Essure Birth Control Lawsuit

woman at doctor's office 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.

Fill out our Free Case Review form or give us a call at (717) 888-8888 to get started.

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
Hysterectomy
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:

November 2013

The FDA requires Bayer to update Essure’s warning label to include risks of chronic pain and device migration.

September 2015

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.

February 2016

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.

November 2016

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.

April 2018

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.

July 2018

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.

Complete a Free Case Review form now.

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.

Call (717) 888-8888 or fill out our Free Case Review form today.

Free Case Review

No Upfront Fees

Recent Results

$10,043,952.13 Personal Injury
Schmidt Kramer, P.C.partner Gerard C. Kramer won a personal injury action for $10,043,952.13 in Northumberland County on behalf of a volunteer firefighter who was the victim of Intentional Tort. The 50-year-old volunteer firefighter was seriously injured when a barn collapsed, causing a spinal injury which left him a paraplegic. The claim was brought against the arsonist who intentionally started the fire. It is believed that the verdict is the highest ever in Northumberland County.
View Results
$4,034,000.00 Personal Injury
Yesterday a Judge in Union County (Lewisburg, PA) awarded a couple from New Berlin, Pennsylvania, over $4,000,000 because the husband was shot while turkey hunting.You might ask yourself, how does a turkey hunting accident end up with that type of verdict? In order to understand the verdict you would have to know our clients. They are good people who had their life wrecked. Plus, you would have to know the defendant, who should not have been hunting with a gun because he was prohibited after a previous criminal conviction.It is a good verdict, because the Judge was able to do two things with his decision. First, he communicated to two very good people that their losses were something that those of us on the outside could appreciate and value. Mike Hobbins (our client) is a 51 year old guy who lost his sight because a convicted felon --who should not have even possessed a gun-- went hunting illegally, and broke with impunity the most fundamental rule in hunting: identify your target before you pull the trigger. The Judge accepted the financial loss Mr. Hobbins' suffered, but listened closely to the evidence of less tangible losses. When Mike broke down on the stand, because his daughter would end up walking him down the aisle at her wedding, as opposed to how it was supposed to go, the Judge was listening. When Mike could not keep it together, because of how emasculating it was for him not to be able to provide financially for his family, the Judge was listening. It was facts like these that the Judge cited to support the $2,000,000 award for non-economic damages. Second, the Judge wanted to send a message. Union County is a hunting county. Many of the residents hunt there, and people from outside the area come to Union County to hunt. It was my impression, from the Judge's statements as he rendered his decision, that he wanted to send a message to the people in Union County to protect them in their sport. The rules in place to restrict people convicted of crimes not to have a gun are not to be broken. Hunting is serious and you have to identify your target before you shoot. When you turn your back on the rules that are set to provide safety in a sport, you risk being an example. Here, the $1,000,000 punitive damage award sends that message loud and clear.When it really comes down to brass tacks, the right action was taken against a Defendant who may never truly appreciate what kind of impact his reckless choices caused.At Schmidt Kramer, we are injury lawyers. That means we work with people who were hurt in car accidents, who were hurt by the neglect of nursing homes, or those that were seriously injured because of the reckless, thoughtless acts of others. If you or a loved one have been injured in Pennsylvania, we may be able to help. While the verdict yesterday is not one that is representative of every case we do, it does show that serious and dedicated representation can bring good results.Joe ChapmanJanuary 18, 2013
View Results
$2,200,000.00 Auto Accidents
On Monday, January 6, 2014, Schmidt Kramer accident lawyer Scott Cooper obtained a verdict on behalf of his client who is the widow of a man who died in a fiery crash on Interstate 78 in Lebanon County. The awarded verdict of $2.2 million was in a nonjury proceeding before a federal judge in the Middle District of Pennsylvania. That verdict includes $100,000 in punitive damages assessed against the owner of the trucking company.Kamilah Claxton won summary judgment in November after the defendants, Sukhwinder Singh and the trucking company for which he worked, failed to file a brief in opposition to Claxton's motion, which was made in September. The verdict in Claxton v. Singh was issued after the court held a non-jury assessment of damages earlier this month."Mr. Sukhchan Singh, the employer, is liable on the basis of respondent superior, but was also grossly negligent in failing to maintain his vehicle in compliance with state and federal law, particularly with regard to having required safety inspections and correcting defects in its braking equipment," said U.S. District Judge William W. Caldwell of the Middle District of Pennsylvania in his opinion accompanying the verdict."He was also grossly negligent in entrusting his vehicle to Sukhwinder Singh, an inexperienced truck driver who had failed the written test and driving test multiple times before finally earning his commercial driving license," Caldwell said.
View Results
$1,200,000.00 Personal Injury
A Dauphin County jury has awarded a $1.2 million verdict to the parents of a 5-year-old who had an anoxic brain injury and stopped breathing after he had a tonsillectomy.2012-06-26 10:00:00 AMDate of Verdict: June 19. 2012Court and Case No.: C.P. Dauphin County No. 2009-CV-14003-MMJudge: Scott EvansType of Action: Medical malpracticeInjuries: Anoxic brain injuryPlaintiffs Counsel: Terry S. Hyman, Schmidt Kramer, HarrisburgPlaintiffs Experts: Dr. Anna H. Messner, liability; Lucille Packer, Pediatric Otolaryngology, Palo Alto, Calif.; Terry P. Leslie, vocations and earning capacity, Lancaster; Dr. Hilary B. Berlin, pediatric psychiatry, Great Neck, N.Y.Defense Counsel: Andrew H. Foulkrod, Darlene K. King, Foulkrod Ellis, Camp Hill, PADefense Experts: James C. Reilly, Pediatric Otolaryngology, Wilmington, DEComment: A Dauphin County jury has awarded a $1.2 million verdict to the parents of a 5-year-old who had an anoxic brain injury and stopped breathing after he had a tonsillectomy.The entire verdict came against Dr. Andrew M. Shapiro, the doctor who plaintiffs Reginald Graham and Tykeisha Metz alleged chose to have the boy monitored at a pediatric ward. The plaintiffs argued Shapiro failed to tell nurses caring for the baby about, and how to care for, the boy's enhanced risk for respiratory failure.The jury came back on June 19 and awarded Reginald Graham and Tykeisha Mets $500,000 in non-economic damages and $686,170 in loss of future earning capacity, according to the plaintiffs counsel.According to the statement, the baby's mother brought him to Shapiro because she was "'afraid that he might stop breathing during his sleep,'" the plaintiffs' pretrial statement said. Shapiro performed a sleep study and observed the baby's Apnea Hypopnea Index to be 43 — four times higher than what's considered severe. A tonsillectomy and adenoidectomy were performed.According to the plaintiffs, the baby's sleep study results put him at an increased risk for post-operative respiratory complications. Despite this, they argued in the statement, Shapiro ordered the pediatric nurses at the Harrisburg Hospital general pediatric ward to observe the boy as they would any other patients — about once every four hours.The pretrial statement said that one in four children who have an AHI in the 40s and oxygen desaturation below 80 have some type of respiratory problem. The younger the child, the greater the risk of a respiratory problem, the statement said.According to the statement, Shapiro took off the child's pulse oximeter, the finger-mounted device used to measure blood oxygen, and ordered a heart and respiratory rate monitor. The child was 11 months old at the time.The plaintiffs pled that the baby was last seen at 4 a.m. There was no record of his oxygen saturation for the next hour and 45 minutes. He stopped breathing a 6:40 a.m., and his brain was without oxygen long enough to cause demonstrable injury on an MRI."Immediately prior to his surgery, [the child] was a normal child, who could say mama, eat finger foods, and was just on the verge of walking," the statement said. "After his code, [he] was like a newborn. He could not lift his head or sit up. He could not talk. He could not move."In his pretrial statement, Shapiro argued that he recognized the child's pre-operative sleep study showed he was driven to breath by decreased blood oxygen saturation, which he said was typical in patients with obstructive sleep apnea.He argued the American Academy of Otolaryngology dictates that admission to the intensive care unit is not the standard of care. In the statement, he said nurses did not observe signs of respiratory distress. No alarms sounded until the child arrested, the statement said.He said the baby likely arrested as a result of hypoglycemia and/or an acute aspiration, which he argued would not have been identified by blood oxygen saturation.— Ben Present, of the Law Weekly
View Results
$1,024,040.80 Auto Accidents
Scott Cooper settled a wrongful death case on behalf of the widow of a police office who was killed in a car accident in the line of duty for $1,024,040.80. The claim against the other driver was amicably resolved before suit was filed for the entire available policy limits for the other driver. The case took place in Adams County, PA.
View Results

