Essure Lawsuits Review FDA Order To Display Black Box Warning On Birth Control Device

   

Essure Lawsuits Claim Birth Control Device Causes Punctured Organs, Chronic Pain, And Unintended Pregnancies After Bayer Failed To Warn About of Risks

Essure-Birth-Control-Lawsuits-Southern-Med-LawAfter receiving complaints about Essure and petitions to take the birth control device off the market, the U.S. Food and Drug Administration (FDA) instead decided to require a black box label warning about the risks of using Essure. While FDA investigated Essure side-effects, women and their families have been filing Essure lawsuits claiming the birth control device causes serious side effects such as excessive bleeding, pelvic pain, abdominal pain, unintended pregnancies and puncturing of the uterus and other internal organs allegedly after having the birth control device implanted.

In a news release issued on Monday, the FDA said it ordered Bayer, Essure’s manufacturer, to conduct new studies that assess the device’s risks in different groups of women. The study will include the rates of complications, such as pelvic pain, additional surgery to remove the device, and how much these complications affect a woman’s quality of life. The regulatory agency also issued a draft guidance that includes a checklist for doctors on what to discuss with their patients to help them make informed decisions prior to having Essure implanted.
[fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm488313.htm, FDA, February 2016]

“The FDA’s decision may come as a disappointment to many women who have petitioned the agency and urged the FDA panel members in September to recommend taking Essure off the market,” says Dr. François Blaudeau, a founding partner of Southern Med Law, and a practicing attorney and obstetrician/gynecologist, who strongly advocates for and represents women in Essure lawsuits.

The attorneys at Southern Med Law are investigating potential Essure side-effects lawsuits from women who believe they have suffered complications from the Essure birth control device. You can arrange for a free, no obligation legal consultation to learn more about your legal rights. Call Southern Med Law today, at (205) 547-5525 or you can visit www.southernmedlaw.com to fill out a contact for and receive more information.

The FDA approved Essure in 2002 and since that time, received more than 5,000 adverse events reports about the device. Essure is a small device with flexible coils that is inserted into the fallopian tubes. Once in place, scar tissue forms around the coils after about three months. The build up of scar tissue creates a barrier that keeps sperm from reaching the eggs, and prevents conception.

In October, an FDA panel made several suggestions including restricting Essure’s use, particularly for women who have a hypersensitivity to metal, autoimmune disease, history of pelvic inflammatory disease, and a history of abnormal uterine bleeding. However, U.S. Rep. Mike Fitzpatrick called for more drastic action in November by introducing a bill that, if passed, would require the FDA to rescind its premarket approval of Essure and recall the medical device.
[fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM464487.pdf, September 24, 2015]
[patch.com/pennsylvania/warminster/bill-ban-controversial-birth-control-introduced-mike-fitzpatrick-0, Warminster Patch, November 5, 2015]

Court records show Bayer is facing five Essure lawsuits that allege the company invalidated the FDA’s premarket approval for Essure by concealing the side effects of severe bleeding, chronic pain, unintended pregnancies and other health complications. The Essure complaints also contend that Bayer should not be shielded from product liability lawsuits over Essure. Bayer denies the allegations and has asked to have the five cases dismissed.(Case No. 2:14-07315, 2:14-07316, 2:14-07317, 2:14-07318, 2:15-00384, U.S. District Court, Eastern District of Pennsylvania)

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
http://www.southernmedlaw.com

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