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FDA Places New Sales Restrictions On Bayer’s Essure Contraceptive Implant

On April 9th, the Food and Drug Administration (FDA) announced it would require Bayer to restrict sales of its Essure birth control implant to medical practices that agree to fully inform women about the risks associated with the device.

During the 16 years that the implant has been around, thousands of women have sued Bayer, the company that manufacturers Essure. Many of these women claimed they suffered severe injuries, including perforation of the uterus and the fallopian tubes from the metal implant.

A couple of years ago, the F.D.A. decided not to pull the device off the market, and instead ordered a “black box warning” to be placed on the product’s package. The warning states the injuries that can be caused by the device and notes how the implant can potentially travel into a woman’s abdomen and pelvic cavity, which can cause pain and might require surgical removal.

The device contains two small coils that are made of a nickel alloy and a polyester-like fiber. Essure is placed in the fallopian tubes through the vagina and is supposed to create an inflammatory response that causes scar tissue in the area to form and block the tubes.

According to the FDA, from the time that Essure was first approved, thorough December of 2017, the agency received 26,773 reports of adverse complications related to the device. However, some of these reports could possibly be duplicates.

The F.D.A. says that most the common problems reported were pain, menstrual irregularities, and headache. Many of the reports listed multiple conditions experienced by individual patients. Additionally, there were reports of deaths, lost pregnancies, ectopic pregnancies, and other serious health issues.

Speaking on behalf of Bayer, spokesperson Steven Immergut said that around 750,000 devices had been sold worldwide. He says the company has “experienced a decline in sales due to the broad dissemination of misleading and inaccurate information on social media that is influencing women’s choices.”

The commissioner of the FDA, Dr. Scott Gottlieb, met in February with a group of women concerned about continuing injuries connected to the Essure birth control device. Some of the women in the meeting demanded that the device be taken off the market, while others wanted a stronger warning put on the product.

Holly Ennis, a lawyer representing hundreds of women who are suing Bayer over the device, said “One of our other large concerns is that women who got Essure had no idea there was a warning on the device, or a doctor-patient discussion checklist.”

The FDA’s recent action will require doctors to have their patients sign a form with a checklist acknowledging that they have been adequately advised about the implants’ risks. The checklist must also be signed by the physician.

Bayer has since released a statement saying that it issued a new label for the birth control device that suggests health care providers should discuss the device’s risks with patients. According to Bayer, The benefit/risk profile of Essure has not changed and remains positive.”

Have you suffered a serious injury caused by an Essure birth control device? The lawyers at Pratt Clay, LLC can help you. We have recovered more than $80 million on behalf of our clients and we are ready to put our skills and resources to work for you. Contact our Atlanta team of product liability lawyers to set up a free consultation today.