Five Essure Lawsuits Allege Bayer Concealed Adverse Event Information Associated With Essure, Including Organ Perforation And Spontaneous Migration Of The Birth Control Device, Reports Southern Med Law

Birmingham, AL -- (ReleaseWire) -- 07/21/2015 --Federal judges are set to rule on whether Bayer can continue to be shielded from Essure product liability lawsuits that allege such side effects as pelvic pain, organ perforation and unintended pregnancies due to the birth control implant. Court records indicate that Bayer Healthcare Pharmaceuticals has asked for a dismissal of five Essure birth control lawsuits filed in the U.S. District Court, Eastern District of Pennsylvania. The birth control lawsuits contend the U.S. Food and Drug Administration's (FDA) premarket approval for Essure is invalid because Bayer failed to report adverse events caused by the contraceptive to the FDA, and Bayer's protection from product liability lawsuits over the birth control devices should be removed.

Bayer stated in its July 2 omnibus motion that Essure was approved through the FDA's premarket approval (PMA) process in November 2002 and plaintiffs "can point to no document which says the Essure PMA is invalid. That is because none exists." Bayer also contends in its brief that the FDA has not required "a recall or additional warnings on the device, and has certainly not concluded that the PMA for Essure should be withdrawn as Plaintiffs argue should occur here." (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)

"Our law firm is currently representing women from around the country in product liability lawsuits, so we wait in anticipation for the rulings in these complaints," says Dr. François Blaudeau, founder of Southern Med Law.

Dr. Blaudeau possesses a unique understanding of the medical and legal fields as he is also practicing obstetrician/ gynecologist and can answer questions relating to Essure. If you or a woman you love are believed to 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 by calling Southern Med Law today, at 205-547-5525 or you can visit https://www.southernmedlaw.com to fill out a contact for and receive more information.

As stated by the FDA and court documents, Essure is a form of long-term birth control. During the implant procedure, two bendable metal coils are inserted into the fallopian tubes, passing through the vagina, cervix and uterus. The process causes scar tissue to form around the coils over several months, which blocks the tubes and prevents conception. The FDA stated in June that the agency has received 5,093 adverse event reports over Essure from the time the device was approved in November 2002 to May 31, 2015. According to the FDA, migration of the device or one of its components and device breakage were among the most frequent problems reported, while abdominal pain, menstrual irregularities and headache were among the most frequently reported side effects. The federal regulator also received five reports of fetal deaths in women who became pregnant following an Essure implant.

[fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm, June 24, 2015]

The FDA announced in June that it will hold a meeting in September to discuss the risks of the birth control implant, such as unintended pregnancies, miscarriages and perforation of the uterus and fallopian tubes. The FDA has scheduled the meeting for September 24 so its Obstetrics and Gynecology Devices Panel can discuss data regarding Essure's safety and effectiveness. The federal regulatory agency said that it was soliciting feedback from its panel members, presenters and the public to help the agency form "recommendations and next steps about Essure."

[fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm, June 24, 2015]

About Southern Med Law
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
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Cell: 205-515-6166
Fax: 205-547-5526
francois@southernmedlaw.com
http://www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam

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