FDA Study Links Essure Birth Control to Higher Rates of Pain, Bleeding

New data from a study ordered by the U.S. Food and Drug Administration (FDA) suggest that women with the Essure permanent birth control implant face higher rates of pain and bleeding compared to women without the device.

The new findings come from a recently published postmarket surveillance study into the long-term safety of Bayer’s Essure birth control device, which was taken off the U.S. market in December 2018 after thousands of women reported adverse side effects and serious complications.

An FDA press release from July 8, 2020 details the agency’s efforts to better understand complications women with Essure may experience. According to early overall results, researchers found Essure patients, when compared to women who underwent tubal ligation as their permanent birth control, tend to have higher rates of:

The FDA reported that it will work with Bayer to release an additional analysis at the 1-year mark following a patient’s Essure implantation, which is earlier than the previously planned 3-year analysis.

The agency continues recommend that women using Essure successfully to prevent pregnancy can and should continue to do so, and that women who suspect the device may be causing pain, bleeding, or other related symptoms speak with their doctors, as device removal can pose risks.

Essure Birth Control: A History of Safety Concerns

Since its approval in 2002, Bayer’s Essure permanent birth control has been the subject of numerous complaints from women across the country, many of whom have reported adverse side effects after having the device implanted, as well as the need for risky removal procedures.

Some of the most serious side effects associated with Essure include:

Over the past several years, health agencies and watchdogs have taken a number of actions to monitor the safety of Essure and inform women with the device about potential risks. In February, researchers at the National Center for Biotechnology Information (NCBI) suggested that Essure be removed in all symptomatic women. Previous studies have also showed that women with Essure face increased risks of repeat procedures, and that women who undergo Essure removal procedures face numerous risks, potential complications, and physical, financial, and emotional repercussions.

BCH: Fighting For Victims of Medical Device Injuries

Bailey Cowan Heckaman PLLC has been closely following safety concerns, studies, and FDA oversight of Essure for several years, and has made our team available to women and families who’ve suffered losses as a result of the implant in their fight for justice and compensation.

As a firm nationally recognized for our work in complex and high-profile claims – including those involving defective drugs and medical devices – BCH is here to help anyone who would like to learn more about their rights and legal options after experiencing side effects and complications involving Essure.

To request a FREE evaluation of your case, call us or contact us online. Based in Houston, BCH proudly serves victims and families nationwide.

Study: Essure Birth Control Device Should Be Removed in All Symptomatic Women

A study recently published by the National Center for Biotechnology Information (NCBI) suggests that the implantable birth control device Essure “should be removed in all symptomatic women.”

According to patient reports, most adverse health effects – including perforations, expulsion, and infection – associated with the Essure device have been attributed to incidents during and immediately after implantation. Researchers in this study, however, focused on analyzing the prevalence and severity of non-gynecological symptoms before and after Essure implants were removed.

Non-gynecological symptoms associated with Essure include:

As part of the study, women who experienced at least four non-gynecological symptoms associated with Essure completed a questionnaire prior to device removal, as well as 1, 3, and 6 months after removal. Patients with bleeding or tube perforation were excluded from the study.

Patients in the study experienced their first clinical symptoms at anywhere from 1-60 months (median 13 months) post-placement, and had their devices removed within 12-72 months (a median of 38 months).The most prevalent symptoms prior to device removal ranged from urinary tract disorders (26%) to weakness (96%).

In terms of symptom severity (on a scale of 0 to 10) researchers found the following:

Ultimately, researchers observed a substantial decrease in symptom severity when Essure devices were removed – leading them to conclude that all women with Essure devices who experience symptoms should have them removed.

BCH: Helping Essure Victims Nationwide

The study is yet another affirmation of the dangers associated with Essure, a permanent, implantable birth control system that’s been used by over 750,000 women as a means to prevent pregnancy. In the years following its 2002 FDA approval, Essure – which was developed by Conceptus, a company later bought by Bayer, became the target of thousands of lawsuits filed by women and families who claim the medical device caused severe and fatal injuries.

