The fda required bayer to add a black box warning to the labeling information to let patients know about reports of organ perforation coils moving to the abdominal or pelvic cavity.
Essure side effects lawsuit.
It warns that some side effects are serious and may require surgery.
For all the advantages of the procedure and how easy it is to perform tens of thousands of women have paid a big price for going through with essure.
6000 lawsuits filed till nowconceptus inc a subsidiary of bayer ag developed essure which is a class iii device for permanent surgical sterilization in women.
They can be short term or long term.
Women have complained of side effects like chronic pain menstrual irregularities and device migration on support websites like essure problems as well as in formal complaints to the fda.
Essure based procedure for surgical sterilization in women is reported to have many problems and side effects.
Thousands of lawsuits filed against bayer essure s manufacturer allege that the company was aware of essure s high risk for complications but failed.
In september 2020 the company reported approximately 39 000 women had filed essure lawsuits.
The fda placed a black box warning on essure in november 2016.
However due to the serious nature of side effects linked to essure the lawyers at schmidt clark llp are investigating potential lawsuits against bayer healthcare the company that makes essure.
For many women it appears the positive aspects of essure disappear the moment they leave the doctor s office.
Severe side effects led some women to file essure lawsuits against the device s maker bayer.
Amidst the media coverage and heavy fda oversight thousands of women linked their side effects to essure.
They can be short term or long term.
Common side effects medical conditions and complaints from the women injured by the essure device include.
Essure was approved by the food and drug administration fda on november 4 2002.
The bulk of the lawsuits filed in the wake of revelations regarding essure seek restitution for harm done based on the allegation that the company did not fully disclose the potentially severe side effects of the device.
Learn more about essure s brushes with the fda here.
Abdominal pain extreme abdominal bloating stomach pain irregular menstrual bleeding heavy menstrual bleeding nickel allergies fatigue depression headaches migraines weight changes loss of teeth loss of hair internal organ perforation device migration and many more.
The lawsuits against essure.
After being implanted a barrier of scar tissue forms around the device which blocks sperm from reaching the eggs.
Bayer denies wrongdoing women implanted with essure have reported for many years serious side effects from allergic reactions and chronic pelvic pain to the need for a hysterectomy and even death.