Testimonials

Dear Scott,
Hello there! I’m a little late to the game here, but I wanted to be certain I wrote to you. Oops—sorry for the typo! As you’ve probably gathered, I am writing you from a typewriter. Do you still use these in the office? Back on topic, I wanted to take a moment to express my deep gratitude for your guidance and support throughout the entire legal process for my accident. Can you believe it’s been five years?? Your attention to detail, professionalism, and delicate handling of my case made an incredibly difficult time more manageable for me and my family. We’re forever grateful.
From the moment you stepped foot in that hospital room with me, I felt relieved to have someone in my corner like you and your team. You took the time not only to explain each legal step in a way that made sense but also to acknowledge the emotional weight of what I was going through. That delicate balance—handling the intricacies of my case with precision while also being sensitive to my well-being—is something I will always be grateful for. In many ways, the outcome of the case reflected your dedication, but what has stayed with me even more is how you treated me throughout the process—with patience, respect, and compassion. You listened to my concerns and reassured me in moments of uncertainty. And even now, I feel your compassion each year on my birthday when I receive a text from you!
Thank you, not just for the outcome, but for the way you handled each moment. You are an incredible lawyer, but more importantly, an incredible person, and I was fortunate to have you in my corner.
With heartfelt gratitude,
Ricky D
Definitely were people of their word. Certainly helped me through my whole case
The legal team was very professional and met my needs I would highly recommend them
Monte cargile
Very great experience working with you guys continue the great service timely response communication well understand
jackie duffus
Schmidt Kramer is simply definition of hardworking, they are trustworthy and get best claim you could never think of.