What followed was a timeline of Essure’s ultimate downfall:

Essure may no longer be sold, but its impact is still felt by thousands of women who must endure painful symptoms, serious injuries, and fatal risks. At Bailey Cowan Heckaman PLLC, our award-winning attorneys are actively representing women nationwide in Essure litigation. If you have a potential case, contact us for a free consultation.

Confidential Papers Brought to Light by Superior Court Judge in Essure Mass Tort

Bayer is in the middle of a mass tort filed against it for dangers caused by its Essure birth control system. Some of the worst complaints from women who used the birth control system include patient and infant deaths, internal organ perforation, autoimmune diseases, and chronic pelvic pain.

Much of the discovery documents in the Essure mass tort have been kept confidential, making it difficult for plaintiffs and their attorneys to construct solid cases. In the interest in public health and safety, though, Alameda County Superior Court Judge Winifred Smith recently announced she would order for key documents to be declassified.

There have been millions of pages’ worth of information and evidence brought forth during discovery due to the sheer size of the mass tort. Smith’s order would only uncover 16 discovery dockets and a small portion of the deposition. The uncovered documents are said to focus on how Bayer responded to Food and Drug Administration (FDA) inspections and investigations into the reported dangers of Essure.

Judge Smith also explained that many of the documents she wants to declassify are more than 10 years old. This is important because trade secret laws generally limited the confidentiality of such documents to just 10 years. Counsel representing Bayer had been arguing that allowing the public to see the documents could constitute a trade secret violation.

(You can view a full article about this recent development in the Essure mass tort by clicking here and visiting Law.com. Login and subscription may be required.)

What the Essure Document Development Means to You

Have you been injured – or did you lose a loved one – due to a defect with Bayer’s Essure birth control device? Now that crucial internal documents from Bayer and the FDA are likely to be unlocked and declassified, there has never been a better time to stand up to Bayer and fight for justice. At Bailey Cowan Heckaman PLLC, our national trial lawyers have helped thousands of Essure plaintiffs understand their rights and file against the medical device manufacturer. You can, too.

The Essure mass tort is still ongoing. You can join the mass tort by filing a claim yourself, using the legal guidance of our attorneys. Do not wait too long, though, as the window to file will close eventually.

Call now to speak with an Essure mass tort lawyer from Bailey Cowan Heckaman PLLC. Remember: We help clients nationwide!

Women With Essure Birth Control Device Face Increased Risks of Repeat Procedures, New Study Shows

As of 2019, following years of patient complaints and thousands of lawsuits filed by women who suffered serious and painful injuries, Bayer no longer sells its Essure Permanent Birth Control System. A non-reversible, non-surgical contraceptive device that had been heavily marketed as an alternative to procedures like tubal ligation (or “tying tubes”).

Essure has been associated with a number of serious and devastating adverse effects, including:

In addition to considerable pain and suffering, many women with Essure implants have had to undergo serious and costly medical procedures and surgeries to address their symptoms, repair devices, remove the devices entirely, or perform other needed treatment. According to new research, those types of revision procedures are far more likely to happen to women with Essure implants than women who use other forms of contraception/sterilization.

What Researchers Are Saying About Essure

According to a medical journal article recently published in Obstetrics & Gynecology, repeat procedure risks increase with the use of Essure birth control devices. The study comes from a team of physicians and researchers from the Department of Healthcare Policy and Research and NYC’s Weill Cornell Medical College. Here are some of their key findings:

Although some experts have commented that risks of repeat procedures may not impact all women who underwent hysteroscopic sterilization (the formal name for the Essure procedure), many of the hundreds of thousands of women with Essure devices already implanted have required such procedures and surgeries – and many more may as well in the following years. They also don’t deny that numerous women across the world have and still continue to suffer from a range of adverse effects and persistent pain associated with the device – which is why many have filed lawsuits against Bayer.

