Essure and the new Black Box Warning

Say What

Essure, a minimally invasive, permanent, contraceptive device was recently placed in a box.  The FDA has tagged Essure with a black box warning.

With all the social media and news coverage of late, I would be extremely surprised if you haven’t heard anything about this. Even THE Erin Brockovich has weighed in:

Seems to me that all we hear about are THE BAD outcomes associated with this device. Personally speaking, the women that I serve and have placed this device in have all done well. That’s not to say that I don’t believe any of the claims being made against Bayer; just that I haven’t seen the sorts of injuries or complications being named in my patient population. Neither have a lot of my colleagues.

As I was doing a laparoscopic bilateral tubal ligation the other day, I thought to myself, this would have been a good Essure case. People fail to realize that procedures such as laparoscopy, general anesthesia, etc., have their own set of risks, including, but not limited to: not waking up from general anesthesia(imagine that!), injury to neighboring organs(bowel or bladder anyone….or how about those major vessels if indeed a veress needle is used for insufflation of the abdomen), risk of further surgery such as a laparotomy if issues with bleeding or scar tissue ensue……..

As I continue to stand in observance of all that is transpiring concerning Essure, its safety, etc., I keep wondering if informed consent was ever truly obtained in these cases. Did the physician performing the procedure warn the patient of things such as but not limited to: risk of tubal/uterine perforation? Device migration? Injury to neighboring organs? Device failure?

Were these patients truly good candidates for the Essure device? Were all precautionary measures taken by the physician performing the procedure; i.e., not forcing the device against resistance?

So many variables to consider.

Let me be very clear. By no means do I sit in the seat of judgment or am I accusing anyone of wrong doing…..just that I do find it a bit odd that neither myself or any of my colleagues are seeing said issues in our patient population.

Essure is NOT for everyone. Just like oral contraceptive pills are NOT for everyone. Having said such, I would really hate to see the only minimally invasive, permanent, contraceptive option on the market removed unnecessarily.

Women’s health takes a HIT on so many different levels. First the morcellator, now this?

If I recall, I’ve seen the same sort of hysteria surrounding products such as Mirena. At some God forbidden hour in the morning we’ve all seen THOSE legal commercials soliciting folks that have had “bad outcomes” from Mirena use. I’ve been inserting Mirenas for years and have only seen one that migrated outside the uterus. By and far, most of the women that I know that use the Mirena IUD do very well.

We are all entitled to our own opinions. We all have our own experiences.

To all those adversely affected by the Essure, I’m truly sorry for what you have experienced. For those considering it as a permanent contraceptive option, make sure that you review ALL of your options and that INFORMED consent is truly obtained. Contrary to popular belief, there are lots of women and physicians who have had and continue to have GOOD outcomes with the Essure device(click here to listen to my podcast on Essure).

Hoping this blog post has added value to your day!

Until Next Time,

Look Better. Feel Better. Be Better.

Dr. Angela

About Dr. Angela

Mother, Midwesterner, and award-winning OB/GYN, Dr. Angela is equal parts best girlfriend and bold professional, supporting women’s health with innovative approaches to care and heavy doses of humor. Dr. Angela has done more than launch a successful practice, she has defined herself as a voice for a new generation of womanhood, established her ASK DR. ANGELA brand committed to authenticity, and built a community rooted in trust, candor, and compassion.

What do you think?