FDA Mandates New Essure Warnings as Lawsuits Move Forward

Drug manufacturer, Bayer is coming under new scrutiny for its non-surgical contraceptive, Essure. Essure is a non-surgical transcervical sterilization procedure approved in 2002 by the FDA and is intended to be a less costly and safer alternative to tubal ligation. During the outpatient procedure, bendable coils are placed into the fallopian tubes, passed from the vagina through the cervix and uterus. Scar tissue then forms around the coils and blocks the tubes from insemination, according to marketing literature provided by the manufacturer.

Bayer has marketed Essure as the latest in women’s birth control and hailed by the drug giant as being safe and effective. However, the United States Food and Drug Administration is responding to growing public pressure and a wave of new litigation, requiring a “black box warning” label to be added to Essure, CNN reports. There have been in excess of 5,000 consumer complaints filed against drug maker Bayer to the FDA, from November 2002 through May 2015. Additionally, a federal judge recently ruled five women alleging harm caused by Essure, can move forward with their lawsuits against Bayer Healthcare.

Combined with the complaints filed with the FDA and various lawsuits across the nation, women and their families are reporting severe pain, organ damage, bleeding, unintended pregnancies, miscarriages, children born with birth defects, and even stillbirths. Some women have undergone hysterectomies, too. All have been implanted with the permanent birth control device, Essure. Clearly, this FDA warning label mandate and lawsuits are intended to demonstrate the international corporation marketed its contraceptive to the public fraudulently.

FDA Mandates New Essure Warnings as Lawsuits move Forward

In another mandate, the United States Food and Drug Administration ordered the corporate giant to conduct a study which will help to determine, “risks of the device in a real-world environment.” The FDA will use the findings of the mandatory study to, “determine what, if any, further actions related to Essure are needed to protect public health,” the Albany Daily Star reports. As part of the mandated study, the drug company is to submit a protocol by or about April 30th. The study must include following 2,000 women over a three-year period. Research subjects will be made-up of women implanted with Essure and women who used other sterilization methods, including surgery.

Over the past several years, the FDA has been examining the growing number of adverse event reports associated with the use of Essure. Reported adverse events include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure failure, and, in some cases, incomplete patient follow-up, have resulted in unintended pregnancies. —U.S. Food and Drug Administration

Moreover, the company is required by the FDA to begin its mandatory real world study within 15 months after submitting its protocol. If the drug maker does not comply with the law and start the study in that time period, the Food and Drug Administration can declare the company misbranded the birth control device, which means the corporation violated Section 502 of the Federal Food, Drug and Cosmetic Act.

Over the past fourteen years, thousands of women have experienced a number of problems after being implanted with the Essure device. Just this year, the United States Food and Drug Administration issued its official updated guidelines regarding health risks and complications associated with the birth control device. It warns women who are seeking permanent birth control could experience infection, tubal blockage, pelvic pain, uterus or fallopian tube perforation, including device migration or movement. The federal agency also warns women might not be able to have additional pelvic electrosurgical procedures after receiving Essure implants.

Rep. Mike Fitzpatrick, Pennsylvania (R) and Madris Tomes, a former FDA contractor and Founder and CEO at Device Events, are sharp critics of the contraceptive; and, while pleased with the progress, remain disappointed the FDA has not done more. “It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market,” Fitzpatrick wrote in a press release. He and Tomes are joined by Rep. Rosa Delauro, (D) Connecticut, who want the device to be taken off the market.

Even if a black box warning is assigned to Essure or it’s eventually removed from the market, several hundred thousands of women are still in harm’s way if they were implanted with Essure permanent contraceptive. Because side effects and problems are not visible, many victims have suffered in silence. But you don’t have to anymore.

If you or a loved one has experienced any health complications or conditions after being implanted with the Bayer Essure device, it’s important to share your story. It’s also important you immediately speak with an experienced legal professional to learn about your rights and if you might be entitled to compensation.

By | 2018-05-26T12:39:03+00:00 May 13th, 2016|Products Liability Law|0 Comments

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