Justice for Victims of Essure-Related Injuries

On our blog, we frequently provide updates about news and events involving dangerous drugs and medical devices – including Essure. Recently, we’ve discussed how Essure concerns are still growing nationwide, and how the U.S. Food and Drug Administration (FDA) has pledged to better study Essure, its long-term effects, and improve the agency’s oversight of medical devices.

While those types of pledges are certainly welcomed, they’re made after numerous women have already suffered from the effects of Essure – from severe and chronic physical pain and emotional suffering to sizable medical expenses, lost income, and other economic and non-economic damages. As the FDA and Big Pharma have proven time and time again that they can’t or won’t effectively protect consumers, it often becomes the job of victims and plaintiffs’ attorneys to stand up, raise awareness, and seek justice that can produce needed changes.

In addition to prompting change, our personal injury lawyers at Bailey Cowan Heckaman PLLC are committed to helping women harmed by Essure as they seek financial compensation for the damages they incurred. Our civil trial lawyers have been recognized throughout the country for our work in pharmaceutical and medical device injury, product liability, and serious personal injury cases, and are prepared to help you better understand your rights, options, and how we can help you take the next steps in your legal journey.

Discuss a potential Essure case by contacting our firm. Bailey Cowan Heckaman PLLC offers free consultations, and proudly serves clients throughout the country.

FDA Commissioner Discusses Steps for Stronger Safety Oversight of Essure Birth Control Device After Removal from U.S. Market

On Thursday December 20, 2018, FDA Commissioner Scott Gottlieb, M.D., released a statement discussing the concerns surrounding Essure and the plans moving forward. Essure, a permanent birth control device linked to serious adverse effects in women, has also been the center of thousands of lawsuits filed by women worldwide.

With Bayer announcing it will no longer sell or distribute Essure in the U.S. come the end of the month, Gottlieb focuses his statement on providing updates about new steps the FDA is taking to revise and strengthen the post-market study of Essure. This includes the collection of long-term safety information after sales of Essure are discontinued, and better evaluation of the device’s safety profile when used in the real world.

As part of the post-market surveillance study’s revised protocol, the FDA and Bayer will adopt steps to strengthen the collection of evidence. These modifications include:

Gottlieb goes on to express the FDA’s commitment to continue it’s monitoring of the post-market study, and oversight of women who have the birth control device implanted. The agency has also announced advancements that will improve its monitoring systems and help regulators reach a new goal to be among the first agencies in the world that identifies and acts upon safety issues involving medical devices, such as its Medical Device Safety Action Plan, and the National Evaluation System of Health Technology.

Improving Medical Device Safety

Gottlieb’s statement and discussions of shake-ups and improvement plans within the FDA are welcomed, but the fact remains that federal regulators have considerable ground to cover when it comes to improving its oversight of dangerous and defective medical devices. In fact, many consumer advocates have expressed the need for the FDA to do more when it comes to preventing these types of events from happening in the first place. As Canadian health regulators recently announced, their plans to improve oversight of medical devices also include changes to the country’s pre-market approval process – somethings that’s desperately needed here in the U.S.

Additionally, while the statement does show the FDA is committed to studying long-term risks associated with Essure, it does little to help women stand up and protect their rights after they have already suffered harm and losses. That particular goal is one which victims and families will need to turn to the civil justice system and experienced civil trial lawyers to address.

Experiencing Adverse Effects Associated with Essure? Learn More About Your Rights.

At Bailey Cowan Heckaman PLLC, our nationally recognized attorneys are all too familiar with rectifying the failures of others, and holding them accountable for the preventable harm, pain, and suffering they cause. This is especially true when it comes to fighting back against the powerful corporations and pharmaceutical companies behind dangerous medical devices. We care about making a difference, and know that doing so requires decisive and determined action, not just promises and plans.

