You trust medical manufacturers to make your life better. The manufacturers of Essure permanent birth control system failed that responsibility and caused immeasurable pain and suffering for many thousands of women. Have You Suffered From Using Essure? Isaacs & Isaacs Essure attorneys will help you to obtain justice and demand maximum compensation for your pain and suffering. Call us now at 800-800-888, or fill out our form for a no-obligation claim evaluation.
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.[i]
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.[ii]
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.[viii]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 [xvi]
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.
Reasons for Essure Birth Control Lawsuits
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,[xvii] and mounting evidence that Conceptus hid or changed clinical trial results, courts are beginning to rule in favor of plaintiffs in these lawsuits.
Grounds against Bayer that have been allowed by a federal judge in Pennsylvania complaints include:[xviii]
- Negligent manufacture
- Negligent risk management
- Breach of express warranty
- Negligent training
- Fraudulent manufacture
California Essure complaints allowed include:[xix]
- Negligent misrepresentation
- Failure to warn
The California court ruled against several of Bayer’s defenses including, most significantly, federal preemption protection.
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. 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. [xxi]
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.
Isaacs & Isaacs Essure Class Action Lawsuit Attorneys
Isaacs & Isaacs attorneys and legal support professionals are tired of seeing big companies get away with ruining people’s lives. We are appalled at the ordeal Essure victims have suffered and the difficulties they face when they try to get the coils removed. We are relieved the lawsuits are being allowed to proceed and are prepared to fight to demand justice for all your suffering and pain.
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.
If we don’t get you your just compensation, we won’t get paid.
If you have been harmed by Essure sterilization coils migrating in your body, perforating your organs or have had problems getting the coils removed, give us a call immediately at 800-800-8888, or fill out our form for a consultation with an experienced, aggressive and compassionate Isaacs & Isaacs personal injury attorney. We are available 24/7 to listen to your story and help you to demand justice for your suffering.