Essure

  • Essure

Conceptus Inc., a subsidiary of Bayer AG, developed Essure which is a Class III device for permanent surgical sterilization in women. Essure was approved by the Food and Drug Administration (FDA) on November 4, 2002. The device has two metal coils made from polyester fibers, nickel-titanium, stainless steel, and solder which are placed in fallopian tubes to induce fibrosis and block the fallopian tubes to prevent fertilization. Since 2002, it is estimated by Bayer that 750,000 women have received the Essure IUD.

Advantages of Essure as marketed by Bayer

  • Less Anaesthesia

  • Less Time Procedure

  • Less Invasive

  • Cheaper

  • Highly Effective

Essure's warning label had noted that the device's nickel can result in allergic reactions, such as itching and hives but in reality, women were found to suffer permanent injuries including autoimmune diseases, perforated organs, and severe pelvic pain. From November 4, 2002, through May 31, 2015, around 5,093 reports of problems connected to Essure were filed with FDA.

While the device’s manufacturer claims Essure is safe and effective, thousands of women disagree. They say the metal coils caused them injuries such as perforation of the fallopian tube, neurological damage, and severe pain. In some cases, women died from complications.

Serious Alleged Injuries may include:

  • Severe Abdominal pain and bloating
  • Severe Pelvic pain
  • Device displacement
  • Device breakage
  • Heavy menstrual periods
  • Weight fluctuations
  • Allergies to Nickel
  • Chances of ectopic pregnancy
  • Permanent Removal of Uterus
  • Perforation of the uterus or fallopian tubes

FDA SAFETY WARNINGS:

In September 2015, the FDA held a meeting to examine the safety of the product after receiving thousands of adverse event reports.

On October 31, 2016, the FDA issued a final guidance, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” after carefully considering public comments.

On November 11, 2016, FDA announced label changes adding a boxed warning and a Patient Decision Checklist. This was aimed to support patient counseling and understanding of risks and benefits associated with Essure, as well as what to expect during and after the Essure procedure.

Lawsuit Allegations:

So far, Essure litigation continues with individual lawsuits in various state courts.

Lawsuits filed against Bayer claim several legal actions against the drugmaker including designing a faulty product, negligence, failure to warn the public about the health risks, breach of implied and express warranty, fraud, willfully concealing the dangers of Essure, misrepresenting the safety and effectiveness of Essure and improperly training doctors on how to use Essure. The lawsuits allege that Conceptus violated the terms of the FDA’s premarket approval and committed fraud by withholding data from the agency.

The California Essure lawsuits are under Judicial Council Coordinated Proceedings (JCCP), which will facilitate efficient adjudication and coordinate efforts on behalf of the plaintiffs, and presided by Superior Court Judge Winifred Y. Smith.

In 2017, the company reports quoted a loss of about $413 million in revenue in 2016 because of Essure lawsuits and was facing about 3,700 lawsuits.

To date, there have been no Essure lawsuit settlements.

Evidences:

  • Usage of Essure Device in operative records.
  • Product identification (Implant sticker) in the medical records.
  • Proof of Injury in Medical Records.
  • Treatment provided for the injuries.

Medical Record Review and claim validation of Essure case should take approximately 2 hours in most instances; however, this approximation may vary in cases based on the volume of records.

Accreditations

HIPAA

Neural IT has successfully implemented HIPAA for securing Health records....

ISO 27001 Certification

Neural IT has successfully passed the ISMS re-certification audit and is now ISO 27001:2013 certi...

NSIC - CRISIL

NSIC-CRISIL has assigned a "SE 2A" rating to Neural IT, indicating a company with High Performanc...

Associations

CAALA

CAALA - "Neural IT is proud to be associated with CAALA (Consumer Attorneys Association of Los An...

CAOC

CAOC - "Neural IT is proud to be associated with CAOC (Consumer Attorneys of California) as a Ven...

NYSTLA

NYSTLA - "Neural IT is proud to be associated with NYSTLA (New York State Trial Lawyers Associati...

News & Events

‘Rewards & Recognition Program’ Celebrations
‘Rewards & Recognition Program’ Celebrations!
Hurricane Relief Fund
We donated to Hurricane Relief Fund and got a signed ball from Kareem Abdul-Jabbar, the greatest
AAJ Annual Convention 2017
Neural IT sponsored TRT meeting was one of the active participants of AAJ Annual Convention 2017.

Latest Tweets