NovaSure Endometrial Ablation

In November 2015, my mom got a procedure called NovaSure endometrial ablation. This procedure is done on women who experience irregular, heavy menstrual flows that last days past the typically menstrual phase of the uterine cycle. The main side effect of this is heavy pain and cramping. In NovaSure, a device is placed into the uterus of the woman that "destroys the inner lining of the uterus" (the endometrium) through radio-frequency energy (1,2). After the procedure, my mom was told that she would not have her period anymore, and if she did it would not be heavy and last days on end. However, just a few months after the procedure, my mom was seeing side effects her doctor never warned her about.

Unbearable pain, heavy flow that is heavier than ever before, and strange discharge were some of the symptoms my mom complained to her gynecologist about just a few months after the procedure. How could this have happened when her gynecologist said nothing about a period returning with no such side effects and the NovaSure website says nothing about these side effects (2)? The gynecologist had no explanation as to why, but just suggested my mom getting a partial hysterectomy, a procedure in which the whole uterus is removed. From a physiological standpoint, we know that the endometrium grows back every month during the proliferation phase of the uterine cycle from high levels of progesterone. The gynecologist told my mom this would not happen due to scar tissue on the bare end of where the endometrium used to be, but how has she still gotten her period so irregularly, sometimes missing months at a time? This is a hard question to answer since the uterus is so complex.

My mom had told me that there were several civil/class action suits on NovaSure and the FDA from women who experienced similar side effects after the procedure just like she had. I looked into this and found a petition website that is targeting the FDA, the administration that approved the NovaSure procedure (3). In the comments section, I read hundreds of testimonies by women who have experienced similar symptoms my mom had and even worse (like infection and painful sex) just months after the procedure. A lot of their symptoms are still ongoing after years the procedure has been done. Doesn't all of this go against the biomedical ethic of non-malfeasance?

1. Erol, M. (2014). Unnecesasry bleeding, unnecessary suffering: normalcy and necessity of menstruation in promoting NovaSure. Journal of Gender Studies, volume 25, pages 367-381. https://doi.org/10.1080/09589236.2014.987655
2. NovaSure. (2016). What is NovaSure Endometrial Ablation? Retrieved from http://www.novasure.com/patients/what-novasure-endometrial-ablation
3. White, D. (2017). NOVASURE CLASS ACTION LAWSUIT. Retrieved from https://www.thepetitionsite.com/287/347/635/novasure-class-action-lawsuit/