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Essure® is a device developed by Conceptus Inc., a subsidiary of Bayer AG useful for permanent surgical sterilization in women, and was approved by FDA in 2002. It has two metal coils made from polyester fibres, 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
- 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, 5,093 reports of problems connected to Essure are been filed with FDA.
Major complications faced till date:
- 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
Food and Drug Administration announced on 29 February 2016, it will make Bayer add a Black box warning as its most serious type to alert doctors and patients to problems reported with the nickel-titanium implant. Also Bayer is asked to conduct a post-market surveillance study to obtain more data about Essure's benefits and risks.
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, wilfully concealing the dangers of Essure, misrepresenting the safety and effectiveness of Essure and improperly training doctors on how to use Essure.
Evidence to be looked for in potential cases
- 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.