Essure Lawsuit News: Bill Seeks To Rescind Essure’s FDA Approval And Take The Birth Control Device Off The Market

   

Essure Lawsuit Claims Allege Bayer’s Birth Control Device Causes Serious Harm To Women That Includes Miscarriages, Organ Perforation, And Severe Bleeding, Southern Med Law Reports.

essure-lawsuit-side-effectsEssure Lawsuit News: U.S. Rep. Mike Fitzpatrick has introduced a bill that forces the U.S. Food and Drug Administration (FDA) to rescind its premarket approval of Essure and take the birth control device off of the market. Essure lawsuit complaints allege the birth control system has caused women such injuries as unintended pregnancies, severe bleeding, pelvic and abdominal pain, perforation of the uterus and fallopian tubes, and death.

In introducing the bill, Rep. Fitzpatrick, R-Pennsylvania, said at least five unborn babies and four women have died as a result of Essure. Additionally, the FDA has received 5,000 complaints about the device, which is produced by Bayer HealthCare Pharmaceuticals. Rep. Fitzpatrick said Essure’s failures are “unacceptable” to him and the “Essure Sisters who are living with the device’s effects.”
[patch.com/pennsylvania/warminster/bill-ban-controversial-birth-control-introduced-mike-fitzpatrick-0, Warminster Patch, November 5, 2015]

The FDA approved Essure in 2002 through its 510(k) process in which manufacturers are not required to conduct clinical trials but are required to show that their new device is “substantially equivalent” in safety and effectiveness to similar FDA-approved devices already on the market. 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 tissue prevents insemination, and subsequently, pregnancy.
[fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452250.htm, June 24 2015]

Rep Fitzpatrick’s bill comes at a time when the FDA is considering a proposal by its medical advisory panel to restrict the use of Essure. In October, the FDA’s Obstetrics and Gynecology Devices Panel suggested women who are allergic to metal, have an autoimmune disease, have a history of pelvic inflammatory disease, and a history of abnormal uterine bleeding should not use Essure. The panel also called for a new clinical study to be conducted on Essure’s safety and effectiveness.
[fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials.pdf, FDA, September 24, 2015]

Court documents indicate that pending Essure lawsuit complaints contend the FDA’s premarket approval for Essure is invalid and Bayer should no longer be shielded from product liability lawsuits over Essure. According to the complaints, the FDA’s approval came with a list of conditions, one of which was requiring the manufacturer to inform the FDA of Essure causing or contributing to any serious injury. The Essure lawsuits accuse Bayer of concealing adverse event information about Essure and this invalidates its conditional approval. (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)

Southern Med Law is investigating potential Essure side-effects lawsuits from women, or their loved ones, who believe they have suffered complications from the Essure birth control device. Contact Southern Med Law to learn more about your legal rights. 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.

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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