FDA Cracks Down on Essure Birth Control Device After Years of Complaints

The Food and Drug Administration (FDA) announced Monday that they have moved to restrict the sale and distribution of the Essure permanent female contraceptive device. Essure is an implantable sterilization device and was developed by the Bayer subsidiary Conceptus Inc. The Essure device is a microinsert made from polyethylene terephthalate (PET) fibers. They are inserted into each fallopian tube to induce an inflammatory response and the fibrosis. The fibroidal scar tissue builds over several months, during which time another contraceptive method would be required, but eventually the scar tissue should physically block the tube, thus preventing fertilization. 

Essure does not require an incision and was designed as an alternative to tube ligation, which is an invasive abdominal surgery. As described by WebMD, the most common tube ligation methods are laproscopic procedures. This means that the surgeon has to gain access to the abdomen or pelvis through two small incisions. One is usually in or below the navel and the other at the top edge of the pubic bone. The surgeon then inflates the abdominal cavity with air in order to gain clearance and inserts a laproscope. The laproscope itself has a magnifying lens and a light to help guide the ligation (cutting) instrument to the correct location. 

An NCBI study on the efficacy of the Essure system described how the small and flexible coils are inserted into the fallopian tubes through the cervix and vagina, using a coil catheter delivery system. The Essure procedure requires less anesthesia but is not without risk. FDA Commissioner Scott Gottlieb announced Monday, “We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option.” 

The FDA had no choice but to take this step after it had become clear that patients and doctors were not being adequately informed about the dangers of the device. It is not the first time the regulators expressed concerns about Essure. In 2016, the FDA ordered Bayer to provide more information about the risks of Essure and to make sure doctors were aware of the potential for complications. The 2016 order also forced Bayer to include a prominent boxed warning on Essure and a Patient Decision Checklist to make sure that the benefits and potential dangers of the product were clearly outlined. Bayer was required to complete a new post-market study into the effectiveness and adverse events related to Essure. 

Tens of thousands of adverse events have been tied to Essure. This week’s FDA announcement revealed, “Some patients implanted with Essure have experienced adverse events, including perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain and suspected allergic or hypersensitivity reactions. In addition, women have also reported experiencing headache, fatigue, weight changes, hair loss and mood changes, such as depression.”

Bayer continues to defend the product in both public arenas and in the court of law: They face over 16,000 lawsuits related to Essure. Women sounded the alarm about the dangers and failings of the product soon after it was launched. There are support groups where women share their horror stories about the device. Stories of fevers, bleeding, cramping, pain and even cases where residual metal shards were left behind after the device was removed, are frighteningly common in the Essure survivors community.

The FDA announced, “The new Essure labeling, which will now be legally required when this product is offered to a patient, restricts the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device.” The stakes are high for both patients and Bayer, “The FDA plans to enforce these requirements and will take appropriate action for a failure to comply, including applicable criminal and civil penalties.”

The failure of Essure is at this point almost assured. Sales of the product are down 70 percent and the labeling restrictions will make it impossible for any prospective patient to ignore its dangers. If you are looking into permanent or reversible contraceptives, you may be relieved to learn that you don't have to subject yourself to the risks of hormonal contraception, or learn to live with the side effects, in order to take control of your reproductive health. 

There may be no easy way to provide permanent female contraception, but there are a number of reversible nonhormonal options available. Barrier methods, which work by preventing the man's sperm from reaching the woman's egg, include the diaphragm, cervical cap, sponge and male and female condoms. None of these are foolproof, which is why many couples use them in combination with fertility awareness-based methods.

Fertility awareness involves knowing when a woman's fertile period occurs each month, and then avoiding sexual intercourse during (and just prior to) this time (or using a barrier method if you do). When used consistently and correctly, fertility awareness is highly effective at preventing pregnancy; fewer than 1 to 5 women out of 100 will become pregnant using fertility awareness in this manner. In order to track fertility, a number of methods can be used by women, including tracking basal body temperature, mucus production, saliva indicators and cervical position.
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