You trust medical manufacturers to make your life better. However, the manufacturers of Essure permanent birth control system failed that responsibility and caused immeasurable pain and suffering for many thousands of women.
Many women have had to undergo surgery or multiple surgeries from Essure injuries. Though the Essure insertion procedure may be noninvasive, the aftereffects for around one in four women have been extremely painful and invasive. If you have undergone a hysterectomy or other Essure removal surgery after suffering serious injuries, you need to speak to an attorney now. Isaacs & Isaacs injury lawyers will fight to get your just compensation for your pain and suffering. Call us anytime at 800-333-9999. We’re here for you 24/7.
Women Suffering Essure Complications Were Treated With Condescension and Ignored
Many doctors have refused to listen to victims’ complaints about intense abdominal pain, abnormal bleeding and other horrific side-effects and injuries from this defective medical device. Isaacs & Isaacs compassionate but aggressive attorneys will listen to your story, and together we will decide what we can do next to demand justice.
Essure tubal sterilization is a form of permanent birth control that is supposed to be a better alternative than laparoscopic tubal ligation. Essure uses two small metal spring-like coils that are placed in the fallopian tubes. During the three months following placement of the coils, scar tissue is supposed to develop around them that permanently blocks the fallopian tubes, preventing pregnancy. The inserts are made of stainless steel, polyethylene terephthalate fiber and a nickel-titanium alloy.
The coils are inserted by a doctor using a non-invasive procedure that is advertised as only taking around ten minutes and requires no anesthesia. After the coils are inserted, the patient is supposed to continue using other birth-control for a minimum of three months until a test confirms the fallopian tubes are completely blocked.
Essure problems started for thousands of women as soon as the coils were inserted. Yet, Bayer continues to insist that the implants are a safe and effective form of permanent birth control for most women. The question is how great is the risk, and what are the negative side effects? The United States Food and Drug Administration has refused to recall the implants, despite over 17,000 women who have complained of life-altering, negative side-effects and mounting evidence that the company that developed the implants, Conceptus Inc., hid negative test results and changed the answers some of the women who participated in the required post-market study gave to questions.
Previously, women who tried to recover damages for their injuries from Bayer were prevented from moving forward with lawsuits. However, with thousands of serious complaints filed on the FDA website, a Pennsylvania Senator introducing a bill, the E-Free Act, to Congress, and mounting evidence that Conceptus hid or changed clinical trial results, courts are beginning to rule in favor of plaintiffs in these lawsuits.
Essure Device Approval
The FDA approved Essure for marketing in 2002. The original manufacturer was Conceptus. Bayer, the pharmaceutical giant, bought Conceptus in 2013 for $1.1 billion. Detailed, inclusive post-market studies required of Conceptus by the FDA were not done within the five-year mandatory time frame. Instead, Bayer submitted a marginal report in 2015, failing to take into account all women who received the device. This bypasses some of the serious consequences women experienced.
Using the FDA pre-approval process, which in the case of Essure called for rigorous testing for a Class III device, Bayer has sought to protect itself from local laws concerning consumer protection against harmful drugs and devices. However, the FDA Essure pre-approval study did not include a control group of women who did not get the device, a flaw in the study that has drawn criticism.[iv] Bayer has invoked the doctrine of preemption that basically says federal laws trump local laws, as a defense.[v] However, courts in Pennsylvania[vi]and California [vii] have made rulings that may allow the local lawsuits to move forward.
Recently, the FDA has added a black box warning to Essure in response to the thousands of complaints that women, their physicians and attorneys have posted on the FDA website. One has the feeling that the FDA is trying to placate victims with a lesser action than the Essure recall they have demanded, and which Congressman Mike Fitzpatrick of Pennsylvania introduced in a bill known as the E-Free Act to attempt to legislate this issue.
Most recently, Congressman Mike Fitzpatrick (R-PA) and Congresswoman Louise Slaughter (D-NY) introduced a bipartisan package of bills aimed at reforming the medical device approval process and increase accountability and legal recourse for victims of harmful medical devices. The bills are aimed at providing needed reform of the FDA and legal recourse for victims who are harmed by FDA-approved medical devices.
Hidden Essure Complications
One study found that nearly 10 percent of women who use the Essure “permanent” sterilization method can get pregnant within 10 years. This is nearly four-times the risk of pregnancy after the Essure procedure than having laparoscopic tubal ligation.[ix]
Along with a substantially higher risk of pregnancy, there are many other serious side effects that women were not warned of until recently. So far, 17,000 women have complained about side effects out of Bayer’s estimated 75,000 women who’ve had the implants. That averages around one woman in four who has had serious complications, which many women say started right away after the procedure and changed their lives immediately.
