incomplete.
The only constructive thing Bayer has said regarding Essure is that they “encourage women who have questions or concerns about Essure to seek proper medical advice from an experienced, board-certified Obstetrician-Gynecologist.”
We did exactly that. Board-certified Obstetrician-Gynecologist Dr. E. Scott Sills says when it comes to Essure, he’s seen a range of side effects, many very dangerous.
“Patients were gaining weight, they were having abdominal bloating, painful sex, they were having irregular bleeding,” Sills told us. “They were having skin problems, hair loss, fatigue… They (Essure devices) puncture the fallopian tube and get into the abdominal cavity and snag the fallopian tube and go up to the liver… I’ve seen this happen in my practice.”
All these harms and more are documented in our film The Bleeding Edge, which will premiere on Netflix July 27, so viewers can learn the real truth about Essure.
The more you know, the less you trust Bayer.