New Surgery for Essure Removal Relieves Device-Related Pain in Patients | Levin Papantonio Rafferty - Personal Injury Law Firm

New Surgery for Essure Removal Relieves Device-Related Pain in Patients

The Journal of Robotic Surgery published results of a study touting a new robotic-assisted surgical approach for the removal of Essure, a medical contraceptive device designed as an alternative to tubal ligation.

How the Study Was Conducted

The purpose of the study was two-fold:

  1. Assess the safety and feasibility of robotic-assisted procedures for removal of Essure implants
  2. Evaluate whether the surgeries yielded improvement in symptoms for patients

Via phone surveys, researchers documented pain scores and quality-of-life ratings for 21 women who would undergo the robotic-assisted removal of Essure devices.

The mean time for the surgical removal of the implants was 5.3 years from the time of placement. Surgeries lasted a mean time of around 43 minutes, with a mean length of stay of 11 hours. The procedures resulted in no complications.

Conclusions Regarding Effectiveness for Addressing Symptoms

When compared with pain scores taken before the surgeries, the pain level reported by patients improved from a score of 8.5 (highest score being 10) before the procedure to a score of 0.75 after the surgery. The mean quality of life scores also improved—from 5.9 (highest score being 7) before the surgical removal of the device to 1.5 one month following surgery.

Researchers concluded that “robotic-assisted laparoscopic Essure removal appears safe, feasible, and potentially superior to other surgical approaches.”

“Robotic-assisted laparoscopic Essure removal appears effective in treating pain and various other symptoms attributed to Essure devices.”

The Need to Remove a Permanent Implant

Although Essure was intended to exist as a permanently implanted female birth control device, women have begun reporting problems with the implants. According to the U.S. Food and Drug Administration (FDA), some of the short-term risks associated with the device include:

  1. Pain (mild to moderate) during the implantation and immediately following the procedure
  2. Vaginal bleeding, dizziness, cramping, vomiting, pelvic/back discomfort, and dizziness right after the procedure

The agency also reports longer-term risks to patients who receive Essure implants, such as:

  1. Unintended pregnancy
  2. Pelvic, abdominal, or back pain
  3. Implants travel to the pelvic or abdominal cavity
  4. Perforation or tearing of the uterus or fallopian tubes
  5. Allergic reactions or hypersensitivity
  6. Additional surgeries required after removal of the device

The FDA reported other reactions from Essure, including:

  1. Fatigue
  2. Headache
  3. Depression or mood changes
  4. Weight changes
  5. Hair loss

The FDA cautions women that around eight percent of patients who receive Essure implants cannot rely on the device for effective contraception.

FDA Actions Against Essure

After hearing expert opinions and learning of patient experiences with Essure during a 2016 meeting with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, the FDA ordered Bayer (the makers of Essure) to conduct a post-market surveillance study into the benefits and risks of the birth control device.

In November of that same year, the FDA required black box warnings be placed on Essure packages to warn patients and doctors of the risks.

The FDA finally restricted sales of Essure in 2018. Only doctors who agreed to review a checklist of potential issues with patients prior to implantation could purchase the medical devices.

Bayer announced in July 2018 it was ceasing sales of Essure by the end of 2018.

Essure-Related Lawsuits

Essure makers Bayer and Conceptus Inc. eventually faced nearly 39,000 claims from patients who endured severe abdominal damage when their implanted devices moved and punctured their uterus or fallopian tubes.

Claimants based their claims of personal injury on the fact that had they known of the risks associated with Essure, they would have selected some other form of birth control.

In August 2020, Bayer announced its plan to pay $1.6 billion to end almost all of the U.S. Essure-related lawsuits against the company.