ESSURE BIRTH CONTROL
Cincinnati Essure Injury Attorney
On December 31, 2018, Bayer stopped selling and distributing the Essure birth control device in the United States. Bayer will continue to implement the FDA’s restriction on sale and distribution of Essure from April 2018, to ensure women are fully informed of the severe health risks associated with the device.
Since the Essure Birth Control System was brought to market in 2002 by Bayer AG, over a million units have been sold and implanted—the majority of the devices are marketed to American women. Essure is an invasive birth control device consisting of two metal coils inserted into the fallopian tubes to prevent unintended pregnancies.
However, the last 15 years have proven that the device is far from perfect, and thousands of women have reported serious injuries and health issues directly related to Essure implants. As of 2016, over 10,000 Essure-related medical device adverse event reports were submitted to the U.S Food and Drug Administration (FDA).
In February, 2016, the FDA ordered Bayer to conduct a 7-year study on Essure complications. In the meantime, injuries continue to accumulate and numerous class-action lawsuits have been filed against Bayer and pharmaceutical developers for failing to properly test the medical devices before bringing them to the market.
Essure has been linked to at least four adult deaths, 15 fetal deaths and hundreds of unwanted pregnancies. The FDA has received countless other reports of serious side effects, submitted by physicians and suffering patients.
Any patient with an injury due to implantation of an Essure Birth Control System may have a successful claim and can recover mounting medical costs, lost wages, and damages for physical and emotional trauma.
Joe Lyon is a highly-rated Cincinnati product liability lawyer and Ohio toxic tort attorney representing plaintiffs nationwide in a wide variety of civil litigation claims against pharmaceutical and medical device companies.
Bayer Halts Essure Sales
Due to longstanding safety concerns related to the Essure birth control device, the U.S. Food and Drug Administration (FDA) has taken action and announced significant new requirements on the device use.
Bayer has said that Essure will no longer be sold or distributed in the U.S. after Dec. 31, 2018. Years of patient complaints, injuries and legal pressure have taken its toll on the company. However, many injured patients may still be suffering as a result of the defective medical device.
The FDA has taken several steps with warning about Essure, a permanent birth control device, though failed to completely recall the product. The FDA has evaluated Essure’s long-term safety risks and eventually made Essure a “restricted device.”
Even in 2019 when Essure is no longer sold in the United States, the FDA will still oversee the device, requiring Bayer to complete the post-market surveillance study ordered in 2016.
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ABOUT THE LYON FIRM
Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.
The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.
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The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.
What is Essure?
Essure is a birth control system that over time creates a barrier in the Fallopian tubes that keeps sperm from reaching the eggs, thus preventing conception.
The U.S. FDA approved the Essure Permanent Birth Control System in 2002. Bayer AG, the current manufacturer, says about 1 million of the devices have been sold globally, the majority in the United States.
However, thousands of women are filing birth control injury lawsuits, and making claims that Essure has caused significant damage to their bodies. The FDA has received reports of pregnancy losses in women who became pregnant following Essure placement.
Bayer admits that women who have had the Essure placement procedure are more likely to have a pregnancy outside the uterus (ectopic pregnancy) than women who have not had the Essure placement procedure. This can be life-threatening.
How Does Essure Work?
The Essure system consists of two metal coils implanted in each Fallopian tube. The device itself is a small, flexible coil made from an alloy of nickel and titanium. A doctor inserts the coils in a procedure that typically takes less than 15 minutes.
Scar tissue is meant to develop in the tube to prevent fertilization. After about three months, tissue is supposed to form around the inserts, blocking the tubes and permanently preventing pregnancy. While scar tissue forms, women are urged to use an alternative form of birth control.
Dangerous Side Effects
The most commonly reported complication of Essure is pain following surgery. In almost 10,000 reports analyzed, pain is mentioned in nearly every one. Making matter worse, sometimes the pain does not subside. Chronic pelvic pain, abdominal bloating, migraine-type headaches and severe fatigue appear to be most common adverse health events reported. Other complications include:
- Headache
- Fatigue
- Weight changes
- Hair loss
- Depression
- Allergic or hypersensitivity reactions
- Joint or muscle pain
- Nausea and vomiting
- Dizziness
- Muscle weakness
- Vaginal bleeding
- Abnormal weight gain
- Abdominal bloating
- Hives and rashes
- Impairments of short-term memory
Essure Birth Control Risks
The US Food and Drug Administration (FDA) announced that it will require German drug maker Bayer AG to begin new safety studies on its permanent birth control device Essure. Later, the company decided it was not worth the trouble and stopped producing the device for the US market.
