Essure Side Effects Lawsuit | Essure Birth Control Lawsuit
Essure Birth Control Lawsuits Filed After Birth Control Implant Was Purportedly Found To Cause Dangerous Side-Effects Such As Sterilization and Organ Perforation | essure lawsuit 2015, essure lawsuit commercial, essure lawsuit class action, lawsuits against essure, essure class action lawsuit
***Essure News: FDA To Hold Meeting On Essure Complaints Thursday 9-24-15
Essure Side Effects Lawsuit info: Thousands of women may have been injured by Essure, a birth control implant manufactured and marketed by Bayer Healthcare Pharmaceuticals. The device, which is intended to render the recipient permanently sterile, is currently the subject of citizen petition urging the U.S. Food & Drug Administration (FDA) to order an Essure recall. Among other things, the petition charges that Conceptus, Inc., which launched Essure 13 years ago, perpetrated fraud during its clinical trials.
Southern Med Law is now offering free, no-obligation Essure side effects lawsuit case reviews to alleged victims of serious Essure side effect injuries, including:
- Extreme pelvic pain and cramping
- Severe back pain
- Severe, unexplainable fatigue
- Depression and suicidal thoughts
- Weight gain and weight fluctuations
- Heavy bleeding
- Menstrual irregularities
- Device migration
- Organ perforation
- Device breakage
- Adverse reactions due to nickel allergy
As both an attorney and practicing obstetrician/ gynecologist, Dr. François Blaudeau possesses a unique understanding of the medical and legal issues at the center of the Essure controversy. If you or a woman you love experienced painful and debilitating complications following implantation of this device, please call Dr. Blaudeau to learn more about your legal rights today.
Essure Side Effects Lawsuit Information News
What is Essure?
Ensure consists of a four-centimeter, micro-insert comprised of an expanding coil made of a stainless steel inner coil, a nickel Titanium (nitinol) expanding outer coil and polyethylene (PET) fibers. The micro-inserts are placed directly into the fallopian tubes, where the coils expand upon release. Due to inflammation brought on by the PET fibers, scar tissue ultimately obstructs the tubes, permanently preventing fertilization. Conceptus introduced Essure in 2002. At the time, the implant was considered a breakthrough because it offered women an alternative to surgical sterilization. In 2013, Conceptus was acquired by Bayer.
Essure Side Effects and Complications
In May 2015, The New York Times reported that the FDA had received more than 4,000 side effects or 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. Pain and other serious complications also emerged early in clinical trials. In one study, 200 out of 269 women were implanted with the device. But in nine cases, a coil perforated the fallopian tube, was expelled, or lodged elsewhere in the body. Nearly one in 10 participants later reported painful intercourse, while one in eight had painful menstrual periods during the first three months.
In another trial involving 558 women, there were 21 instances where a coil perforated the fallopian tubes, was expelled, or ended up in the wrong place in the body. At least eight women had surgery to be sterilized or to remove a misplaced coil, according to The New York Times. Other participants in the study reported abdominal and back pain, as well as painful intercourse.
Because the FDA was concerned that these two trials only followed women for a couple of years at most, the agency approved Essure on the condition that the women who participated in the trials be monitored for four more years. But according to the Times, only 171 women in the smaller trial were followed for five years. Of those, five women had hysterectomies and at least one became pregnant. Participants reported 270 adverse events, including dozens involving pain and heavy menstrual periods.
Only 366 (70%) of those included in the larger trial were followed for five years. Fifteen had hysterectomies, while 38 percent experienced unusually heavy periods on a recurring basis. One in 20 patients had recurrent pelvic pain, one in 15 had recurrent painful periods, and nearly one in 25 had recurring pain with intercourse, the Times said.
FDA Essure Investigation Into Essure Side Effects
In 2015, the FDA launched an investigation in response to the Essure recall petition. The petition had asserted 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.
Because Essure was brought to market via 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). If the Court rules that the conditional approval for Essure is no longer valid, many other women who were allegedly injured by this contraceptive device may be able to file an Essure side effects lawsuit to obtain compensation for their injuries.
Legal Help for Victims of Essure Side Effects and Complications and filing a Essure side effects 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.