Essure’s manufacturer Bayer has recently announced that it will be discontinuing the sale of Essure birth control devices in the United States by the end of 2018. This new action comes months after the U.S. Food and Drug Administration (FDA) issued an order restricting the sale and distribution of Essure devices back in April of 2018. This order required health providers and facilities to inform patients of the potential risks of Essure, including chronic pain, organ perforation and device migration.
Thousands of lawsuits have been filed against Essure, a permanent birth control solution and non-surgical procedure which consisted of inserting two metal coils into each fallopian tube. Women are claiming that Bayer failed to warn patients of the device’s severe complications and side effects. If you or someone you love has suffered permanent injury or illness after being implanted with the birth control device, you may be entitled to file an Essure lawsuit.
The qualified Pennsylvania defective product lawyers at Schmidt Kramer will review your claim and help you determine your legal rights. Your consultation is free and at no obligation to you.
Essure Complications and Side Effects
The Essure birth control device is made up of two small metal coils. When they are implanted they block the eggs from moving through the fallopian tubes, thus preventing pregnancy. After the procedure, it takes roughly three months for the body to form scar tissue around the inserts which creates a natural barrier or blockage without any surgical incision necessary.
Over the years, Bayer has insisted Essure’s safety and effectiveness and how such a minimally invasive procedure has helped rather than hurt patients. However, many women are coming forward after experiencing severe complications and side effects from implanting the Essure device.
The most severe Essure complications and side effects include:
- Chronic pelvic or abdominal pain
- Unintended or unwanted pregnancy
- Migraine headaches
- Fetal death
- Organ perforation
- Device breakage or migration
- Ectopic pregnancy
- Menstruation problems
- Allergic reactions
Removal of the device can require multiple surgeries if the device breaks or migrates into the pelvis or abdomen, which can cause significant damage to the uterus, fallopian tubes, colon or another organ.
Other common but less severe complications and side effects from Essure after implantation include bleeding, cramping, itching, rashes, fatigue, weight fluctuation and hair loss.
If you have experienced severe injury or illness after the implanting of an Essure device, you may be able to obtain compensation for medical bills, lost wages, and pain and suffering.
Schedule a free, no-obligation case evaluation today by calling (717) 888-8888.
Timeline of FDA Actions on Essure
Back in 2002, the FDA originally approved Essure as a Class III medical device and received the agency’s most strict review prior to coming on the market. Essure was originally manufactured and distributed by Conceptus Inc., an American medical products manufacturer, and then acquired by the German pharmaceutical company Bayer in mid-2013.
Since its approval, the FDA has required Bayer to submit regular reports related to Essure’s safety and effectiveness, including any reports of adverse effects. Instead of adhering to the requirements given, Bayer has had a troubled history with the FDA. The company has been cited multiple times over the years for violating those conditions.
Below is a timeline of the FDA’s history with Essure and its manufacturer Bayer:
The FDA requires Bayer to update Essure’s warning label to include risks of chronic pain and device migration.
The FDA holds a public hearing with government officials regarding the side effects of Essure. By this point, there are thousands of reports of patients being harmed by these devices.
The FDA orders Bayer to conduct a new clinical trial of the Essure device to explore the potential risks for women and examine how it is being used in clinical practice.
The FDA requires Bayer to add a black box warning on the product package. It is the strongest warning issued by the FDA notifying patients and health care providers about the serious side effects and complications caused by the Essure birth control device. This includes the risks of pelvic or abdominal pain, allergy, perforation and more.
The FDA orders the restriction of sales and distribution of Essure to health care providers and facilities. The order requires doctors to inform patients of complications and side effects associated with the Essure device before implantation.
Just a few months after the FDA threatened civil and criminal penalties over non-compliance with new restrictions, the company announces that it will discontinue all sales of Essure birth control devices in the U.S. by December 31, 2018.
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Essure Verdicts and Settlements
Thousands of Essure lawsuits have been filed against Bayer over serious side effects. These lawsuits make various allegations against the company, including:
- Failure to comply with federal safety laws
- Failure to guarantee doctors who recommended this product were competent to do so
- Failure to provide proper warnings even when knowing about the side effects
- Failure to properly train doctors about safe use of this product
Some outlets have reported that Bayer has lost $413 million in the last several years because of the legal problems associated with Essure.
If you were implanted with an Essure birth control device and suffered serious side effects like chronic pain, perforated organs, device migration, ectopic pregnancy, or another permanent injury or illness, you may be able to file a lawsuit.
Contact Schmidt Kramer today at (717) 888-8888 to discuss your legal options.
Consult Our Defective Product Lawyers
If you have suffered from severe side effects from an Essure implant, you may be entitled to file a lawsuit and obtain compensation. When a company such as Bayer fails to provide consumers with a safe product, they should be held accountable for their negligent actions.
Contact a defective product attorney in Pennsylvania who is here to help victims who have been significantly impacted by this dangerous and defective medical device. Learn more about your legal rights with a risk-free, no obligation consultation to review your claim and determine if you are owed compensation for the damages you have suffered.
At Schmidt Kramer, we work on a contingency which means there are no costs or fees unless we help you recover the compensation you deserve.