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. On February 29, 2016, authorities at the FDA ordered Bayer to conduct a 7-year study on Essure complications, in hopes that prolonged scrutiny will shed new light on the birth control implant’s potential issues.
Essure Procedure: Side Effects & Long-Term Risks
We already know a good deal about the short- and medium-term side effects linked to Essure, a permanent contraceptive device. 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.
Today, the Food & Drug Administration has received over 18,000 reports, submitted both by patients and medical providers, that link Essure to severe complications. Alongside these commonly-reported side effects, consumer advocacy group Essure Problems has compiled an exhaustive list of the complications attributed to Essure. In all, the organization notes 145 separate side effects, from autoimmune disorders to degenerative bone disease.
What Complications Do Side Effect Reports Describe?
In May 2016, our experienced product liability attorneys performed an exhaustive analysis of nearly 10,000 Essure-related medical device reports submitted to the Food & Drug Administration. The federal records, stretching back to November 2002, had been made public by the FDA, in a rare move following widespread public outcry over Essure’s reported side effects. Our lawyers dove in, searching through the 12,908-page document and classifying each adverse event report by the complications mentioned. In the end, our analysis 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)
- Abnormal weight gain (mentioned a total of 1,619 times)
- Cognitive effects collectively referred to as “brain fog” (marked by symptoms of mental “cloudiness” and impairments of short-term memory, brain fog isn’t a medical condition in and of itself, according to Healthline. It’s a symptom of other medical conditions)
- Cysts (referred to 1,299 times. “Ovarian cysts” are mentioned 392 times)
- Depression (1,293 reports mention some variant on depression, while a further 853 note anxiety. Thoughts of suicide are referenced 133 times)
- Nausea and vomiting (noted a total of 1,248 times)
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.
Lawmakers Say Bayer Is “Dragging Its Feet”
Bayer was ordered to conduct this long-term study by federal officials, but some members of Congress believe the company isn’t taking its obligations seriously. In a letter to Dr. Scott Gottlieb, acting Commissioner of the FDA, three lawmakers accused the FDA of allowing Bayer “to drag its feet,” the Regulatory Affairs Professionals Society reports. Bayer’s proposal for the study, approved by authorities at the agency, called for 2,800 women to be enrolled – 78 new patients each month.
However, “a year and a half after the study was initiated,” Democratic State Representatives note in the letter, “it is unclear whether Bayer has acted with urgency to enroll patients.” While 60 testing sites have now been approved, only 1 patient has been enrolled so far, Representatives Rosa DeLauro (D-CT), Jan Schakowsky (D-IL) and Louise Slaughter (D-NY) write.
That claim, leveled by members of the US Congress, directly contradicts Bayer’s public statements that about 100 patients have been enrolled in the study.
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.
Out of the 18,000 side effect reports now logged with the Food & Drug Administration, over half ended in invasive surgical procedures “because of severe problems such as pregnancy, auto-immune disease, and device migration leading to organ and tissue perforation,” members of Congress have found.
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.
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.