If you or someone you love has suffered adverse health consequences as a result of using Essure or any other dangerous medical device, pharmaceutical, or consumer product, our firm is here to explain your rights and options, and discuss how we may be able to help you pursue the justice and compensation to which you are entitled. Call or contact us online to speak with a member of our team. Bailey Cowan Heckaman PLLC serves clients nationwide.

Essure Birth Control Concerns Continue to Spread, Canadian Government Moves to Strengthen Medical Device Oversight

Concerns about the implantable birth control device Essure, manufactured by Bayer, are continuing to spread on a global level. Though Bayer will be suspending sales of Essure worldwide by the end of this month, questions still remain for thousands of women who have experienced pain and adverse reactions after having the device implanted.

Those lingering concerns and the stories of numerous women worldwide have prompted many countries to take more decisive action. This includes an order issued late last month by the Canadian Health Minister to strengthen regulations for medical devices, including improved standards for complication reporting, and stronger pre-market studies.

Essure: A Global Timeline of Pain & Adverse Health Complications

On our blog, we have featured many posts about the ongoing backlash over Essure, a small device comprised of a metal coil that can be implanted into the fallopian tubes for female sterilization. Although it gained popularity for being a minimally invasive and convenient form of birth control for women, and a purportedly safer option than tubal ligation, it has become the target of numerous concerns from patients, advocates, and regulatory agencies, as well as numerous lawsuits.

Today, more than 1 million women across the world have received Essure implants. However, reports of serious adverse reactions, years of physical and emotional pain, and thousands of painful removal surgeries linked to Essure soon prompted action from health regulators. That’s true in the U.S., where the federal Food and Drug Administration (FDA) issued a “black box” warning label and requirements for physicians to thoroughly discuss risks and issues with patients prior to implantation.

In Canada, a journalistic investigation by the Canadian Broadcasting Corporation (CBC) found a severe lack of adverse event reporting, despite hundreds of Canadian women voicing their stories and complaints, and growing evidence about Essure being approved with potentially incomplete evidence about its safety, including one 2015 study published in the New England Journal of Medicine. The investigation soon led to Essure being discontinued in Canada in 2017, and the Canadian Health Department’s recent decision to improve how it oversees the approval and reporting process for medical devices. Similar steps have been taken in other nations where Essure has been sold.

Regulatory Changes Welcomed, But Women Still Reeling

Though pledges to revamp regulations regarding medical devices, pre-market testing and approval, and reporting are certainly steps in the right direction, they do not detract from the fact that thousands of women have already suffered, and are still suffering, from complications related to Essure, including issues such as:

In light of the serious physical, emotional, and financial suffering endured by many women, the civil justice system has become the means through which they are sharing their stories, and which they hope will provide an opportunity for more information about what Bayer knew about Essure to come to light. Women who seek justice in Essure lawsuits may also recover financial compensation for their economic and non-economic damages.

Questions About Essure Lawsuits? We Can Help.

Bailey Cowan Heckaman PLLC, LLP is a nationally recognized trial firm that has earned a reputation for fighting on behalf of the injured and the wronged, including victims who suffer serious injuries and damages as a result of dangerous pharmaceutical drugs and medical devices like Essure.

If you or a loved one has experienced harm and losses after having Essure implanted, our award-winning attorneys are available to discuss your case and whether you may be able to join thousands of other women with pending lawsuits against Bayer. Call or contact us for a free and confidential review of your case.

Essure Complications Necessitate Surgical Removal in Thousands of Women

Over recent years, increasing evidence about the dangers posed by Essure has ignited significant backlash against Bayer, the pharmaceutical giant which manufactures and distributes the birth control device. In fact, critical safety risks and a growing number of lawsuits filed by women against Bayer have prompted to the company to publicly announce that it will stop selling Essure by the end of 2018. Unfortunately, for the many women who have already had the permanent birth control device implanted in their bodies, health problems don’t simply end with Essure being taken off the market.

