What’s Next after the Essure Recall?
Anyone who has watched the new Netflix documentary “The Bleeding Edge” will understand why some women and activists had campaigned for the withdrawal of the permanent contraceptive device Essure from the market.
The film from Oscar-nominated documentary filmmakers Kirby Dick and Amy Ziering was released on Netflix on the 27th of July 2018. The film investigated the $400 bn medical device industry, and it targeted five medical devices, including the permanent birth control device Essure.
Watch the trailer here:
In the documentary, viewers discover what Netflix described as “examining lax regulations, corporate cover-ups, and profit-driven incentives that put patients at risk daily”. We learn that medical devices are often fast-tracked through the United States Food and Drug Administration without rigorous testing. This puts patients at risk to develop serious adverse events.
Until now, some persons how the company was able to get a Premarket Approval for the contraceptive device. If you’re not familiar with the regulatory process, a Premarket Approval is the most stringent type of device marketing application required by Food and Drug Administration. Therefore, it comes as a shock to many that such laxity could exist in the medical device industry.
While the pharmaceutical giant Bayer claims that the documentary painted an inaccurate picture of Essure, the producers of the filmmakers believed it was important for the public, healthcare practitioners, and policymakers to know about the ongoing problems in the medical device industry.
An Overview of the Essure SystemThe Essure birth control device is a type of permanent birth control for women. The device consists of a small metal and fiber coils.
During the procedure, the doctor uses a hysteroscope to place the device in the woman’s fallopian by inserting it via the vagina, cervix, and uterus.
The device takes approximately three to four months to become efficient at preventing pregnancy. During this time, the women who’ve undergone the procedure are advised to use another birth control method.
Benefits of the Essure System
- This birth control method was reported to be very effective. The risk of getting pregnant after proper coil placement was minimal (approximately 0.1%).
- The procedure was pretty straightforward and could be performed with little or no anesthesia.
- Women who underwent the procedure could resume their daily activities the day the procedure was performed.
- The procedure did not require any incisions.
However, the manufacturer warned that certain risks were associated with the procedure and the device was not right for every woman.
Risks Associated with the Essure System
The following problems have been reported by women who had Essure:
- Lower abdominal or pelvic pain
- Allergic reaction to the metal coils
- Heavy bleeding
- Uterine or fallopian tube perforation
- Migration of the coils
- Unintended pregnancy due to poor placement of the coils
- Infection due to a poor aseptic technique
The Future of Essure
Days before the documentary was released on Netflix, Bayer announced it would withdraw Essure from the United States markets. Bayer executives said the plunging sales of the birth control device prompted them to stop selling them.
However, they affirmed the device was safe and effective, with up to 97% of women reporting being satisfied to very satisfied after having the Essure system implanted.
The group Essure Problems reports the contrary. They have a Facebook group of 30,000+ members who have had the Essure procedure and are suffering or have suffered from side effects that may be attributed to the birth control device. They reported that about 34,000 women worldwide have complained about adverse effects after having their Essure implants.
Additionally, as of January 2018, more than 16,000 women in the United States alone had filed Essure lawsuits. It is possible that after the release of the Netflix documentary “The Bleeding Edge”, more women have found that their birth control device was probably associated with previous symptoms or medical issues. It is also likely that the number of Essure lawsuits against the pharmaceutical giant could escalate.
Although Bayer declared it would end sales of the contraceptive implant in the United States after the 31 of December 2018, new lawsuits are expected given that the device is meant to be permanent.
It is not sure whether the pharmaceutical giant plans to offer any form of settlement to plaintiffs who reported severe adverse events with Essure. Furthermore, it seems the continue is prepared to continue fighting old and new lawsuits.
Meanwhile, we need to ask ourselves how safe we are if the medical device industry appears to be less regulated than pharmaceuticals.
Have you watched “The Bleeding Edge”? What is your take on those shocking revelations? Can we rely on the medical device company and be confident that what they do is in the best interest of the patient?