Oklahoma City Essure Attorneys
Knowledgeable, Seasoned, & Experienced
When you chose to undergo a permanent birth control procedure, you likely do so in full faith that it will result in a safe and effective means of preventing pregnancy. What you might not have known is that procedures involving permanent fallopian tube implants such as Essure® have reportedly caused a host of serious side effects and complications in thousands of women, ranging from chronic pelvic pain to death. The Food and Drug Administration (FDA) approved Essure in 2002 and promoted it as a safe and effective method of permanent birth control. It was initially met with great enthusiasm, as it was a non-surgical procedure that could be done in a doctor’s office without general anesthesia, with a virtually non-existent recovery period. However, the FDA approval was based on studies that examined the cases of less than 1,000 women. At the time of approval, it is alleged that the FDA was not aware that Essure was potentially dangerous.
How Does Essure Work?
The Essure birth control device consists of two small coils, made of a polyester-like fiber and a nickel alloy. It is implanted in the fallopian tubes by way of a catheter through the vagina. The coils are designed to induce scar tissue to form that would block the tubes and keep sperm from reaching the eggs, thereby preventing pregnancy. This is a process that may take three months. During that three-month period, an additional form of birth control should be used to avoid pregnancy, to ensure the scar tissue is sufficiently formed to successfully block the tubes. After that, a follow up with a radiologist is required in order to confirm that the fallopian tubes are completely blocked. In order to do so, a dye is injected into the cervix and an X-ray is taken to ensure that no dye leaked past the Essure.
Complications with Essure
Health complications related to Essure are due to the fact that the inserts contain nickel-titanium alloys, a material known to cause allergic reactions. Once the inserts are placed in the body, they release nickel into the tubes, and patients who are allergic to nickel may have serious allergic reactions. Symptoms of a reaction include rash, itching, and hives. If you are currently using Essure and are experiencing these symptoms, you may be in danger of facing detrimental side effects.
In addition to allergic reactions, Essure can cause complications such as:
- Pain/abdominal pain
- Heavier/irregular menstruation
- Weight fluctuations
- Device breakage
Malposition of the Device
The FDA has received over 16,000 adverse-event reports about Essure in recent years. These are official reports concerning symptoms, hospitalizations, or diagnoses that patients, doctors, hospitals or a device manufacturer believe are linked to the device. Among the reports are close to 9,000 surgical removals of Essure, mostly by hysterectomy.
Conceptus Cited for Failing to Conduct Follow-Up Studies
Following clinical trials, the FDA was concerned that test subjects were only monitored for a year or two, while the Essure contraceptive was meant to last a lifetime. The agency approved Essure on the condition that trial participants would be followed for four more years. Of the 269 women involved in the first trial, only 171 were followed for the full five years. Of these, five women required hysterectomies and at least one became pregnant, according to a heavily redacted FDA report. At least 270 adverse events were reported among the cohort, including dozens involving pain and heavy menstrual periods. However, investigators determined that only 17 of these were caused by Essure, which made them conclude that pain and bleeding were rare among users. In the larger trial involving 518 participants, only 366 (approximately 70%) were followed for the full five years. Of these, 15 women had hysterectomies; however, only two were considered to be “possibly” linked to Essure.
Other findings from the trial included:
- 38% experienced unusually heavy periods on a recurring basis
- Nearly one in 25 had recurring pain with intercourse
- One in 20 had had recurrent pelvic pain
- One in 15 had recurrent painful periods
- One woman reported persistent pain
If you or a loved one have been affected by an Essure birth control complication, we encourage you to consult with our team as soon as possible. All initial consultations are free, and we don’t charge any up-front fees for representation. Fulmer Sill handles all fees on a contingency basis, meaning that unless we’re successful, you don’t have to pay us.
You can rely on our tenacious and hardworking team to fight tirelessly for every penny you are owed.