Essure – Emerging Litigation

Essure – Focus Blocks

Essure is a permanent, less-invasive surgical sterilization procedure for women.  With Essure, a coil designed to induce fibrosis and block the fallopian tubes is placed into each fallopian tube to prevent fertilization. The manufacturer Conceptus Inc., a company owned by Bayer failed to warn of side effects including chronic pain, puncturing of the uterus and/or fallopian tubes, stomach and pelvic device migration, abnormal bleeding, and unplanned pregnancy. Had the manufacturer warned of the risks, patients might have chosen a different form of birth control e.g. hysterectomy, salpingectomy, tubal ligation, tubal fulguration, or application of clips.

essure

Manufacturer: Developed by Conceptus Inc., a subsidiary of Bayer AG.

 

Device Description: The system consists of two metal coils that doctors implant in each fallopian tube.

 

Mechanism Of Action:

 essure2

The insert contains inner polyethylene terephthalate fibers to induce inflammation, causing a benign fibrotic ingrowth, and is held in place by flexible stainless steel inner coil and a dynamic outer nickel titanium alloy coil. Once in place, the ingrowth continues over a period of three months, resulting in durable occlusion or blockage in the Fallopian tubes; the tissue barrier formed is supposed to prevent sperm from reaching an egg. During that intervening three month period, women are advised to use an alternate contraceptive method.

 

Approval: By FDA it was approved for use in the United States on November 4, 2002.

 

Serious Risks:

  • Perforation, expulsion, or other unsatisfactory location of the insert
  • Punctured uterine walls
  • Pregnancy and increased risk of ectopic pregnancy
  • Pain, cramping, vaginal bleeding, menstrual pattern changes, light periods at first then longer, heavier periods lasting up to 6–8 weeks due to changing birth control methods to a non-hormonal solution
  • Nausea/vomiting
  • Vasovagal response (fainting)
  • Allergic reaction to the materials
  • Heightened allergic response to other allergens
  • Heavy metal toxicity
  • Itchy, raised rash
  • Brain fog
  • Autoimmune disease symptoms
  • Weight gain
  • Anxiety/depression
  • Hair loss
  • Severe anxiety
  • Numbness of extremities
  • Joint pain
  • Back pain
  • Suicidal thoughts

 

CASE REVIEW FOCUS AREAS:

1.Was Essure placed?

a.Were there any doctor notes of complications during placement?
b.Were there multiple attempts to place the Essure?

2.Did the patient have any preexisting conditions, allergies or contraindications for the device?

3.Past medical history - Any prior IUD placement, OB/GYN medical issues from history?

E.g.: Past Medical History: Conditions affecting genito-urinary tract.

4.Need for Essure placement?

5.Was she a right candidate for Essure placement?

a.Did she have a prior pregnancy?

b.Were there at least 6 weeks between prior pregnancy and Essure placement?

6.Did the patient develop Complications after Essure placement?

a.Were there any complications immediately after placement?

7.Treatment/management – Operative procedure, indications, complications, pathology and findings of side effects.

8.Follow-up visits for side effects or complications

a.Was there an X-ray/ultrasound 3 months after placement to confirm that the Essure was properly placed?

9.Complications of Essure use:

Specific Focus:

Identify and report cases with the following scenarios:-

  1. No Injuries: Patient had Essure treatment, but did not develop any complications

Missing record communication:

Identify and report on missing medical records

Apart from identifying critical missing records that are important for the case, provide a detailed outline on what records are needed, why we need them, how did we get a clue that these records are missing and whether the records missing are confirmatory/probable. This will also help in following up and retrieving the records.

Missing Records are presented in the following format

What Records/Medical Bills are NeededHospital/

Medical Provider

Date/Time PeriodWhy we need the Records/BillsIs Record Missing Confirmatory or Probable?Hint/Clue that records are missing