A study published in the British Medical Journal found that there’s more than 10 times the risk of needing a reoperation in the first year after getting Essure compared to tubal ligation.[x]
Complications and side effects include:
- Ectopic pregnancy
- Abdominal pain
- Excessive bleeding
- Organ perforation
- The coil breaking apart
- Allergic reaction to nickel
- Death [xi]
These outcomes were reported as early as 2003, a year after the Essure coil went on the market. [xii]
Worse yet, women who participated in the required clinical trials said the company changed their answers to questions.[xiii]
Some women became ill after having the coils inserted, but it took them years of pain to connect the dots and realize that the problems were caused by Essure. This may be due to trusting their doctors’ and the company’s assurances that Essure is safe.
Long-term irreversible damage women have reported includes:
- Autoimmune disorders [xiv]
- Cervical cancer
- Rheumatoid arthritis [xv]
- Neurological damage
If you have metal like the Essure coils in your body, you cannot have magnetic resonance imaging. This could make it a lot more difficult for your doctor to determine what’s causing other problems or to find a missing coil that has broken apart or migrated. MRI is a method doctors use to examine organs and tissues without the need for surgical intervention. Though Essure is advertised as noninvasive, it has caused women huge problems that required multiple surgeries.
Can Essure Coils Be Removed?
According to one doctor, the coils aren’t like other forms of birth control because they’re designed to remain in the patient’s body permanently. Removal is a problem that few doctors are willing to deal with. Many women have resorted to complete hysterectomies in order to rid themselves of the harmful coils.
However, women who undergo hysterectomies are in danger of pelvic organ prolapse, another serious and painful medical condition which requires surgery and causes major problems. In some cases where the coil has fragmented or disappeared into the body, this extreme measure isn’t even an option. One Texas doctor performs a surgery called the Essure reversal. He charges $6,000 for the procedure and insists on being paid in cash.
Some procedures currently being used to remove the Essure coils include:
- Salpingotomy is where a small incision is made into the fallopian tube, and the coil is pulled out. Coils have been known to fracture in this procedure, and more surgery is required to remove the pieces.
- Salpingectomy is complete removal of the fallopian tubes. This surgery has been performed with some success on women who did not wish to become pregnant (Essure reversal) and wanted the coils out. The surgery can be performed in a minimally invasive laparoscopic procedure. Risks from this procedure include abdominal compartment syndrome, a condition where you could suffer abdominal pain, bowel dysfunction and renal failure. Further surgery is required to correct this condition.
- Tubal anastomosis is a procedure used for tubal ligation reversal and Essure reversal, if the patient wants to reverse sterilization and allow pregnancy. The process reconnects the fallopian tubes after the coils are removed. Pregnancy after having this procedure can be dangerous for both the mother and the baby.
- Complete hysterectomy is the removal of the uterus and fallopian tubes. This is a drastic step and should be discussed with your doctor. This step might be appropriate if the Essure coils migrated into your uterus or broke up, and pieces migrated or caused other problems. If your surgeon wants to perform a laparoscopic hysterectomy using a surgical robot, robotic surgery could cause further complications and injury.
What Is Federal Preemption, and How Could Medical Device Manufacturers Hide Behind It?
Federal preemption is based on the United States Constitution’s Supremacy Clause that states that U.S. law is the supreme law of the land and overrules any conflicting state law. Federal preemption as it applies to medical devices refers to the Medical Device Act of 1976, which granted the Food and Drug Administration the authority to regulate medical devices. States cannot require medical devices to meet additional or different standards than those imposed by FDA oversight. However, the Medical Device Act only applies to Class III devices, which are presumed to adhere to the rigorous FDA standards for premarket approval.
Essure is an FDA Class III medical device; therefore, it has been extremely difficult for victims who have been harmed by Essure to recover compensation by bringing tort actions in state court. Last March, Judge John R. Padova, a federal judge in the Eastern District of Pennsylvania, allowed five Essure lawsuits to move forward against Bayer on limited grounds.
The complaints alleged:
- The device migrated from the fallopian tubes to the uterus, rectum or colon
- In four cases, removal of the device required hysterectomy
- In the fifth case, the fallopian tubes were removed after bearing a baby with birth defects
Other injuries the five victims suffered included:
- Severe pain
- Hair loss
- Eyesight problems
- Fainting spells
The above are just some of the Essure side effects these five women experienced.
