In advance of the release of Netflix’s documentary ‘The Bleeding Edge,’ Bayer finally pulled the plug on Essure in the United States. By the end of 2018, Essure will be fully off the market. Hear that? It’s the sound of thousands and thousands of women rejoicing at this victory! Intended to be a hormone-free, surgery-free, easy method of female sterilization, the Essure debacle is as a reminder that some things are too good to be true.
Its concept was simple: the small metallic helical device would be inserted through the vagina and into the fallopian tubes via a catheter, where it would trigger an inflammatory response consequently creating a scar tissue barrier that would block sperm from travelling upstream to meet the awaiting ovum. Personally nothing seems simple about inserting something metallic into my body and occluding my tubes with scars. Their website, however, proclaimed 99.3% efficacy once the fibrotic barrier was created and, considering the device is flexible, it would move with your body so it shouldn’t be physically inhibitory. One could enjoy regular intercourse with their partner worry-free: An Egg is an Egg, and a Sperm is a Sperm, and never the twain shall meet.
Unfortunately that wasn’t always the case. Since its approval in 2002, there have been many women who did become pregnant after implantation and suffered because of complications, ranging from ectopic pregnancies to the device puncturing the amniotic sac resulting in premature labor or loss of the baby. According to ‘The Bleeding Edge’ there have been more than 800 failed pregnancies reported. Over 21,000 women complained of chronic, debilitating abdominal pain, others suffered chronic headaches; some in effect lost their sex life with their partner entirely because the pain was so excruciating.¹
The nickel-alloy and polyester coil touted as a less-invasive alternative to tubal ligation was pulled from all other markets last Fall after reports of debilitating pain, excessive bleeding, nickel-allergies, and many cases of required hysterectomies. However, it remained available in the United States because the Food & Drug Administration (FDA) declared the benefits outweighed the risks.
So what changed their mind? It seems the impeding outcry from the Netflix documentary was sufficient to spur them to action. The announcement to halt sales came just one week before the July 27th release date of ‘The Bleeding Edge.’ The documentary examines complications caused by medical devices, the corruption between the manufacturers and doctors, the fallibility of the FDA’s Pre-Market Approval (PMA) process in respect to ‘innovative’ technologies, and brings some much needed attention to the disastrous effects these devices have had on the lives of their users.
Aside from the tragic consequence suffered, the documentary reveals some pretty astonishing information about the product’s history. Essure’s pre-market studies observed a small number of women for only 12-18 months, which is an incredibly short period of time considering it is supposed to remain in the body permanently once implanted. There was also no study information on what the risks would be if someone were to become pregnant. Even with many serious questions still unanswered, the FDA cleared it and let it go to market.
Also ‘The Bleeding Edge’ shows there was clear lack of communication between the manufacturer and the medical personnel in charge of their use. Evidently not all doctors were properly instructed on implantation and removal. Several scans are shown where a woman has several coils in her uterus because of failed prior attempts to properly place them in the fallopian tubes. In cases where the device had to be removed, there was no set protocol for doing so. Sometimes the doctors had to improvise, occasionally pulling on them, consequently causing them to stretch and break, the shards of which subsequently caused autoimmune responses in those patients. In many cases, a full hysterectomy was required in order to completely remove them from the body.
It was intended to be a permanent sterilization solution – sadly so many women were unaware of just how permanently their lives would be altered.
The market withdrawal of Essure cannot undo the damage these countless women have endured, but let us all cheer that never again will it claim another victim.
Check out ‘The Bleeding Edge’ on Netflix to hear the full account of their stories.