After years and years of horrifying side effect reports, Congressional outrage and legal action, the US Food & Drug Administration has finally decided to investigate the long-term side effects of Essure in detail.
Essure Procedure: Side Effects & Long-Term Risks
We already know a good deal about the side effects linked to Essure, a permanent birth control implant. Chronic pelvic pain, abdominal bloating, migraine-type headaches and debilitating fatigue appear to be most common. These apparent risks have been reported by numerous women, beginning shortly after the device’s initial approval in 2002. Routine clinical trials performed by Essure’s original developer, Conceptus Inc., came to similar conclusions.
One study, which followed participants for up to 5 years, found that one in eight women experienced abnormally painful menstruation, a common complaint among Essure recipients.
In 3% of the women studied, an Essure implant perforated the fallopian tube. Surgeons were unable to remove the dislodged device from one participant’s abdominal cavity. Back pain, abdominal pain and painful sexual intercourse were also reported. A second study, in which only 366 of the original 518 subjects could be followed for five years, found that nearly 38% of participants experienced abnormally heavy menstrual periods on a recurring basis. Around 5% suffered from recurrent pelvic pain, while almost 7% experienced painful menstruation on a regular basis.
5 years may seem like a long time, sufficient perhaps to identify long-term side effects of the Essure procedure, but the device itself is intended to be permanent. “Long-term” takes on new meaning when an implant is meant to remain inside patients’ forever. The true long-term consequences of Essure, those created by decades of use, are still unknown.
FDA Orders New Long-Term Safety Data On Essure
A new study, conducted by the birth control device’s manufacturer Bayer, hopes to track the health outcomes of Essure over a 7-year-period. The project will follow 2,800 women, half of whom are slated to receive Essure implants. The remaining 1,400 will undergo tubal ligation procedures.
While this is critically necessary research, it is not a project Bayer has undertaken voluntarily. Instead, the company has been ordered to examine Essure’s long-term adverse consequences by FDA health officials. The study’s results, according to Virginia ABC News affiliate ABC8, won’t be ready until 2023, although two interim reports are due to be published in 2017.
Ten-Fold Increased Risk Of Reoperation
Another serious, and shocking, side effect of Essure is actually a surgical operation. Many women have undergone hysterectomy procedures to end the severe pain and other long-term side effects associated with Essure.
Compared to women who underwent minimally-invasive surgery for sterilization, women who receive Essure implants are 10 times more likely to need a second operation, according to researchers in the British Medical Journal.
Notably, this reoperation risk is not a long-term side effect of the Essure procedure, at least under normal interpretations of “long-term.” The study only analyzed reoperations that became necessary within 1 year of initial implantation. Even so, women with Essure were over 1,000% more likely to require a second fallopian tube procedure than those who received laparoscopic sterilization.
Essure Problems Can Begin Early
For many women, Essure problems don’t arise in the long-term. Instead, the issues begin right away, even during the device’s implantation procedure. In one clinical trial, nearly 9% of implantation attempts were unsuccessful. In another study, the initial failure rate reached a shocking 25%.
With repeated attempts, researchers were able to implant around 88% of their study’s 269 applicants successfully. In nine of these patients, an Essure coil perforated the fallopian tube or lodged itself in some other body part.
Our own analysis of more than 9,800 side effect reports found that Essure’s most common side effects appear to be:
- Pain (nearly every report mentions “pain” at least once. Throughout 9,884 total reports, “pain” is referenced 24,015 times, or 2.4 times per report)
- Bloating (usually in the abdomen or stomach)
- Headaches (often described as searing “migraine” headaches)
- Fatigue (frequently described as “extreme” and “chronic”)
- Hives and rashes (many women believe that skin problems are caused by the nickel out of which Essure is partially made)
To date, Essure has been linked to at least four adult deaths, 15 fetal deaths and 631 pregnancies, the Regulatory Affairs Professionals Society reports. The FDA has been flooded with reports of horrific side effects, submitted by physicians and patients alike.