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Essure Birth Control Sales End


Philadelphia medical device lawyers report that Essure birth control device will no longer be marketed.The controversial Essure birth control device will no longer be marketed in the United States. Pharmaceutical giant Bayer recently announced it will no longer sell the device, as of December 31, 2018. This effectively ends all sales, since Essure is no longer available in other countries.

The device, made from flexible coils, is designed to sterilize women after implantation. However, thousands of women have reported complications, including pregnancies, along with the development of autoimmune diseases and the movement of Essure into their abdomen or pelvis. Fatalities, which includes infants, have also been reported.

To date, more than 16,000 users have sued Bayer for medical product liability. However, the company denied that its decision to stop selling Essure had anything to do with the product’s safety, repeating its claims that Essure was safe and effective.

Essure Side Effects

The FDA has received approximately 30,000 complaints since 2002, when Essure was first available in the United States, from both patients and their doctors. Reported side effects included chronic pain, headache, fatigue, tooth and hair loss, miscarriage, allergies, heavy bleeding, uterine perforation, stillbirth, and death.

In 2016, the FDA placed a “black box” warning on Essure’s packaging, stating that the product could move into the pelvic cavity or abdomen and require surgical removal. After the warning was put on the packaging, sales of the product declined by approximately 70 percent, according to the FDA commissioner.

In April of this year, the FDA limited sales of Essure to physicians who guaranteed their patients were informed about the product’s risks. Bayer, however, said the plunge in sales was due to more women using reversible contraception, fewer women interested in permanent contraception, and the “misleading publicity” the Essure device had received.

The FDA commissioner did say that women who currently have the device implanted and are not experiencing problems should not have it removed, unless issues occur, since device removal itself is not without risk.

As of 2018, approximately 750,000 women have had the devices implanted, the overwhelming majority of them United States residents.

Two Small Coils

The Essure birth control device is stunningly simple. It consists of two small, flexible coils derived from a nickel alloy and a fiber resembling polyester. The doctor places the device in the vagina and then into the fallopian tubes. The idea is that the coils create an inflammatory response and scar tissue forms, causing blockage of the tubes so that sperm cannot reach the woman’s eggs.

When it first appeared, Essure was marketed as a nonsurgical alternative to a woman having her fallopian tubes tied to render her permanently sterile.

Philadelphia Medical Device Lawyers at Brookman, Rosenberg, Brown & Sandler Can Assist in Bringing Claims Against Defective Medical Products

If you or a loved one has been injured after using Essure for birth control, you need the services of the experienced Philadelphia Medical Device Lawyers at Brookman, Rosenberg, Brown & Sandler. To make an appointment in our Philadelphia office, call us at 215-569-4000, or contact us online to provide you with legal advice concerning your case today.