While official statistics for the number of women who have had Essure implants removed are not readily available, experts suggest that thousands of women across the U.S. and other countries where the permanent birth control device is available have had to undergo removal procedures. What’s more, issues related to the device, which is implanted into the fallopian tubes, have also created various complications and health consequences associated with removal surgeries.

Essure & Adverse Health Complications

To date, over 1 million women worldwide have had received Essure implants. First approved in Europe in 2001 and the U.S. in 2002, Essure gained widespread attention after national health regulators, including the U.S. Food and Drug Administration (FDA), began to receive thousands of “adverse incident” reports from women. Those reports led to the issuance of numerous safety warnings, in addition to a number of lawsuits.

According to publically available records from the FDA, tens of thousands of women in the U.S. have reported health issues and complications linked to Essure, with an estimated 10,000 or more involving implant removal. There have also been at least eight deaths connected to Essure, including the death of women who suffered an embolism several days after undergoing a hysterectomy to remove the device.

Federal regulators are careful about definitively stating whether deaths were solely caused by Essure or other surgical complications, but their records do indicate many serious health risks associated with the birth control device. As the FDA notes, these most commonly include:

Women who undergo surgical procedures to remove Essure devices are also exposed to various risks, complications, and damages that could and should have been prevented had the device functioned as intended. These include:

If you or someone you love have experienced complications associated with Essure, including the need for any removal or reversal surgery, you may have the right to seek financial compensation for your losses. Thousands of women across the country have stepped forward to add their voices to a growing number of Essure complaints and pending lawsuits against Bayer, and our legal team at Bailey Cowan Heckaman PLLC is prepared to assist victims and their families as they navigate the legal journey ahead.

Bailey Cowan Heckaman PLLC, LLP is comprised of nationally recognized Houston trial lawyers who have extensive experience handling complex cases involving product liability and injuries and losses caused by defective drugs and medical devices. If you would like more information about your legal rights, whether you may have a potential claim, and how our award-winning attorneys can fight for you, call or contact us online to request a free and confidential consultation.

Women from Las Vegas Area Add Their Voices to Growing Number of Essure Complaints

The latest group of women seriously affected by Essure Permanent Birth Control System recently added their voices to the growing chorus of concerns about the medical device, which has been linked to perforated organs, severe pelvic pain, abnormal bleeding, and more.

“[My doctor was] like, ‘You need to have whatever you have inside your body taken out,’ ” Lorena Llamas, recalled of a November 2016 visit to an obstetrician-gynecologist. “I didn’t want any more kids, but I also didn’t want to completely lose the hope. At that moment in time, that was the loss of hope.”

Llamas received the birth control implant seven years prior. After years of dealing with serious health concerns including what she described as blood clots the size of her hand, her husband rushed her to an emergency room. Her doctor, the obstetrician-gynecologist informed her that she would need a hysterectomy to remove the device.

“The moment I woke up from anesthesia, I was a completely different person,” Llamas said. “It was like I was reborn.”

At this point, more than 41,000 women have shared their stories dealing with Essure, and an estimated 17,000 have filed lawsuits against the device’s manufacturer, Bayer. While Bayer continues to deny any issues with this product – which it pulled form shelves earlier this year – the evidence against these claims continues to grow.

“This is a medical device that was released prematurely, and there’s simply not enough data to know for certain (if it’s safe),” said Dr. E. Scott Sills, a reproductive endocrinologist in Carlsbad, California, who has removed hundreds of Essure implants. “It’s designed to cause inflammation. I think that the inflammation in some women becomes systemic.”

At Bailey Cowan Heckaman PLLC, our Houston medical device injury attorneys understand just how much damage Essure has caused to unsuspecting women across the globe. If you suffered serious side effects from this form of permanent and non-reversible birth control, then you may be able to take legal action. Call our offices today to discuss your options with a member of our firm, or send us your information through our online form and we will reach out to you as soon as possible.

