The FDA has imposed a new limitation on the sales of Bayer’s Essure birth control, ensuring Essure patient information is distributed before a woman undergoes the procedure.

The FDA says this “unique type of restriction” puts Essure into the hands of only those doctors who provide patients with a checklist of risks that the doctor must sign when done presenting the risks. The patient will have the option to sign the notice, as well.

The checklist has been on Essure’s label since 2016, but the FDA believes some women have been unaware of the risks before being implanted with the permanent birth control system.

“That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks,” said FDA Commissioner Scott Gottlieb in a statement released April 9.

The FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement” paperwork is a restriction that Bayer needs to enforce immediately. The FDA indicated that failure to implement the new Essure patient information dissemination procedure will result in the agency taking “appropriate action for a failure to comply, including applicable criminal and civil penalties.”

Why Essure Patient Information Matters

Essure birth control system is a permanent, non-surgical sterilization procedure for women that was approved by the FDA in 2002.

The mechanism consists of two tiny stainless steel coils coated by a nickel alloy. The coils are covered in small plastic fibers designed to produce a fibrotic reaction when inserted into the fallopian tubes. Three months of scar tissue production is supposed to form a barrier between the sperm and eggs.

Since 2016, Essure has included a black box warning on its label regarding the most serious risks of the procedure, which include the coils perforating the uterus or fallopian tubes.

Bayer has faced lawsuits from more than 16,000 women who allege they have suffered myriad side effects from Essure. Numerous case blocs in California and Pennsylvania are in courts right now.

Among the alleged adverse effects from Essure are:

• Debilitating pain in the ovaries or uterus
• Headaches
• Irregular bleeding
• Device migration
• Nausea
• Flu-like symptoms
• Joint pain
• Rashes
• Muscle weakness
• Abdominal pain
• Painful intercourse
• Back pain
• Heavier periods

According to the Essure patient information, rashes and itching have been linked to a nickel or other metal allergy in some women, even if a prior sensitivity test showed no proof of such an allergy.

The Essure patient information also indicates the original premarket studies showed the rate of perforation of the uterus or fallopian tubes was 1.8 percent, but does not indicate postmarket numbers.

“The rate for an insert being found in the abdomen or pelvis has not been determined but its occurrence is uncommon,” says the Essure patient information page.

Bayer released its 2016 annual report, which showed $413 million in losses related to Essure. Despite the birth control mechanism’s drain on profits, the German-based pharmaceutical company reported a net income of $4.8 billion.

If you have suffered Essure birth control problems and believe you were not given complete Essure patient information before making your decision, you could benefit with speaking to a lawyer about your legal options.