The Essure permanent birth control system was designed to be an alternative to the surgical form of permanent birth control like tubal ligation. Essure was said to be 99.83% efficiency rate and however, many women have claimed that the device has caused life altering injuries in the women who have them implanted and want this device removed from market and banned.
This is a non hormonal-based system for women sold by Bayer that can be got by prescription only. Once this device is inserted into the body it was intended to be irreversible just like other traditional methods such as tying tubes. The system consists of two stainless steel flexible coils and fibers made up of Nickel titanium and polyethylene that is inserted into the fallopian tubes. Over 750,000 women choose this as their preferred form of birth control.
Essure Birth Control was initially manufactured by Conceptus Inc. and got it approved by the FDA in 2002. In the year 2013 Conceptus was bought over by Bayer for $1.1 million and started to market Essure as the only FDA approved permanent form of birth control.
While Bayer maintained the claim that their device was safe and effective thousands of women came forward with complaints that this device caused injuries such as perforation of the fallopian tubes, severe pain and neurological damage. In several cases the women even lost their lives.
After records showed that there were thousands of adverse effects of this device the FDA held a meeting in September 2015 to examine the safety of this device.
Working of Essure Birth Control
Once the device is inserted into the fallopian tubes scar tissue starts to form within three months and this scar tissue blocks the tubes. During the time of formation of the scar tissue the woman is still required to use other methods of contraception to prevent any chance of pregnancy and can stop once the follow-up checkups with the doctor proves that the tubes are fully blocked. The ovaries still continue to release eggs but the sperm is not able to reach the egg and hence the egg remains unfertilized and in times gets decomposed and reabsorbed by the body.
The main reason why this was a preferred choice for many women was because it is a fast procedure that takes less than 10 minutes and does not require anesthesia as opposed to tying of tubes. A thin disposable metal catheter containing the compressed Essure coil is used to insert the device through the vagina. When the doctor positions and inserts the tube at the entrance of each of the fallopian tubes these coils expand to 1.5 inches and anchor to the walls of the tubes. Most women are able to resume their normal life right after the procedure however with some complaints of cramping and mild discomfort.
Reversal of this process
This is a complex procedure to reverse as the coils were not designed to be removed and the scar tissue cements the coils in place. However some surgeons have the skill to be able to cut out the coils by making a small cut over the pubic hairline and then make small incisions in the fallopian tubes and carefully cut out each of the coils along with the surrounding scar tissue before rejoining the fallopian tubes. However, these tubes may rupture in the later stages of pregnancy.
If the removal of Essure goes wrong it may cause damage to the uterus and require the doctor to do a complete hysterectomy which can affect the quality of life of the woman.
Side Effects of Essure
The side effects that are seen in the first year of implantation of Essure include
- Abdominal cramps
- Back pain
- Leg and arm pain
- Severe cramp
- Abdominal pain and bleeding
- Vaginal discharge and infections
- Painful intercourse
Essure birth control also showed more severe side effects that included
- Heavy periods
- Weight fluctuations
- Device incompatibility
- Device migration
- Breakage of the device
- Malposition of device
- Device operating unexpectedly
Essure Linked Deaths
Along with the above mentioned adverse effects the FDA found 5 confirmed cases of fetal deaths caused due to this birth control. There were even four reports of women death that was caused due to infection, uterine perforation, air embolism and suicide. In 2016, an analyst found that there were around 303 cases of fetal death related to the Essure birth control system and more that 10,500 adverse effects of it.
FDAs action towards Essure
The FDA did not ban the device as most women expected but they sent out a list of advice relating to the use of Essure birth control.
- The patient should be carefully selected and should sign a patient checklist that acknowledges that they understand the complications related to this birth control system.
- Women who are hypersensitive to nickel should not opt for this procedure.
- Doctors should inform the patients about the risks involved with this procedure.
- Those women who suffer from various diseases such as autoimmune disorders, chronic pelvic pain or have undergone previous uterine surgery should not use Essure.
- The physicians who deal with Essure should be better trained.
The FDA also encouraged the manufacturer to add a black box warning about the adverse events related to Essure.
Although Bayer claimed that the device was 98.83% accurate; research conducted by the FDA showed that 10% of the women who had this implanted were able to get pregnant. Other studies showed that 15 women had a hysterectomy after using the device; 38% of the women had unusually heavy periods; 5% had recurrent pelvic pain; and 4% complained about painful periods. Many women also claimed that the reports made by Conceptus was falsified and in April 2015 the FDA investigated these allegations and found that six of the cases submitted by Conceptus were tampered with.
Because of the major attention that this case got on social media several law makers have taken notice of this and have sponsored bills that intend to make medical devices safer.