Judge Padova granted permission to the plaintiffs to revise their complaints and move forward on:
- Negligent training
- Negligent risk management
- Breach of express warranty
- Fraudulent misrepresentation
- Negligent manufacture
A Civil Lawsuit With an Essure Implant Law Firm May Be the Only Path to Justice
Because of thousands of Essure complaints worldwide, additional studies have been done that show results regarding Essure efficacy that are different than company claims. Women have now come forward who volunteered for the required United States Food and Drug Administration clinical trials, alleging that some of their answers to questions were changed in order to skew the clinical trial results. Last year, a bill was introduced to Congress, known as the E-Free Act, specifically asking for Essure to be recalled.
In response to a public outcry and demands for an Essure recall, the FDA recently added a black box warning to Essure and also a checklist requiring doctors to advise women of Essure risks prior to the procedure. Women are supposed to sign the checklist, showing that they have now been warned.
However, many women who trusted their doctors and medical advertisements, which assured them that Essure is a safe, noninvasive form of permanent birth control, have filed lawsuits across the country to demand justice and compensation for serious injuries such as:
- Chronic, debilitating pain
- Removal surgery
- Ectopic pregnancy
- Migration of Essure coils
- Punctured organs
- Death (filed by family member as a wrongful death lawsuit)
Women who file lawsuits against Bayer want and deserve just compensation for their painful ordeal. Yet, for some women, perhaps an even greater motivation is to hold Bayer accountable for their pain and injuries. Some serious injuries were corrected after the coils were removed, and some injuries are permanent. Because Essure is a Class III medical device, it has been difficult going forward with these lawsuits. Class III devices are protected by federal preemption rules, which make it extremely difficult for victims to recover compensation for damages they suffer from a Class III device. However, perhaps in response to the collective voice of thousands of women around the world who are trying to warn others, judges are now allowing the Essure lawsuits to move forward.
Mending the Legal Loophole
Along with providing some relief to women who have suffered serious injury and financial damages, Essure lawsuits may also develop into landmark rulings that could help future victims hold medical device manufacturers responsible for the injuries and suffering their products can cause. Prior to Essure lawsuits, a federal judge has held that preemption does not apply to devices approved under the FDA’s less rigorous 510k approval process, which provides a fast track for a device to be approved that is substantially similar to a device that was FDA approved prior to 1976 (a predicate device).[xxii]
A major issue that has prevented victims from proceeding with an Essure lawsuit is whether a medical device that underwent FDA approval processes is protected under the doctrine of federal preemption. A federal judge has ruled that the lawsuits can proceed in Pennsylvania, and most recently, a California judge ruled against Bayer’s preemption defense, allowing several lawsuits to proceed on limited grounds.
Grounds for Essure Birth Control Lawsuits
Grounds against Bayer that have been allowed by a federal judge in Pennsylvania complaints include:
- Negligent manufacture
- Negligent risk management
- Breach of express warranty
- Negligent training
- Fraudulent manufacture
California Essure complaints allowed include:
- Negligent misrepresentation
- Failure to warn
The California court ruled against several of Bayer’s defenses including, most significantly, federal preemption protection.
Since this victory for Essure plaintiffs in federal court, cases have moved forward in state courts and are snowballing. On August 2, in California Superior Court, Alameda County Judge Winifred Smith allowed 11 suits filed by 14 women against Bayer to move forward.
A recent California Supreme Court ruling broadened the right to sue companies that do business nationwide in California courts. The ruling led many plaintiffs against Bayer to file their cases in California. Most recently, a California judge granted a motion coordinating 55 cases involving over 900 women who have suffered serious injuries from Essure implants. Some of these plaintiffs are from other states.
Isaacs & Isaacs Lawyers for Dangerous Medical Devices
If you have suffered a serious injury from Essure birth control inserts, Isaacs & Isaacs Essure lawsuit attorneys will help you to demand fair compensation for all of your damages. We’re tired of medical device companies hiding behind the federal government in order to get away with causing serious injuries to thousands of people. We will fight to hold Bayer accountable for the suffering and damages it has caused you and your family. Our experienced and aggressive attorneys will work hard to make sure that you receive every dollar of compensation you deserve.
Time is extremely important in filing your claim. If you wait too long, you could be barred from recovering compensation by a legal deadline called a statute of limitations. Do not delay contacting our firm at 800-333-9999, or filling out a form to speak with an experienced Isaacs & Isaacs Essure lawsuit attorney about your claim. We are standing by to help you around the clock.
You don’t have to have any money to enlist our help. Isaacs & Isaacs Personal Injury Law Firm will bear the cost of investigating and litigating your Essure lawsuit. We have the resources to:
- Investigate your claim
- File your lawsuit
- Prove liability for your damages
- Demand your maximum compensation from Bayer and all liable parties.