Essure Cases Get the Go Ahead in California

Dallas, TexasThere was big news out of California this month for women that have suffered serious injuries after having a small metal-spring-like metal device, known as Essure, implanted in their fallopian tubes to prevent pregnancy.

On August 2, 2016, a Superior Court of California judge ruled 14 women, who live in state of California, can proceed with litigation against Bayer, the maker of the device.

Bayer had argued vigorously against any attempt to bring litigation forward against Essure. The pharmaceutical giant maintained that Essure was immune to legal action under federal pre-emption law that shields Class III medical devices which have been approved by the FDA, from lawsuits.

The devices first came on to the market in 2002. Since then an estimated 750,000 women in the US have opted to use Essure as a method of sterilization.

Tiny metal coils are inserted through the vagina, through the cervix and into the fallopian tubes. Over a period of several months, scar tissue builds up around the coil and blocks the transportation of eggs from the ovaries to the uterus and prevents pregnancy.

Bayer aggressively markets the devices as a low-cost, safe, hormone free and effective birth control procedure that can be performed in the doctor’s office. In as little an hour, the patient can be on her way home.

In some states, the procedure is offered to women at no cost.

“It was touted and marketed as an effective means of preventing pregnancy,” says Dr. Shezad Malik, a Texas physician and attorney who represents clients involved in medical litigation. “However, for the last several years there have been issues that cause the device to migrate and perforate the fallopian tubes. There have also been ectopic pregnancies (pregnancies that develop in the fallopian tubes) plus reports of the coils perforating the uterus.”

“There have also been severe allergic reactions, infections, pelvic disease, abdominal pain and other problems,” says Dr. Malik.

The coils contain a tiny amount of nickel and some of the complaints related to Essure relate to adverse reactions to the metal.

“It can be hard to test for a nickel allergy,” says Dr. Malik, from the Dr. Shezad Malik Law Firm. “A lot of women do not know they are allergic to nickel at the time the Essure device is inserted.”

Close to 1,000 adverse events related to Essure inserts have been reported to the FDA over the last 14 years. Hundreds of women with complaints about Essure have banded together calling themselves “E-Sisters” and regularly post information on social media sites.

“These complications can be very expensive,” says Dr. Malik. “Women can end up with skyrocketing medical bills that someone has to pay.”

The so-called E-Sisters have complained vigorously about the federal pre-emption law that has precluded legal action. The California decision will enable women from California to go forward, but there still is a longer road ahead for women outside California.

“Everyone else will have to file a federal claim and there is a motion underway to try to get these cases federalized in an MDL (multi district litigation) right now,” says Dr. Malik.

Bayer has consistently defended its product as safe and effective. Earlier this year the senior vice-president and head of medical Americas at Bayer, Dario Mirski, M.D., issued a statement saying, "Patient safety and appropriate use of Essure are our greatest priorities," and "a woman's decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about Essure."