The FDA also required a “black box” label warning about the device’s potentially serious side effects, something the drug company has resisted in the past. In addition to the new boxed warning, the FDA will require a “Patient Decision Checklist” to help ensure women receive and understand information regarding the risks of this type of device.
Thousands of women have complained about suffering complications from the implant. As a result, women are beginning to speak out and file lawsuits. Women claim the device has caused permanent birth control injury, including autoimmune diseases, perforated organs and severe pelvic pain.
Among the thousands of reports the FDA had received about Essure, 631 women report becoming pregnant after receiving an Essure implant. Of those, 294 included pregnancy loss.
Recently, experts have questioned the FDA reporting process and have found that risks associated with Essure are significantly higher than reported.
Compared to women who have sought alternative, minimally-invasive sterilization operations, women who receive Essure implants are ten times more likely to need a second operation, according to a study published in the British Medical Journal. Other long-term risks to patients reported to the FDA include:
- Unintended pregnancy
- Depression
- Ovarian cysts
- Chronic abdominal, pelvic or back pain
- Abnormally heavy menstrual periods on a recurring basis
- Perforation of the uterus or fallopian tubes
FDA Warnings
Bayer insists the device is effective when inserted properly. The U.S. Food and Drug Administration announced actions to provide important information about the risks.
Dr. William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health, stated that “more rigorous research is needed to better understand if certain women are at heightened risk of complications.”
The FDA’s recent decision requires Bayer to conduct a new study designed to “provide important information about the risks of the device in a real-world environment.” Now the company must follow patients who receive the device, and monitor problems.
This includes noting the rates of complications including unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the device. The study will also evaluate how much these complications affect a patient’s quality of life.
While scientific evidence shows that Essure is an effective means of sterilization, hundreds of unintended pregnancies have occurred. Some neonatal or pregnancy complications have been reported and the FDA has received reports of pregnancy losses in women who became pregnant following Essure placement. There may also be a risk of pregnancy outside of the uterus (ectopic pregnancy), likely to result in serious complications.
Essure Birth Control Injury
In April 2018, the Food and Drug Administration (FDA) commissioner announced that the safety agency imposed “unique” restrictions on sales of permanent contraceptive device Essure, due primarily to Essure implant injury risks, and an “unacceptable” number of women being implanted without full knowledge of Essure implant injury risks.
The FDA said in their statement that despite other efforts to alert women to the potential complications of Essure, many patients still aren’t receiving important information.
Now, Bayer will only be authorized to sell the device to health-care providers that collect signatures confirming that patients have received a detailed checklist explaining known Essure implant risks. Consumer advocates, attorneys and the FDA are working to detail injury claims and make certain they are being taken seriously to protect women.
Commonly reported adverse events associated with the Essure device include device migration, allergic reactions and chronic pain. Though rare, more severe adverse events have been reported, like the perforation of the uterus, and fetal deaths.
Essure Implant Complications
The Black Box warning clarified the potential need to have the device removed. According to the FDA website, the labeling on Essure birth control packaging is “designed to call attention to serious or life-threatening risks.” Before the device is implanted, a checklist must also be provided to the patient to make sure they understand the risks.
The most commonly reported adverse events associated with Essure have included device migration, allergic reactions and pain. However, more severe events have also been reported, such as perforation of the Fallopian tubes or uterus, and fetal deaths.
If a woman becomes pregnant with Essure, there may be a risk for the pregnancy to occur outside of the uterus, which may result in serious complications. The FDA continues to monitor the safety of this device. Many women have had surgical procedures to remove the device.
The FDA has received over 26,000 medical device reports of injuries reportedly caused by Essure implants, including life-threatening ectopic pregnancy, miscarriages, device migration, and perforated organs. A painful revision surgery is usually required to remove the device in these cases. Short-term and long-term adverse events reported by doctors and Ohio patients include:
- Abdominal or pelvic pain
- Back pain
- Perforation of the uterus
- Device migration
- Irregular bleeding
- Weight changes
- Hair loss
- Auto-immune disorders
- Device failure
- Mood changes
- Joint or muscle pain
- Allergic reactions
- Unintended pregnancies
Essure Settlements
According to an analysis, 303 fetal deaths have been linked to the Essure contraceptive. The U.S. Food and Drug Administration (FDA) greatly underestimated the rate of fetal deaths among women who became pregnant after they used the contraceptive device; they initially only reported five fetal deaths.
The Food and Drug Administration blamed a computer glitch for the inconsistencies in its safety data, and is now taking responsibility for the mistake.
