FDA To Investigate Complaints of Essure Side Effects Purportedly Associated With Birth Control Implant


FDA Reviewing Complaints of Essure Side-Effects After Thousands of Women Sign Citizens Petition Seeking Essure Birth Control Recall

Essure-Problems-Southern-Med-LawThe Food and Drug Association (FDA) has recently announced it will look into complaints of Essure side effects and injuries after the filing of a citizen’s petition with the FDA that seeks an Essure recall on behalf of thousands of women allegedly injured by the device. Complaints surrounding the Essure is a birth control implant, which is marketed by Bayer Healthcare Pharmaceuticals, state the coils have pierced the fallopian tubes and lodged in other organs as well as causing severe back and pelvic pain and prolonged heavy menstrual periods. Dr. Blaudeau of Southern Med Law is both an attorney and practicing gynecologist, and will be monitoring the FDA’s findings for Essure birth control in the best interest of his clients.
[abc15.com/news/local-news/investigations/fda-responds-to-petition-to-recall-essure-permanent-birth-control-agency-will-investigate, ABC 15.com, April 1, 2015]

According to a report recently published by The New York Times, the Essure implant was approved by the FDA 13 years ago, and was considered a breakthrough because it offered women an alternative to surgical sterilization. Consisting of a small metal and polyester coil, Essure is placed into a woman’s fallopian tubes in order to make her permanently sterile. The device was originally marketed by Conceptus, Inc. which was acquired by Bayer in 2013.
(nytimes.com/2015/05/04/us/long-term-data-on-complications-adds-to-criticism-of-contraceptive-implant.html, New York Times, May 4, 2015)

The FDA is currently reviewing a citizen petition signed by thousands of women who are seeking an Essure recall. The petition asserts that Conceptus perpetrated fraud during Essure clinical trials, violated the terms of the FDA’s premarket approval of the device and violated several federal laws in the manufacturing and marketing of the implant. According to the Times, the FDA has received more than 4,000 complication reports involving Essure, including reports of severe back and pelvic pain, heavy prolonged menstrual periods, and coils that pierced the fallopian tubes and lodged in other organs.
(abc15.com/news/local-news/investigations/fda-responds-to-petition-to-recall-essure-permanent-birth-control-agency-will-investigate, ABC 15.com, April 1, 2015)
(nytimes.com/2015/05/04/us/long-term-data-on-complications-adds-to-criticism-of-contraceptive-implant.html, New York Times, May 4, 2015)

Because Essure went through the FDA’s premarket approval process, Bayer is currently shielded from product liability lawsuits involving the implant. However, court documents indicate that an Essure lawsuit currently pending in the U.S. District Court, Eastern District of Pennsylvania, seeks to remove that protection. (Case No. 2:2015cv00384)

“As this lawsuit points out, the FDA conditionally approved Essure in accordance with a specified list of conditions, including a stipulation that the implant’s manufacturer inform the FDA whenever it receives information that reasonably suggests that the device may have caused or contributed to a serious injury,” says Dr. François Blaudeau, the founder of Southern Med Law. “The complaint alleges that Bayer concealed adverse event information related to Essure, thereby invalidating its conditional approval. If this challenge is successful, it will pave the way for thousands of women allegedly injured by the implant to file their own Essure lawsuits against Bayer.”

As both an attorney and practicing gynecologist, Dr. Blaudeau possesses a unique understanding of the medical and legal questions relating to Essure. 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.

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

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