Efforts To Recall Essure Birth Control Continue After FDA Concludes Its Investigation

   

Essure Birth Control Lawsuits Allege Women May Suffer Heavy Bleeding, Unintended Pregnancies, Miscarriages, Severe Abdominal Pain And Other Complications.

Essure-Birth-Control-Lawsuits-Southern-Med-LawSince the U.S. Food and Drug Administration (FDA) has completed its investigation into Essure, advocates for banning the birth control implant are hoping pending legislation and lawsuits will lead to a recall of the medical device, according to an AZFamily.com report. Essure birth control lawsuits against Bayer, which manufactures Essure, allege that the permanent birth control implant causes life-threatening pregnancies, debilitating pain, hysterectomies, perforation of the uterus and fallopian tubes, and fetal deaths.
[fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm529254.htm]

An AZFamily.com report says women who have suffered injuries from Essure believe the FDA has failed them. However, hopes are resting on Congressional bills aiming to change FDA rules regarding medical devices. For instance, the “Arial Grace Law” calls for amending FDA regulations and hold companies liable for injuries caused by their high-risk medical devices. The measure was named after Arial Grace Burrell who was stillborn in June 2105 due to failure of Essure. One woman interviewed by AZFamily.com said her Essure implant failed when the coils on the device embedded in her uterus “which was twisted 90 degrees.” During surgery to remove Essure, her doctor discovered her ovaries and her left fallopian tube were missing.
[azfamily.com/story/33761577/women-turn-to-congress-courts-to-recall-essure, November 21, 2016]

“There are many women and their babies who have been seriously or fatally injured by Essure. It appears that advocacy will continue until further action is taken on Essure,” says Dr. François Blaudeau, co-founder of Southern Med Law, and a practicing obstetrician/ gynecologist.

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

Essure is a long-term birth control device with two metal coils that are inserted into the fallopian tubes. Scar tissue, which forms around the coils over three months, blocks the tubes and prevents conception. The FDA’s investigation into Essure was spurred by a Citizen’s Petition that called for Essure’s ban due to the device causing such injuries as chronic pain, ectopic pregnancies, miscarriages, and other complications, along with six adult and five fetal deaths. As a result, the FDA held a meeting of its advisory panel in September 2015 over Essure. Five months later, the FDA ordered Bayer to conduct a new clinical study on Essure and place a black box warning on the label about the risks of using Essure. Last week, the FDA approved the updated labeling.
[fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM463486.pdf]

Court documents indicate that Bayer maintains it is shielded from product liability lawsuits over Essure. Recently, however, Essure lawsuits with multiple plaintiffs have been moving forward. For instance, a mass tort was established for Essure complaints in California’s Alameda County Superior Court for 55 Essure cases filed on behalf of 900 women. The complaints accuse Bayer of failing to adequately warn that Essure can spontaneously migrate, perforate organs, and cause severe pelvic pain, heavy bleeding, autoimmune disorders and other complications. (Essure Side-Effects Lawsuits and Coordinated Actions, Judicial Council Coordination Proceeding No. 4887)

About Southern Med Law And Filing An Essure Side-Effects Lawsuit

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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