Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Bayer’s New Headache

By Dr. Christopher Joseph Devine
6 Comments
Dr. Christopher Joseph Devine, President, Devine Guidance International

Problems have persisted with the Essure System. What’s FDA’s next move?

As many of the readers already know, the Bayer name is synonymous with its hallmark brand, “Aspirin.”  I am sure Dr. D’s readers are wondering by now and wanting to ask the doctor the million-dollar question: “What in the heck does Aspirin have to do with medical devices?” In the case of Bayer, the executive management team is probably throwing back some aspirin right now with an H2O chaser because of a medical device they acquired a couple of years ago as a result of an acquisition, the Essure System. The Essure System is a permanent form of birth control that does not require a surgical incision. According to FDA, “over the past several years, the FDA has been examining the growing number of reports of harm with Essure. The adverse events reported associated with the use of the Essure System include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure System failure, and, in some cases, incomplete patient follow-up have resulted in unintended pregnancies.” Hopefully, the Bayer product team and Chief Jailable Officer (CJO) tasked with managing the Essure platform is not growing to obstreperous (look-it-up) as the Essure System continues to rack up Medical Device Reports (MDRs). Enjoy!

Brief History of the Essure System

The Essure System’s Premarket Approval Application (PMA) was initially approved by FDA on November 4, 2002 (P020014). The original PMA was submitted by Conceptus, and on June 5, 2013, Conceptus was acquired by Bayer. According to FDA, there were two conditions associated with the initial PMA approval: (a) the gathering of five-year follow up information on the participants in the two premarket clinical trial patient cohorts (Phase 2 Trial and Pivotal Trial), and (b) the ongoing evaluation of bilateral placement rates for newly trained physicians. Since the initial approval of the PMA by FDA, there have been multiple supplements with some of the significant issues being addressed such as:

  • A warning (contraindication) for nickel sensitivity
  • Information presented that was associated with the five-year follow-up of clinical data (including pregnancies, which are always bad when talking about contraceptive devices)
  • Updated patient risks such as post-procedure patient pain and device migration

FDA’s Concern

Being inquisitive by nature, Dr. D decided to search the FDA’s MAUDE database for MDRs associated with the Essure System and was surprised to find 500 MDRs filed for just 2015. Additionally, the doctor was quick to notice that the FDA has been investigating the growing number of adverse events associated with this device such as: (a) persistent pain, (b) perforation of the uterus and/or fallopian tubes, (c) intra-abdominal or pelvic device migration, (d) abnormal or irregular bleeding, and (e) allergy or hypersensitivity reactions. Furthermore, FDA’s growing concerns led to the agency’s holding of a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015. The salient purpose of this meeting was to compile expert scientific and clinical opinions as well as patients’ experiences regarding the benefits and risks of the Essure System.

According to a blog article posted by the law firm of D’Amico, Griffin & Pettinicchi, LLC, there have “been thousands of complaints about severe health problems,” including at least four patient deaths. The blog also states that Congress has introduced a bill to force withdraw of the Essure System from commercialization. Finally, FDA has stated that their investigation and next steps will be communicated to the public by the end of this month. That being said, Dr. D’s question is, “Why wait?”

Takeaways

For this week’s guidance there really is no takeaway. Dr. D stumbled across a serious device concern and wanted to raise awareness of how the FDA sometimes approaches serious device issues. It is the doctor’s humble opinion, premised on what has already been placed into print, that just maybe the agency is a little too slow in forcing a potentially high-risk product from the device market place.  The doctor will be anxiously awaiting the agency’s decision later this month and promises to keep the readers informed. In closing, thank you again for joining Dr. D, and I hope you find value in the guidance provided. Until the next installment of DG, cheers from Dr. D., and best wishes for continued professional success.

References

  1. D’Amico, Griffin, & Pettinicchi. (2016, February). Four deaths, severe injuries, linked to Essure contraceptive device. Accessed February 4, 2016. Retrieved from http://www.dgplaw.com/blog/2016/02/essure-medical-device-health-problems.html
  2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system   regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
  3. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
  4. FDA. (February 2016). Regulatory history.Accessed February 2, 2016.  Retrieved from http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/essurepermanentbirthcontrol/ucm452270.htm
  5. FDA. (February 2016). Update on the status of FDA’s evaluation of the Essure System. Accessed February 2, 2016.  Retrieved from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/default.htm

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International

Comments

  1. Carl Jacobs

    NICKEL sensivity?…Nickel has been a known metallic problem child for years in the orthopedic implant industry and has been scrupulously avoid due to known, demonstrated. Tissue sensitivity in standardized tests. Conceptus should never have used it and Bayer should have realized they were going to have trouble if their initial due diligence had been done properly with sufficient biomaterial expertise on the buy-out team….. The PMA approval team at FDA should have demanded ‘proof” that the device containing Nickel did not pose a threat…..

  2. Dr. D

    Carl, thank you for reading DG. Great comment in regards to nickel. My biggest concern is that FDA has not acted quicker (e.g., similar to the agency’s delay in addressing the reprocessing issues associated with endoscopes). Be Well, Dr. D

  3. Dr. med. Karl H. Kurz

    Timely I warned the staff of Bayer to stay away from the aquisition of CONCEPTUS because Essure does not regard the physiologie of the non- pregnant Uterus, the strongest muscle of the human body. The utero tubal junctions are nerve triggered and irritations there can cause uterine contractions up to 350 mm Hg likewise during delivery. (Normal maximum during menstruation up to 150 mm Hg.) My mail was accepted but there was no answer of the management. Nowaday decisions seem mostly be made by the financial managements.

  4. Dr. D

    Dr. Kurz, thank you for your comments. No doubt the fiscal element associated with the device industry plays a significant role when deciding to enter medical devices that may be less than safe and effective into commerce. Thank you for reading Devine Guidance. Be Well, Dr. D

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