Essure Procedure Complications Continue To Grow

Essure Procedure Complications Continue To Grow

Introduction

The United States Food and Drug Administration (FDA) released data on May 17 regarding Essure birth control implant stating that there is a significant growth in the number of complications suffered by the women after undergoing the implant procedure.

Earlier, Bayer announced a $1.6 billion settlement to resolve thousands of Essure lawsuits and two years ago the company even recalled the product from the U.S. market.

The data provided by the manufacturer states that the company reported at least 33,097 cases which included 19 deaths due to the complications of the Essure procedures. Federal regulators warned that even though some of these incidents may be duplicates, the long-term risks associated with the implant cannot be ignored as cautioned by the data provided.

Bayer marketed the Essure procedures as safe and effective for permanent birth control. The implant had flexible coils which are inserted into the fallopian tubes during the procedure which prevented insemination. Later, the company removed the device from the market considering the thousands of lawsuits claiming the painful and debilitating injuries to the users.

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.

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 their injuries such as perforation of the fallopian tube, neurological damage, and severe pain. In some cases, women died from complications.

Bayer submitted data to the FDA which reported the most common problems because of Essure including pain, perforation of organs, pregnancies, heavier periods and even breaking down of the parts in the body.

Worldwide 750,000 women implanted the device of which 70% of the women are from the U.S. It is expected that Bayer will face more Essure litigations in the future.