Essure Trials Show Pain, Perforated Organs And Other Complications From Birth Control Device

   

Essure Lawsuit Alleges That Bayer Should Not Be Protected Against Litigation Regarding The Permanent Birth Control Device Due To The Alleged Serious Injuries Associated With The Contraceptive.

Essure-Problems-Southern-Med-LawSouthern Med Law reports that early trial studies on Essure birth control show that women experienced pain, heavy menstrual periods and at least one pregnancy after having the permanent birth control device implanted. The law firm cites an essure report submitted to the U.S. Food and Drug Administration (FDA) in 2006 that found five patients in a clinical study underwent a hysterectomy after an Essure implant, and one patient became pregnant. A study in the Human Reproduction Journal published in 2003 found nine of the 200 study subjects reported Essure’s coil perforated their fallopian tubes or the device was expelled and moved to another part of the body. The New York cited a study published on April 24, 2015 in The Journal of Minimally Invasive Gynecology that followed up 518 original Essure study participants for five full years. Of those participants, 15 women had hysterectomies, 38 percent reported unusually heavy menstrual periods on a regular basis, 1 in 20 patients had recurring pelvic pain and nearly 1 in 25 patients had recurring pain during sexual intercourse, according to the New York Times report.
[humrep.oxfordjournals.org/content/18/6/1223.full.pdf, 2003]
[mobile.nytimes.com/2015/05/04/us/long-term-data-on-complications-adds-to-criticism-of-contraceptive-implant.html?_r=4&referrer, May 4, 2015]

“These health complications allegedly stemming from the Essure contraceptive device are similar, if not identical to the complaints in the citizen’s petition that is now under review by the FDA,” said Dr. François Blaudeau, founder of Southern Med Law, which represents women who have suffered serious health complications from medical devices such as Essure.

The law firm has a unique understanding of the medical and legal questions associated with Essure because Dr. Blaudeau, is a practicing obstetrician/ gynecologist and an attorney. If you or a woman you love suffered complications allegedly related to Essure, contact Southern Med Law as soon as possible 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.

According to the New York Times, a citizen’s petition was submitted to the FDA signed by thousands of women asking for a recall of Essure. The petition contends that Conceptus, Essure’s original marketer which was acquired by Bayer Healthcare Pharmaceuticals in 2013, perpetrated fraud during Essure’s clinical trials. The petition also contends that Conceptus violated the FDA’s terms of premarket approval of the device and violated several federal laws in manufacturing and marketing Essure. The FDA has received more than 4,000 complication reports regarding Essure, such as severe back and pelvic pain, heavy prolonged menstrual periods and the contraceptive’s coils perforating fallopian tubes and lodging in other organs, according to the New York Times.
[mobile.nytimes.com/2015/05/04/us/long-term-data-on-complications-adds-to-criticism-of-contraceptive-implant.html?_r=4&referrer, May 4, 2015]

The firm notes that Essure is a permanent birth control device that received FDA approval in November 2002. According to the FDA, Essure involves placing soft, flexible inserts into the fallopian tubes. After about three months, tissue forms around the inserts. Conception is prevented when the build-up of tissue creates a barrier that keeps sperm from reaching the eggs, according to the FDA. Since the medical device’s approval, the agency said the most frequent adverse events reported were pain hemorrhage, menstrual irregularities, fatigue, and weight fluctuations. The most frequent problem reported about the device was the migration or moving of the device, according to the FDA.
[www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/ucm371014.htm, May 18, 2015]

Court documents indicate that an Essure complaint has been filed seeking to remove Bayer from under its shield from product liability lawsuits. According to the complaint, the FDA conditionally approved Essure with a specific list of conditions, including a stipulation that the implant’s manufacturer inform the FDA whenever it receives information that reasonably suggests that Essure may have caused or contributed to a serious injury. The complaint alleges that Bayer concealed adverse event information related to Essure, thereby invalidating its conditional approval. (Case No. 2:2015cv00384, U.S. District Court, Eastern District of Pennsylvania)

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
Southern Institute for Medical and Legal Affairs
2224 1st Ave., North
Birmingham, AL 35203
Phone: (205) 547-5525
Fax: (205) 547-5526
francois@southernmedlaw.com

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