Bayer to Pull Essure Birth Control Implant From the Market in the US

According to The Washington Post, the pharmaceutical company Bayer has agreed to stop selling its Essure birth control implant in the United States by the end of 2018. The device has not always been well received by the public; in fact, it has been the subject of many controversial discussions among medical professionals and patients. Many women have claimed that they suffered serious health complications after their Essure devices were placed. These women complained of significant pain, as well as more serious complications, such as perforations of the fallopian tubes and uterus.

Bayer recently stated that taking Essure off of the market was a “business decision” triggered by a drop in sales in the past several years. It has maintained that Essure is safe and effective, and emphasized that women who have received the device need not worry about its safety.

The United States is the only country left that still has Essure on the market. In September of 2017, Bayer stated that it would no longer sell Essure outside of the United States. Bayer, in its announcement, said that the move was for “commercial reasons.”

Essure’s design causes sterilization in women. The device is comprised of two flexible coils made of a nickel and titanium alloy. The coils are about an inch long. In a short, 10-minute procedure, a physician inserts the coil through the vagina and cervix into each fallopian tube. Eggs travel through the fallopian tubes, from the ovaries down into the uterus. For three months after insertion, scar tissue should form around the Essure coils, which blocks sperm from arriving at an egg to fertilize it.

Over the past several years, thousands of women have stated that they suffered from complications such as unintended pregnancies, autoimmune issues, and the migration of the device into the abdomen or pelvis. Some women were forced to undergo surgeries to remove the coils. So far, more than 16,000 patients have filed lawsuits against Bayer.

Angie Firmalino, one of the most vocal advocates against Essure, commented that she was “blown away” by Bayer’s recent announcement. She added, “It took way too long, but we won.” Firmalino, 46, lives in Tannersville, New York and works as a mail carrier.

Firmalino recalled that once she had Essure implanted in 2009, she began bleeding and experiencing pain soon after. Firmalino’s physicians confirmed that the device had migrated to her uterus. Firmalino eventually had a hysterectomy. Firmalino created a Facebook page called “Essure Problems” in 2011, which has reached out to the United States Food and Drug Administration to ban the device. Currently, the Facebook group has around 37,000 members.

According to Bayer, Essure sales in the United States dropped by around 40 percent each year over the last several years. Bayer cited several reasons for such a drop: a decrease in the amount of women using permanent birth control; the increased use of long-term, reversible contraceptives, and “inaccurate and misleading publicity” about the device.

The FDA originally approved Essure in 2002. Many initially praised the device, calling it a nonsurgical substitute to a tubal ligation. Conceptus Inc., which was acquired by Bayer in 2013, developed the product.

Even though adverse reports have piled up in recent years, the FDA has continued to claim that Essure’s advantages outweigh its disadvantages. However, the FDA has noted that there have been serious complications with the device and has required more safety studies and warnings.

In 2016, the FDA told Bayer to place a “black box” on the device’s label. A “black box” is the most severe warning issued by the FDA. Bayer was also instructed to compose a three-page checklist for physicians to use in discussions with patients about potential complications with the device before it was ever implanted.

Early in 2018, patients informed the commissioner of the FDA, Scott Gottlieb, that many patients did not receive adequate warnings regarding the risks of Essure. By April, the FDA had put another restriction on Essure—it would only be sold to doctors who confirmed that female patients were informed about the risks of the coils. The FDA added that Bayer would be responsible for meeting this requirement.

Mr. Gottlieb also released a statement last week, telling women who have Essure that they may continue to use the device without fear if they are not experiencing complications. If a patient thinks the device could be causing issues, she should consult her physician. Gottlieb noted, “Device removal has its own risks.”

Some of those opposed to Essure have criticized the FDA for some time, arguing that it approved the coils based on a weak scientific study. Critics have also said that the FDA should have pursued safety concerns more quickly.

Diana Zuckerman, the president of the National Center for Health Research, said, “The FDA should have required a moratorium on sales and requested that new data be submitted in a much more timely fashion.”

Bayer is headquartered in Whippany, New Jersey, and its property was the site of protests in July. A Netflix documentary that focuses on Essure and other devices, called “The Bleeding Edge,” was showcased. Tess Schulman, 47, a paralegal from Raleigh, North Carolina, had Essure implanted in 2009. However, she began experiencing “strange allergies,” which her doctor ultimately concluded were caused by the Essure. The nickel in the device apparently caused the effects. Once the Essure was removed, her symptoms, such as rashes and fatigue, disappeared.

Around 750,000 Essure implants have been sold, primarily in the United States.

What if a medical device injured me or a loved one?

Medical device manufacturers have a duty to sell products that are safe for consumers. If it is determined that a product is not safe, the manufacturer may be liable for damages in a products liability lawsuit.

A consumer injured by a product, including a medical device, must show the following elements to recover damages:

• The product or medical device was being used as intended or directed;
• The consumer was injured;
• The product or medical device was defective;
• The product’s defect was the direct cause of the consumer’s injury.

Each of these elements must be proven for the consumer to prevail. If one of the elements cannot be supported with evidence, the claim will fail and the consumer will not be entitled to any damages from the manufacturer.

If the consumer prevails, the consumer may be entitled to a number of damages, including:

• Medical expenses, including surgical bills, ambulance bills, physical therapy bills, and related costs;
• The cost of future medical care;
• Lost wages and lost employment benefits;
• Pain and suffering;
• Emotional distress;
• Loss of consortium
• Punitive damages

Other types of damages may also be available, depending on the facts surrounding the claim. To improve the chances of prevailing in a products liability lawsuit, an attorney should be consulted as soon as possible. Without an Essure birth control implant lawsuit attorney, a consumer may unknowingly forfeit any money he or she is entitled to under the law.

Call Parker Waichman LLP today to schedule a free consultation

At Parker Waichman LLP, our Essure birth control injury lawsuit lawyers are experienced in claims of all types, including medical device injury claims. To schedule a free consultation with us, call 1-800-YOURLAWYER (1-800-968-7529) 24 hours a day, 7 days a week.