AAGL Members

Shawn Tassone, MD PhD

12200 Renfert Way

Austin, TX

11/15/15

Dear Colleagues,

I am writing this letter as I am unfortunately unable to attend the meeting and discuss this in person, but I wanted to have my voice heard.

I am a board certified OBGYN and have been so since 2000. I was an instructor for Conceptus and helped physicians bring the Essure product into their offices from 2008-2013. In the course of those years, I myself placed hundreds of Essure coils and to my knowledge had at least three pregnancies.

Because of my own research into the product I stopped placing the coils in 2013 after my last patient became pregnant and had to have an abortion. Obviously, one of the issues with this mode of sterilization is confirmation with HSG, especially in those patients with Medicaid because many of them are dropped after the procedure is performed and they never have the testing done.

Beginning about 16 months ago I began removing the coils in my practice and since that time have had at least thirty opportunities to try and remove these coils via hysterectomy or bilateral salpingectomy. I have seen other physicians attempting bilateral salpingectomy and have witnessed multiple Essure fractures or pieces of the device left behind. What I find is that many physicians are simply performing a salpingostomy and then pulling the coil to remove it. The Essure is a fragile device and was not meant to be pulled upon because it can break. I have also seen physicians pulling on the coils hysteroscopically causing internal bleeding and tubal damage. Lastly I have seen reproductive endocrinologists removing the tube and coil and then performing reanastomosis with a small portion of tube and subsequent severe pelvic adhesive disease.

I am not an academic although I am very well trained and pride myself on my background. I am seeing women from the ages of 26 to 51 and what I have discovered is that there is no good way to remove these coils short of a hysterectomy. I say this for a few reasons. Primarily, the Essure coils are made to cause an inflammatory response. There is no “off-switch” to this inflammation and one would understand that this inflammatory response would basically destroy the tube and continue to be inflamed. If you simply remove the device by pulling (thus leaving inflammatory PET fibers like polyester) or by excising the uterus in a partial conruectomy there is continued inflammation and potential pelvic adhesive disease of the pelvis.

I have done laparoscopic conrnuectomies on young women who simply do not want a hysterectomy, and sadly I feel they will eventually have the hysterectomy because of continued issues with pain and bleeding. I currently have over 60 women on a waiting list that want their coils removed because they do not want a hysterectomy and I am not sure, in good conscience, that I can recommend this procedure unless they are truly expecting to have IVF or some other infertility procedure because of the desire for future childbearing.

I would like the members of AAGL today to consider looking at Essure removal as an important topic for those of us in the trenches seeing these patients on a daily basis. I would like to have a consensus on how to remove these coils whther it be with hysterectomy, which I know works, or some other laparoscopic procedure which cannot guarantee removal of the PET fibers in this product.

I have no financial affiliation with any group and I have no personal conflict with Conceptus or Bayer. I believe there was good intention to have hysteroscopic sterilization but shouldn’t we have a standardized way of removing the device that benefits the best outcomes for the patients and not multiple physicians trying different things to the best of their abilities? If a patient says her IUD hurts, we take it out, because we can. I would like the same for women with Essure.

I hope you will look into the matter and I thank you for your valuable time. Please feel free to contact me.

Shawn Tassone, MD PhD

Austin TX

512-451-8211