Approved by the Food & Drug Administration (FDA) in 2002, the Essure System for Permanent Birth Control® is labeled as a 10-minute, non-surgical, procedure that can be done right there in the comfort of your doctor’s office. The device’s developer, Conceptus Inc. (acquired by Bayer in 2013), advertises Essure as safe alternative to tubal ligation, a surgical procedure which is commonly known as having one’s “tubes tied.” For women who wanted to avoid unplanned pregnancy, Essure appeared to be a low-risk option with a quick recovery. Since it’s been on the market, however, thousands of women have come forward with horrific stories of adverse effects.
What The FDA Is Saying about Essure’s Safety
In September, the FDA convened a committee to discuss the risks and benefits of the Essure System. The large auditorium in Silver Spring, MD was packed full women who condemned Essure’s manufacturer for putting a device on the market without first collecting sufficient data on allergies and other risks. Some women who participated in the clinical trials even claimed that their answers were altered by clinical investigators to skew the data, an allegation Bayer has denied.
Some experts have called for more research, saying the device had been “poorly tracked” since its approval. But the growing number of victims insist that the device should be recalled. In November, U.S. Representative Mike Fitzpatrick (R-PA) introduced a bill to take Essure off the market to prevent more women from suffering serious, life-changing injuries. In a statement, Fitzpatrick said:
“Bayer is a trusted name in the industry. However, right now, one of their products, the Essure device, is harming women and needs to be removed from the market . . . I believe it is imperative to the continued success of their brand and the other work they do to immediately end production of a product that poses such a danger to patient safety.”
As more women come forward, the evidence is beginning to show that fast-tracking Essure to market was an irresponsible, costly mistake.
What’s Wrong with Essure
Essure was approved as a Class III medical device, which are, “those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.”
Essure is a soft, flexible coil which is inserted into the fallopian tubes of a woman. The coils trigger an inflammatory response, causing scar tissue to form around the coil, blocking the fallopian tubes which keeps sperm from reaching the eggs. Promising an alternative to surgery with a quick recovery, the device was approved as a safe form of permanent contraception, but for thousands of women, Essure has been a medical nightmare.
In a study released by the British Medical Journal (BMJ), researchers found that women who opted to use Essure were 10 times more likely to need surgical reoperation than women who underwent tubal ligation. In short, advertising Essure as a surgery-free option is turning out to be a false promise to many women who find themselves in the operating room after having the device implanted.
The FDA has updated the status of their evaluation of Essure as more and more women report being harmed by the medical device. They write:
“The adverse events reported associated with the use of the Essure System include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure System failure, and, in some cases, incomplete patient follow-up have resulted in unintended pregnancies.”
Along with these painful symptoms and the possible need for surgery, women who have the Essure procedure are at a higher risk for ectopic pregnancy, which can be fatal. Instead of being a successful Class III device, Essure has left many women with serious concerns about their health and safety.
Diligence of Manufacturer Called into Question
In a recent article, the New England Journal of Medicine (NEJM) raised concerns that Essure’s manufacturers could have done more to evaluate the safety of the device. There were only 2 non-randomized, non-blinded prospective studies that lacked a comparator group.
Furthermore, only 25% of the women who underwent an attempted Essure procedure, “were followed for effectiveness at 2 years, which further limited the evaluation of adverse events and device safety.” For a device that stays inside a woman for life, only a few women in the study were followed for a year, a limitation they say, “precludes conclusions about longer-term risks.”
In their conclusion, the NEJM argues that:
“Given the limitations of the relevant studies, it's not surprising that so many years passed before safety issues with Essure were recognized. . . Though Essure offers possible advantages to women seeking sterilization, the evidence suggests that it is neither as effective nor as safe as the premarketing-approval evaluation indicated.”
As the awful stories of women who underwent an Essure procedure continue to grow in number, it’s hard not to wonder why the device didn’t undergo more stringent testing before it was used on thousands of women. Next month, the FDA is scheduled to announce their findings based on the September hearing. For the thousands of women who suffered from Essure, there is hope that lawmakers will act on the evidence, get help to those who need it, and prevent more women from paying for false promise with their health.