Study Confirms Problems With Essure Contraceptive Implant

On April 24, 2015, a long overdue medical report was published by several experts detailing the long-term effects of the contraceptive implant known as Essure. Despite being once heralded as one of the safest and least-invasive options for women wishing to forgo further childbearing, the dangerous reality of the device has led many women down a path marked with pelvic pain, difficult menstrual periods, perforation of surrounding organs, and – in some cases – the need for invasive revision surgery.

As series of Essure lawsuits has hit federal and state dockets across the U.S., with many women seeking seven figures in financial compensation.

Problems with Essure

The Essure device was originally marketed by Conceptus, Inc. (and later by Bayer Pharmaceuticals) as a safer alternative to surgical sterilization that required less recovery time and a reduced risk of infection and scarring. The implant is made of a combination of metal and polyester, and is fashioned like a coil for insertion directly into the patient’s fallopian tubes. The presence of the Essure device is calculated to induce the development of scar tissue, which is to theoretically block the possibility of sperm reaching an ovum.

However, many women implanted with the Essure device have found it does more harm than good, and have alleged the following complications with the device:

• Severe back pain
• Pelvic pain and pressure
• Heavy & prolonged menstrual periods
• Migration of metal coils through the Fallopian tubes and into surrounding organ tissue

Moreover, data reveals that the Food and Drug Administration was inundated with over 16,000 complaints from patients injured by the device, which is actually sold in 23 nations worldwide. In a study purported to follow 518 women implanted with the Essure device, 21 women experienced a perforation of the fallopian tubes, while eight women had to endure invasive traditional sterilization surgery or surgical removal of a wayward coil. In total, as many as 750,000 women are believed to be implanted with the Essure device, making growing number of Essure claims virtually inevitable.

Comparison with Mirena IUD complications

The Mirena IUD is undergoing similar scrutiny as several lawsuits are already underway questioning the integrity of Bayer Pharmaceuticals for promoting the contraceptive device as safe and essentially risk-free. Much like Essure, the Mirena IUD is implanted vaginally within the confines of a gynecologist’s office – and it does not require an invasive procedure or a lengthy recovery. Unlike Essure, the Mirena IUD is implanted directly into the uterus and is designed to essentially “trick” the body into believing a pregnancy is underway, thereby ceasing the ovulation process.

In both cases, the devices have been alleged to migrate from their intended positions, causing painful uterine perforation and lodging into surrounding pelvic organs. However, unlike Essure, Mirena is intended as a non-permanent contraceptive measure and can be removed to help resume fertility.

Product liability claims involving both Essure and Mirena will hinge on the notion that manufacturers knew – or should have known – that the implantations could cause serious complications yet they failed to warn patients of this risk.

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