Essure Lawsuit | Essure Lawsuits Involving Hysterectomy
Essure Lawsuits Filed After Bayer’s Birth Control Device Migrated And Required Surgery, Including A Hysterectomy, To Remove the Device.
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Women who have experienced complications from their Essure birth control system are now undergoing hysterectomies to remove the device, according to Essure lawsuit claims in mounting litigation against Bayer. Some Essure lawsuit plaintiffs say in their complaints that they decided to have the surgery because the Essure device migrated or broke and caused complications that required hospitalization. In one of the first federally filed Essure lawsuit complaints against Bayer, a Florida plaintiff said her birth control device migrated and landed behind her colon. According to the Essure lawsuit complaint, the plaintiff had a hysterectomy as well as other surgeries to remove Essure.
(Case No. 2:15-cv-00384, U.S. District Court, Eastern District of Pennsylvania)
Southern Med Law is offering free, no-obligation Essure lawsuit case reviews to victims who allege that Bayer’s birth control device required them to undergo a hysterectomy or other surgeries to remove the device. The Firm is also reviewing cases involving serious Essure side-effects. You can arrange for a free, no obligation Essure side effects lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.
Essure side-effect injuries include:
- Organ perforation
- Allergic reaction
- Excessive bleeding
- Chronic pelvic or back pain
Southern Med Law is currently representing women in Essure lawsuits who have suffered complications from the Essure birth control device. The firm’s founder, Dr. François Blaudeau, is an attorney and a practicing obstetrician/ gynecologist, who possesses a unique understanding of the medical and legal issues at the center of the Essure controversy.
Essure Birth Control Device
Essure is a permanent birth control system which was originally manufactured by Conceptus Inc. when it received approval by the U.S. Food and Drug Administration (FDA) in 2002. Bayer bought Conceptus Inc. in 2013 and began marketing Essure. About 750,000 women and their doctors have chosen Essure, which is 99 percent effective at permanently preventing pregnancy, according to Bayer. Essure is a flexible device with coils that are inserted into each fallopian tube. In three months, a scar-tissue barrier forms around the inserts that prevents contraception.
Essure Citizens Petition alleges that advertisements for Essure’s prevention of pregnancy were misleading
In February 2015, a Citizen’s Petition signed by more than 2,100 women, was filed with the FDA claiming fraud in the premarket approval process which included altering medical records of trial participants. The petition also alleged that advertisements for Essure’s prevention of pregnancy were misleading because there were four pregnancies during the clinical trials and five pregnancies during the first year of commercial experience and this information was concealed from patients. The petition asked the FDA to revoke Essure’s premarket approval and require Bayer to initiate an Essure recall “due to gross consumer deception.”
[regulations.gov/document?D=FDA-2015-P-0569-0001, FDA, February 20, 2015]
[abc15.com/news/local-news/investigations/fda-responds-to-petition-to-recall-essure-permanent-birth-control-agency-will-investigate, ABC15, April 1, 2015]
FDA has received 5,093 adverse event reports over Essure from the time the device was approved
The FDA said that the agency had received 5,093 adverse event reports over Essure from the time the device was approved in November 2002 to May 31, 2015. As complaints over Essure continued, the FDA held a public hearing in September 2015 concerning the safety and efficacy of the medical device. Speakers included women who experienced ectopic pregnancy, unintended pregnancy,unusual bleeding, abdominal and pelvic pain, hallucinations, and other complications after having an Essure implant. The FDA’s Obstetrics and Gynecology Devices Advisory Panel suggested restricted use of the Essure birth control system. In February, the FDA required Bayer to place a black box warning on Essure’s label and ordered the company to conduct new studies that assess Essure’s risk in different groups of women.
[nytimes.com/2015/09/25/health/fda-panel-discusses-essure-contraceptive-implant.html?_r=0, September 24, 2015]
[fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm488313.htm, FDA, February 29, 2016]
Court documents show that Essure lawsuits have been filed alleging that Bayer failed to adequately warn the public about the complications. Bayer has unsuccessfully sought to have the cases dismissed, contending in court papers that the company is shielded from liability from the Essure lawsuits. In July, Essure lawsuit plaintiffs involved in Essure lawsuit complaints asked the U.S. Judicial Panel on Multidistrict Litigation to consolidate all federally filed Essure lawsuits for coordinated pretrial proceedings.
(Essure lawsuit – In Re: Essure Permanent Birth Control Litigation, Case No. 2:14-cv-07315)
About Southern Med Law And Filing An Essure Lawsuit
Throughout his career, Dr. Blaudeau has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made Southern Med Law an aggressive and effective advocate for those who were harmed due to negligent medical device manufacturers. If you or a loved one were injured by Essure side effects, please contact Southern Med Law today to learn more about your legal rights. You can arrange for a free, no obligation Essure side effects lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.