For the latest updates on Essure lawsuits, check out this page. This page is about Essure birth control side effects and whether a removal procedure can cure those side effects. Thankfully, the medical research shows that many women can successfully have Essure removed and treat the side effects.
There are several different ways we can discuss the side effects of Essure (or any medical implant). Below we’re going to use:
- Warnings and Adverse Reactions in the Instructions for Use
- The most common adverse events reported to the FDA
- The most common serious adverse events reported to the FDA
- The most common serious adverse events reported to the FDA but not listed in the Instructions for Use
Every medical implant comes with Instructions for Use (IFU), which is the primary way that implanting doctors learn about the potential complications. The Essure Instructions for Use include several pages of warnings about complications, including:
- An “unsatisfactory device location including perforation, uterine embedment and expulsion” can cause pain, including chronic pain. Treating the pain might require surgery, device removal, or a hysterectomy.
- Patients with “hypersensitivity” to stainless steel, platinum, titanium, or nickel can experience an allergic reaction. The Essure IFU admits “there are no known diagnostic tests that are predictive of allergic reactions to any of the components of Essure.”
- Patients have reported becoming pregnant after an Essure implant, and experiencing “pregnancy loss, premature labor, premature rupture of membranes, preterm delivery, stillbirth, genetic and developmental abnormalities.”
- About 2% of women in clinical trials had perforations around the time of implantation.
- In clinical trials, about 30% of women experienced cramping, 13% experienced pain, 11% experienced nausea or vomiting, 9% experienced dizziness, and 7% experienced bleeding.
To track side effects from medical devices, the FDA maintains the Manufacturer and User Facility Device Experience (MAUDE) database. (This is the same database FDA reviewed in 2016 when deciding on a new warning for Essure.) As of early 2017, there were over 10,000 medical device reports relating to Essure. The most common adverse events reported are:
- Abdominal pain (approximately 70% of reports)
- Menstrual irregularities (approximately 33%)
- Headache (approximately 30%)
- Fatigue (approximately 22%)
The most common serious adverse events in MAUDE are:
- Patient “incompatibility,” like a nickel allergy (22%)
- Essure migration (9%)
- Essure device breakage (5%)
Here’s an example MAUDE Adverse Event Report for Essure:
This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation (“migration of implant”) and device breakage (“fracturing of the implant”) in a female patient who received essure for sterilization. The occurrence of additional non-serious events is detailed below. On (b)(6) 2014, the patient started essure. On an unknown date, the patient experienced device dislocation (serious criteria medically significant and clinically significant/intervention required), device breakage (serious criterion medically significant), pelvic pain (“pain”), abdominal distension (“bloating”), headache (“headaches”), anxiety (“anxiety”) and depression (“depression”). The patient was treated with surgery (hysterectomy performed on (b)(6) 2015). Essure was withdrawn. At the time of the report, the device dislocation, device breakage, pelvic pain, abdominal distension, headache, anxiety and depression outcome was unknown. The reporter considered device dislocation, device breakage, pelvic pain, abdominal distension, headache, anxiety and depression to be related to essure. Company causality comment: this non-medically confirmed spontaneous legal case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted. She had migration of implant (seen as device dislocation) and fracturing of the implant (seen as device breakage). A hysterectomy was performed to remove micro-inserts around 1 year and half after insertion. Both events are serious due to medical significance and anticipated in the reference safety information for essure. During essure therapy there is a risk that the device could move out of fallopian tubes; this movement could be a dislocation/ migration, or occur as a result of uterine perforation. In the present case, consumer presented migration of implant followed by surgical removal of device. Given the nature of event, a causal relationship with essure cannot be excluded.
If a woman experiences one of these complications, often removal is the only treatment. Thankfully, there are case reports in the medical literature of successful removal surgeries, like this report from 2016:
Case. A twenty-nine-year-old woman G4P4014 presented with a two-year complaint of chronic pelvic pain and dyspareunia after the hysteroscopic placement of an Essure device for sterilization. On reviewing the images of the HSG [hysterosalpingogram], it was noted that although tubal occlusion was confirmed, the left Essure coil appeared curved on itself in an elliptical fashion and did not seem to follow the expected anatomic trajectory of the fallopian tube. The patient reported resolution of chronic pelvic pain following laparoscopic removal of Essure device.
Conclusion. A misplaced Essure device should be considered in the differential diagnosis of chronic pelvic pain in women who had difficult placement of the device. In addition to demonstrating tubal occlusion, careful examination of the configuration of the Essure microinserts on HSG examination provides valuable information in patients with pelvic pain after Essure placement.
Another medical study reviewed the records from 29 patients who had a laparoscopic removal of Essure and found that 10% had adhesions and 17% had endometriosis, but, thankfully, only 7% had post-operative complications after the removal, and none of them needed another operation or another admission to the hospital.