A woman has filed an Essure side effects lawsuit after she says she suffered injuries from the permanent birth control device.

Essure is a non-surgical form of birth control that a doctor can implant during an office visit. Bayer has marketed the product for years as a way for women to obtain permanent results without the down time of a surgical procedure, such as getting the fallopian tubes tied.

Essure is a set of two flexible coils made of plastic-coated metal that are inserted into each fallopian tube via the vagina. The spiky coils are designed to spur the production of scar tissue, creating a barrier between eggs and sperm.

Because Essure does not release hormones, an alternative method of birth control must be used until a doctor confirms at around three months after implantation that the coils have induced enough scar tissue to adequately block the fallopian tubes.

Allegations of Essure Side Effects

Plaintiff Karla A. says she was implanted with Essure in 2015. She says she suffers from severe and permanent injuries because the Essure devices migrated from their implantation point. She says she had to have the Essure coils removed and her fallopian tubes removed as well, causing her to endure severe pain and suffering and emotional distress.

The U.S. Food and Drug Administration (FDA) announced in April 2018 that Essure would undergo a major change to its warning label and require all women considering Essure and their doctors to complete a Patient Decision Checklist to make sure they fully understood the risks.

The checklist warns prospective Essure recipients of the risks of device migration, organ perforation and other side effects that Essure allegedly had not previously disclosed to the FDA, Karla or Karla’s doctor.

According to Karla’s Essure side effects lawsuit, “This patient decision checklist requires a patient’s signature and doctor’s signature, recognizing new risks previously not disclosed.” Karla alleges if she had known of the risks of severe Essure side effects, she would not have had the device implanted.

Karla’s complaints echo those of thousands of women who have undergone Essure implantation. More than 750,000 women have received Essure implants, and the FDA has received more than 32,000 complaints and 10,000 adverse even reports regarding Essure. At minimum, 303 fetal deaths have been linked to the device because of ectopic pregnancies in women who believed they could no longer become pregnant.

The FDA has noted the skills needed to properly implant the coils in their proper positions are beyond those of most gynecologists.

The Essure side effects lawsuit also alleges the representatives of the equipment needed to complete the implantations were not adequately trained, nor did they have sufficient knowledge of the Essure product.

Other reported Essure side effects may be related to the materials. The metal coils contain a nickel-based alloy, and up to 20 percent of the population is allergic to nickel. Women suffering from inflammation, joint pain and rashes could be experiencing an allergic reaction to the nickel. The metals are known to degrade over time, causing metal poisoning as the nickel ions build up in the blood stream.

The plastic coating of the metal coils consists of PET plastic, which degrades and releases toxins at a temperature of 85 degrees or more. Within the human body, that plastic would reach a consistent 98.6 degrees. Chronic inflammation, autoimmune responses, fatigue and extreme joint pain are possible indications the body is reacting to plastic-related poisons.

Bayer has announced it will take Essure off the market by the end of 2018.

The Essure Side Effects Lawsuit is Case No. 181000028, in the Court of Common Pleas, Philadelphia County.