Bayer released a statement this morning saying, “The concerns about Essure are based primarily on anecdotal reports from individual patients.” This is simply untrue; reports from physicians nearly DOUBLED after the FDA safety hearing, and many reports are from other medical professionals as well. Perhaps if Conceptus/Bayer had listened to the clinical trial participants’ “anecdotal reports” of problems from the very beginning instead of interpreting these answers to fit their agenda (product approval), they wouldn’t be in a situation with thousands of harmed women, a black box warning, FDA restrictions, and diminishing sales.
Further, the women who ARE self-reporting have more than anecdotal evidence. They have operative reports showing perforations, migrations, eroding fallopian tubes, and other pathologies. Rest assured that 17,000+ legal complaints aren’t filed based on “anecdotal evidence” alone!
Bayer has also chosen to cite “declining sales” as their motivation for discontinuing Essure but insists they will maintain their PMA status. In the meantime, they are eagerly using this as an opportunity to scale back an already anemic 3-year post-market study that would have directly compared Essure to the standard for female sterilization, a traditional tubal ligation. We already have numerous pre-market studies that were limited in scope. We don’t need yet another one managed by Bayer, with their built-in confirmation biases.
Further, the clip Bayer is trying to discredit speaks for itself. The panel member asked what would happen if they approved Essure despite any misgivings previously mentioned at that meeting, and someone else “jokingly” replied that PIs would track all of them down later, presumably to hold them accountable. The fact that someone even posed that question as part of an on-record statement indicated they had concerns about the device and the consequences of approving it despite those concerns. This was not a fabricated clip; it was from the official video of the approval meeting, and implying Mr. Dick somehow sensationalized this speaks to the integrity of Bayer. There were also equally disturbing clips from the panel meeting not mentioned in the film. When the issue of sensitivity to the metals in Essure was brought up, one expert responded: “I don’t know what happens to people with metal sensitivity when you implant metals in them.” Another expert joked that the only metal she was not sensitive to was “14k (laughter)” and “18k” gold. It didn't stop there. In fact, the Chair of the meeting offended all women from the midwest when he referred to the Essure patient population in Iowa as “those corn fed girls.”
Finally, Bayer has repeatedly feigned concern for asymptomatic women rushing into unnecessary removal surgery, stating they are being pressured with “misinformation” into “unnecessary” hysterectomies . Any surgeries related to Essure have been conducted by certified, credentialed, and experienced surgeons and doctors. Physicians generally do not conduct complicated, risky, and unnecessary surgeries simply because a patient demands it, particularly if they do not think it is an appropriate and necessary treatment. Clearly, many doctors DO feel a surgery to remove Essure is necessary for the health of some women with debilitating side effects and adverse events, such as allergies, migrations, perforations, and hyperimmune reactions. Thus, Bayer’s statements directly maligns physicians who performed these necessary surgeries on their patients, but this isn’t unexpected. They have a clear pattern of blaming physicians AND patients for any problems with Essure, especially those brave enough to speak publicly about issues with the product.
We'll leave it up to the courts to decide the truth.