Essure Side Effects And Allegations of Misconduct Focus of Meeting With FDA


Southern Med Law Represents Women In Essure Side Effects Lawsuits Alleging Failure To Warn Of Uterine Bleeding, Miscarriages And Hysterectomies.

Essure-Birth-Control-Lawsuits-Southern-Med-LawAs filings of Essure side effects lawsuits continue in state and federal courts nationwide, representatives from a grassroots movement, the Essure Problems Members, met with the FDA to try and get Essure off the market. The recently meeting with staff from the U.S. Food and Drug Administration (FDA) comes after a ruling in California has allowed 14 Essure lawsuits to move forward. The Essure birth control lawsuits allege Bayer’s contraceptive device causes complications such as miscarriages, ectopic pregnancy, chronic pain, hysterectomies and even fetal death.

“Southern Med Law commends the Essure Problems members for asking and getting answers, as much as possible, on the actions the FDA and Bayer are taking on Essure side effects,” says Dr. François Blaudeau, co-founder of Southern Med Law, and a practicing obstetrician/ gynecologist.

Southern Med Law provides the latest information on Essure birth control as the law firm is currently representing numerous women in multiple medical device lawsuits involving Essure side effects. You can arrange for a free, no obligation legal consultation to learn more about Essure lawsuits and injuries by calling Southern Med Law to speak with one of our experienced attorneys at (205) 547-5525 or you can visit to fill out a contact form and receive more information.

According to the Essure Problems website, the FDA fielded questions for one hour that ranged from the time frame for implementing the agency’s black box warning regarding Essure, to allegations of misconduct and changes of records during Essure clinical trials. The FDA has said it did not find evidence of any intentional changing of information in the clinical trials. The Essure Problems members also reported that the FDA is “currently not pursuing regulations for Essure.” However, within the agency’s “final guidance” or recommendation to Bayer is its most strongest warning, called a black box warning, and a Patient Decision Checklist.

In September 2015, the FDA held a public hearing on the safety and efficacy of Essure, a long-term birth control system the agency approved 14 years ago. After reviewing feedback from the public hearing and recommendations from its Obstetrics and Gynecology Devices Panel, the FDA ordered Bayer to conduct a study to obtain more information about Essure’s benefits and risks. The FDA also issued a draft guidance for public comment on the proposed language to be included in warnings regarding hysteroscopic sterilization devices such as Essure. According to the Essure Problems website, the FDA has receive over 1,300 comments that need to be reviewed before the agency finalizes the guidance document.

According to court documents, Essure side effects lawsuits are being filed against Bayer on behalf of women who have been implanted with the contraceptive device and allegedly suffered complications as a result. Bayer has contended that the company is protected from product liability lawsuits involving Essure because the birth control device received premarket approval from the FDA. However in recent months, Bayer’s request to dismiss Essure lawsuits have been denied. In July, a California state court judge allowed 11 consolidated Essure birth control lawsuits filed by 14 women to move forward against Bayer. Also, a federal court judge in the Eastern District of Pennsylvania allowed Essure lawsuits to move forward on failure to warn and negligence claims. (Essure Birth Control Lawsuits Case No. 2:14-07315, U.S. District Court, Eastern District of Pennsylvania)

About Southern Med Law And Filing An Essure Birth Control Lawsuit

Southern Med Law is a patient and consumer advocacy organization providing legal representation to the victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.
Southern Med Law

Southern Institute for Medical and Legal Affairs
2224 1st Ave., North
Birmingham, AL 35203
Phone: (205) 547-5525
Fax: (205) 547-5526

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