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 was 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 other complications including:
- 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 2, while the Essure contraceptive was meant to last a lifetime. The agency approved Essure on the condition that trial participants would be followed for 4 more years.
Of the 269 women involved in the first trial, only 171 were followed for the full 5 years. Of these, 5 women required hysterectomies and at least 1 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 (app. 70%) were followed for the full 5 years. Of these, 15 women had hysterectomies; however, only 2 of were considered to be ‘possibly’ linked to Essure. Other findings from the trial included:
- 38% EXPERIENCED UNUSUALLY HEAVY PERIODS ON A RECURRING BASIS
- 1 IN 20 HAD HAD RECURRENT PELVIC PAIN
- 1 IN 15 HAD RECURRENT PAINFUL PERIODS
- NEARLY 1 IN 25 HAD RECURRING PAIN WITH INTERCOURSE
- 1 WOMAN REPORTED PERSISTENT PAIN
DO YOU NEED HELP WITH A POTENTIAL ESSURE BIRTH CONTROL CLAIM?
When you have your future on the line, you cannot afford to put your trust in an inexperienced attorney. Instead, you need to seek the guidance of attorneys who have extensive experience and resources to either reach a favorable settlement or win your case at trial. We have done both on behalf of our clients on numerous occasions. At Fulmer Sill, we are proud to deliver high-quality assistance to all of our clients. Should you choose to seek our legal representation, we are confident that our experience and knowledge will produce a favorable outcome for you. If you or a loved one have been affected by a 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. Please contact us at (405)510.0077 for a free consultation.