Opponents of the device have waged a social media campaign to see that Essure is pulled from the market. There is a large Facebook group called Essure Problems, where thousands of female members share stories about health problems they have experienced after receiving the device.
The issue is so widespread in communities that congress has also questioned the device and Bayer’s intentions. Rep. Mike Fitzpatrick, a congressman from Pennsylvania, has pushed the FDA to halt the device’s use. He has asked why the agency would allow Bayer to conduct their own safety studies, rather than have an independent party complete a report.
Essure Lawsuits
Since Essure hit the marketplace, doctors and patients reported hundreds of problems. The discontinued device further indicates the potential danger the device can pose to women. Thousands of lawsuits have been already been filed against Bayer for a number of adverse health outcomes with many more expected with the device still on the market.
Even before the latest word from the FDA, Fitzpatrick publicly urged the agency in a letter to review an independent report that counted 303 fetal deaths.
Rep. Rosa DeLauro, from Connecticut added to the pressure by saying recently, “Essure should be off the market until the requested studies are completed.”
Bayer, the device manufacturer, downplays any Essure Implant risks, and maintains the device is safe to use, despite evidence that injuries are rather common. The concerns of experts are not new, however. The FDA first added a black box warning to Essure implant labeling back in 2016. A black box warning is the safety agency’s highest warning level and indicates that a product can cause serious injuries or death.
Since Essure was introduced in 2002, doctors and patients have reported hundreds of health issues. More recently, Bayer was forced to adhere to new labeling requirements clarifying the potential risks the device poses to women.
But in many cases, the damage has already been done. As a result, thousands of injured plaintiffs have filed claims against Bayer.
Why are these cases important?
Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.
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Questions about Defective Medical Device Litigation
Ohio Definition of Defective
Under Ohio law, a medical device is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of medical device product defects. Most jurisdictions a version of one or more of these cause of actions.
(1) Manufacturing/ Construction Defect of the medical device:
(2) Defective design and/or formulation of the medical device:
(3) Failure to warn or inadequate warning or instruction associated with the medical device:
(4) Misrepresentation on the Safety or Efficacy of the Medical Device:
(5) Fraud Related to the Safety or Efficacy of the Medical Device
(6) Negligent Distribution or Testing of the Medical Device
- Hernia Mesh
- Breast Implants
- Transvaginal Mesh Implants
- Catheters
- Hip Replacements
- Knee Implants
- Shoulder Replacements
- Heater Coolers
- Bone Grafts
- Ventilators
- Defibrillators
- IUD
- IVC Filters
- Da Vinci Robot Surgery System
Medical Device Manufacturers
- Atrium Hernia Mesh
- Bard Hernia Mesh
- Bard IVC Filters
- Covidien Hernia Mesh
- Depuy Hip Implants
- Arthrex knee replacement
- Exactech knee replacement
- CareFusion ventilators
- Essure Birth Control System
- Ethicon hernia mesh
- Infuse Bone Grafts
- LivaNova Heater-Coolers
- Stryker Hip Implants
- Smith & Nephew Hip Systems
- Zimmer Biomet Shoulder Systems
- Wright Medical Hip Implants
Defective design medical device cases arise not because a mistake was made during the manufacturing process, but rather the original design of the product is unreasonably dangerous. A “risk-benefit analysis” is used to determine whether safer/less expensive alternative designs were available to the manufacturer (e.g. the metal on metal design, the porosity and stiffness of transvaginal mesh )
For these claims, the FDA Review process is critical on whether a pre-emption defense exists. For devices that went through the PMA (pre-market approval process), rather than the 510K process, the case must be evaluated very carefully for any parallel claims under state and federal regulations (e.g., failure to warn or failure to disclose adverse events) that can advance the case forward. Without a careful legal analysis, the case may be subject to dismissal even where the medical device design proves to be defective.
Risks: The following factors are considered under Ohio law when determining the risks associated with the design of a medical device: (1) the magnitude of the risk of injury; (2) ordinary consumer awareness of the risk for injury; (3) the likelihood of causing injury; (4) the violation of a private or public standard; and (5) the consumer’s expectation of the performance of the product and level of danger. Ohio Revised Code 2307.5 (B) Product Defective in Design or Formulation. These factors are considered in most other jurisdictions.
Benefits: The following factors are considered under Ohio law when determining the benefits associated with a medical device: (1) the utility of the product; (2) availability of an alternative design; (3) the magnitude of risks associated with an alternative design. Ohio Revised Code 2307.5 (c) These factors are considered in most other jurisdictions.