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Women Continue to Come Forward to Speak About the Damage Essure Caused

New reports of women injured by Essure Permanent Birth Control System continue to flood the news across the globe. Recently, two women who are involved with the class action lawsuit against Bayer, the company that manufactures and distributes this product – at least until it leaves shelves at the end of the year – spoke about their experiences following the procedure to implant it.

“You get this birth control thinking, ‘Ok, I’ve done the best thing for me and my family,’ and it turns out to be the worst decision of your life,” says Latisha Montgomery of Rockford, IL. “It’s constant, it’s constant pain.”

“I went through hell for five years, absolutely hell,” says Ela Woolger of South Beloit, IL. “There were days I didn’t want to take care of my kid because I was so sick I couldn’t get out of bed.”

Latisha and Ela’s tragic stories are shared by tens of thousands of women in the United States alone. The U.S. Food and Drug Administration (FDA) has received an estimated 27,000 reports of adverse side effects caused by Essure. In response, the FDA forced Bayer to implement both a patient checklist and a black box warning on its product to ensure that people were fully informed when using its product. Despite these precautions, women continued to come forward to file complaints with the FDA, leading the administration to restrict sales of Essure in April of 2018 before Bayer announced that it was discontinuing sales of its product.

“The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen,” FDA Commissioner Scott Gottlieb, M.D. wrote in a statement posted on the agency’s website. “As the FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns.”

Our Houston drug injury attorneys at Bailey Cowan Heckaman PLLC continue to hear stories about how this permanent birth control device affects the lives of women across the country and around the world. If you suffered serious injuries caused by Essure Permanent Birth Control System, give us a call at to discuss your legal options with a member of our firm today. You can also send us your information through our online form to set up a case consultation and we will get back to you as soon as possible.

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Mother, Essure Patient Shares Her Struggles with Birth Control Implant

One of the women who joined in the class action lawsuit against Bayer over the permanent birth control implant Essure recently spoke out about the impact the implant has caused on her life.

“It has ruined my life completely and I really regret ever having it done,” said Nadi Nour, 41, a sales consultant and mother of three from Adelaide, Australia. “Each day has becoming a living hell because of these horrible side effects.”

She had the device implanted in her back in 2010, and in the eight years since stated that she’s gained a considerable amount of weight, suffers from severe pain after having sex, a reduced libido, cramps, chronic fatigue, migraines, depression, incontinence, and monthly bladder infections. These issues started appearing just months after the initial surgery.

“In just three months I'd gained 22lbs (10kg), which went up to 66lbs in the 18 months following the procedure,” she said. “I was doing everything right and there was no reason for me to be piling on the weight. It was so depressing. I've also become severely incontinent following the implant. Even after three kids, I never had problems with bladder control.”

Nour looked into the implant after deciding that her third child would be her last. A friend who had a positive experience with Essure recommended it to her, and after speaking with her doctor decided that it was the best option.

“I decided to talk to my doctor,” she said. “It seemed better than a hysterectomy because there was little to no recovery period. It sounded perfect. They just said it was a titanium rod that would stop me from ever getting pregnant.”

Nour is one of tens of thousands of women across the globe who have reported serious side effects caused by Essure. Some of the most dangerous and common side effects people have dealt with include:

While Bayer, the product’s manufacturer denies that its product is the cause of these life-changing side effects, it has pulled or is in the process of pulling Essure from shelves in countries like the United States, Canada, Australia, South Africa, the UK, and more.

If you suffered serious side effects caused by the permanent birth control implant Essure, contact our Houston product liability attorneys at Bailey Peavy Bailey Cowan Heckaman today. Our attorneys have decades of experience handling lawsuits for people seriously injured because of a defective product, and will use that knowledge to help you fight for and secure the maximum compensation possible. Call us today to discuss your situation over the phone, or send us your information through our online form to set up a free consultation with a member of our firm.

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