Essure Lawsuits: FDA Approves Bayer’s Study On Essure Birth Control

   

Essure Lawsuits Allege Bayer’s Birth Control Devices Carries Risks Of Unexpected Pregnancies Abnormal Bleeding, Hysterectomies, And Fetal Death.

Essure-Birth-Control-Lawsuits-Southern-Med-LawAs Essure lawsuits move forward in state and federal courts, the U.S. Food and Drug Administration (FDA) recently approved Bayer’s plan for an updated postmarket surveillance study of its Essure contraceptive device. Bayer’s final report on the study is not due until 2023 but in the meantime, women continue to file lawsuits alleging Essure causes such complications as ectopic pregnancy, chronic pain, bleeding, organ perforation, and even adult and fetal deaths.

“Southern Med Law anticipates the outcome of Bayer’s study and will continue to investigate claims of Essure side effects including hysterectomies, ectopic pregnancies and miscarriages,” says Dr. François Blaudeau, co-founder of Southern Med Law, and a practicing obstetrician/ gynecologist.

Dr. Blaudeau and Southern Med Law continue to speak with women and their families around the country regarding the Essure birth control system and 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 www.southernmedlaw.com to fill out a contact form and receive more information.

On September 2, the FDA approved Bayer’s updated plan that calls for an observational study on Essure involving 2,800 women who will be split into two groups of 1,400. The women will be between 21 and 45 who have not been pregnant within the past six weeks and have chosen laparoscopic tubal sterilization (surgical blocking of the fallopian tubes) or Essure, a non-surgical procedure of inserting the small, flexible birth control device into the fallopian tubes. According to the plan, the study will measure chronic lower abdominal and/or pelvic pain, abnormal uterine bleeding, hypersensitivity and allergic reaction, and invasive gynecologic surgery including Essure insert removal. The study will also measure Essure’s effectiveness at preventing pregnancy
[accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=356&c_id=3854]

In February, the FDA ordered Bayer to conduct a new study of Essure and required the company to place a black box warning on Essure. The FDA’s action came after the federal agency received complaints about Essure and a citizens petition seeking to ban Essure from the market. The FDA said it has received 9,900 reports related to Essure, from November 4, 2002, Essure’s approval date through December 31, 2015. The most frequently reported patient problems with Essure were pain/abdominal pain, menstrual irregularities, headache, fatigue, and weight fluctuations. There were also reports of four adult deaths, 15 incidences of pregnancy loss, and two incidents of a death of an infant after live birth.
[fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm]

Court documents show that Essure lawsuits allege that Bayer invalidated the FDA’s premarket approval of Essure by failing to report side effects such as abnormal bleeding, unintended pregnancies, chronic pain, and allergic reactions to the nickel contained in Essure. Bayer initially asked for Essure cases to be dismissed because the company is shielded from product liability lawsuits over Essure due to the FDA’s premarket approval Essure. However, judges in California and Pennsylvania recently allowed Essure complaints 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)
[modernhealthcare.com/article/20160809/NEWS/160809899]

About Southern Med Law and Filing An Essure Lawsuit Claim

Southern Med Law is an experienced law firm providing legal representation to the men and women across the country who have been 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.

Contact:
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Fax: 205-547-5526
francois@southernmedlaw.com

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