Defenses for Defective Design: (1) a pharmaceutical drug or medical device is not defective by design if it contains an adequate warning of an unavoidably unsafe aspect of the pharmaceutical or medical device; (2) the dangerous aspect is inherent to the product, recognizable, and cannot be eliminated without compromising the product’s usefulness; (3) a lack of a feasible alternative design. 2307.75 (d)(e)(f).
A manufacturing defect claim arises where the medical device is released from the factory in a manner that deviates from the intended design or specifications.
Most manufacturing defect cases are based on a products deviation from the intended specification, formula, performance standards, or design model. In such cases, it may be easy to determine the product did not comply with the intended design. In defective medical device cases, the manufacturing defect is often related to performance standards (e.g., the metal does not meet the strength specification or has microscopic fractures–these defects require an examination by a qualified metallurgist who can examine the medical device).
As a result of the deviation, the product enters the market in an unreasonably dangerous condition and the consumer is exposed to or purchases a product that is defective. Any personal injuries or economic loss that arise from the the defect are compensable under Ohio product liability law.
The product may be recalled as a specific lot is identified as being non-compliant and defective. A product may be defective in manufacture or construction, materials and assembly, and a manufacturer or distributor may be subject to strict liability, even though it exercised all possible care. Ohio Revised Code 2307.74.
All medical device products come with warnings and instructions for use that are provided to the physician. If the company does not provide the physician with all the relevant safety data so that the physician adequately understand the risks and benefits of the product, then the medical device is defective.
The physician must be in a position to pass the appropriate safety data onto the patient, so the patient can make an informed decision on whether they wish to have the medical device implanted. Patient informed consent is critical because many devices are designed to be permanent.
Litigation arises where there is evidence the medical device manufacturer failed to timely update a warning in light of new data or simply ignored the risk and failed to conduct sufficient research to identify and then disclose the risk.
In determining whether a medical device is defective due to inadequate warning or instruction, evidence must be presented to prove:
- The medical device manufacturer knew, or in the exercise of reasonable care, should have known about a risk
- A reasonable medical device manufacturer would have provided a warning of the risk
- The medical device manufacturer failed to provide the warning
- The patient was injured due to a lack of warning. The same elements apply whether the claim is based on a warning present during the marketing or post-sale warnings.
Defenses to Failure to Warn Claims: (1) the risk was open and obvious or a matter of common knowledge; and (2) in cases of a pharmaceutical drug or medical device, the warning was provided to the prescribing physician (“Learned Intermediary Doctrine”).
Design and manufacturing defects result in medical device product recalls each year in the United States, initiated by federal safety agencies.
The foregoing listed government agencies may initiate recalls of dangerous products but do not provide remedies or compensation for damages where an individual is injured due to the defective product. Only litigation can utilized to compensate patients injured by a defective medical device.
Our Firm will help you find the answers. The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered.
Experience: Joe Lyon is an experienced Cincinnati Defective Device Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Defective device lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.
Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.
Results: Mr. Lyon has obtained numerous seven and six figure results in medical device cases. He has litigated cases successfully against some of the largest companies in the world including: Johnson & Johnson, Biomet, Ethicon, Stryker, Coloplast, Smith & Nephew, American Medical Systems, Boston Scientific, Medtronic, Guidant, Bard, & Bayer.
Learn about Medical Device Approval Processes
The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a defective product or recalled product to obtain just compensation under the law.
IN RE: DEPUY ASR
METAL ON METAL HIP IMPLANTS
Nationwide Consolidation in U.S. District Court, Northern District of Ohio. The Depuy ASR Hip design was plagued with problems related to premature loosening and metallosis, caused by chromium and cobalt entering the blood stream. The resulting injuries were a result of the metal-on-metal friction inherent with the design of the product. Depuy recalled the ASR and entered into a global settlement valued at $2.5 Billion to cover an estimated 8,000 patients. The Lyon Firm represented several clients in the original settlement and continues to be active in this litigation. The settlement funds provided compensation for the revision surgeries, including compensating for medical costs, lost wages, and pain and suffering.
IN RE: BIOMET MSA MAGNUM
METAL ON METAL HIP IMPLANTS
Nationwide Consolidation in U.S District Court, Northern District of Indiana. Similar to the Depuy ASR, the Biomet metal-on-metal hip design allegedly contributed to premature hip failures and metallosis due to the metal friction. Biomet entered into a global settlement valued at $56 million to cover a few thousand claims. The Lyon Firm represented several plaintiffs in the original settlement and continues to be active in this litigation.
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