Dear Commissioner Gottlieb:

While we applaud on many levels Bayer’s announcement concerning the phasing out of Essure sales in the United States, we have very real and valid concerns regarding the continued marketing and use of this device, particularly as Bayer and physicians scramble to unload their current inventories into unsuspecting women. At this time we have documented multiple cases where women still are not being given the mandated black box warning or the patient checklist. In fact some are being asked not to google Essure due to “fake news.” These actions are in direct violation of the FDA’s April 9, 2018 mandates.

Additionally, we continue to see outdated marketing materials with false and misleading information in our doctors’ offices. The FDA’s April 9, 2018 correspondence to Bayer specifically stated that the sale and distribution of Essure was restricted until the labeling specified the specific training or experience practitioners need in order to use the device. We do not believe the package labeling has been updated to reflect these changes. Furthermore, the FDA required that all labeling and advertising for Essure must include the following: “The sale and distribution by of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling to be provided by Bayer.” It is blatantly apparent that the labeling and advertising updates have not been instituted nor is it reasonable to believe that Bayer will create and disseminate such materials to their Essure implanting physicians.

The FDA specifically advised Bayer that, “these restrictions on sale and distribution are necessary to provide reasonable assurance of the safety and effectiveness of the device. Your device is therefore a restricted device subject to the requirements in sections 502(q) and (r) of the act, in addition to the many other FDA requirements governing manufacture, distribution and marketing of devices.” Bayer clearly has not complied with the FDA mandates, yet they are allowed to proceed with “business as usual.” What level of assurance can you provide that hundreds, if not thousands of women will not be implanted without getting adequate warnings? It is believed that Bayer failed to send out any Dear Doctor letters to the implanting physicians advising them of the FDA’s mandatory requirements and it is obvious that Bayer is not rectifying this situation.

What plan does the FDA have to ensure the safety of these women? This is a particularly egregious situation as it appears our fears are being confirmed in that physicians are aggressively implanting women until all remaining Essure stock is utilized. Many physicians are aggressively promoting Essure to the point of taking to twitter: “If your OB-GYN smart like me, you will purchase extra Essure sterilization devices by 12/31/2018. Bayer will provide support for doing this easy sterilization in office procedure until 12/31/2019! Or, “ESSURE in office, patient is awake, doesn’t hurt, takes 5 minutes. Female sterilization is much safer in properly selected patients than in hospital, go to sleep Laparoscopic tubal!. Most OB/GYNs I know will do them until 12/31/2019.” (See attached examples) We simply cannot allow this to continue for another two years until kits are expired. Therefore, Essure should no longer allowed to be offered and Bayer should be required to repurchase all outstanding inventory so that doctors will not continue to blatantly implant the device, without compliance with your mandates.

We are including a few statements from women implanted after the April 9, 2018 mandate below. We have received multiple complaints. We have advised them to file adverse event reports as well as report their physicians to their state medical boards for not giving them the mandated checklist. We would greatly appreciate a response regarding this urgent situation.

Thank you,

Essure Problems Administration

(Names have been edited here for privacy reasons)

My name is XXXXXX.

I was Implanted with Essure on May 7th 2018 by Doctor XXXX Ob/Gyn in Irving Texas. Prior to my procedure I was not given a black box warning or a patient check list by my doctor. My doctor also knew that my pregnancy Medicaid would run out before I was due to come in and have the HSG confirmation test.

Although only being implanted for a short time I have had sharp stabbing pains in my abdomen that almost feel as I’m being electrocuted. Hair loss, fatigue, loss of appetite, very emotional, constant cramping and I have been bleeding since the procedure. Essure can NOT continue!

My name is XXXXXX. I was implanted with essure on April 25th 2018. Not given the blackbox warning, a checklist or any kind of information regarding essure. I also had signed papers to have a tubal and got the essure. Since then I have requested my records and got the run around as to why they have not been made available to me yet and it has since been 2 weeks.

My name is XXXXXX I was implanted with the essure on August 10th 2018 by Dr Ayman Dahman. I wasn't given the black box warning or physician check list.