Essure Lawsuit: Woman Claims Perforation of Reproductive Organs

Essure Lawyer

As a Tennessee, Arkansas and Kentucky lawyer looking at Essure injury claims, I wanted to provide the following information.  New Essure lawsuit claims continue to be filed, as the call for market withdrawal of the birth control device is growing louder. A South Carolina woman, in one of the latest litigations, has sought product liability against the transvaginal device maker Bayer. According to the Essure attorney representing the lawsuit, the coil-shaped contraceptive broke inside the plaintiff’s body and damaged her fallopian tube beyond repair.

Filed in a California federal court, the Essure lawsuit claims of persistent pain and bleeding following the transvaginal birth control device implant. Tanya De La Paz, the plaintiff, was told by her doctor that the contraceptive coil implanted had “broken or stretched” inside her body. The injury so severe that she underwent removal surgery and her fallopian tube was resected.

The plaintiff had severe bleeding when she went for her first Essure implant that was unsuccessful. She had the perforation during the second implant and side effects, including severe pain, were visible within three months. It was removed two months later.

Essure Lawsuit and Recall Demands Continue

With large number of Essure injury reports going public and lawyers continue to file claims across the United States, the clamor for FDA recall is getting strong. The transvaginal contraceptive, a bendable coil, is implanted into the fallopian tube in an outpatient procedure. It has to be inserted through the vagina and uterus. Many women have complained of scar tissue formation and damage to cervix during the implant. Vaginal bleeding and uterus perforation are other most-occurred injuries cited by Essure lawsuit plaintiffs.

Until May 2015, The FDA had received at least 5,000 Essure side effect reports and a large number of such injuries point out the need for the removal surgery. The large volume of claims and prospective lawsuits every Essure attorney flooded with lends credence to the demand for safety reassessment of the birth control device.

A recent study reported in the British Medical Journal warns that an Essure birth control implant put women 10-fold higher risk of surgery and secondary surgical complications compared to tubal ligation. Attributed to scholars from New York’s Weill Medical College, the study took into account the history of over 50,000 women, who had either of the two sterilization processes, monitored over a one-year period.

Those with Essure birth control had “pelvic inflammatory disease, major abdominal surgery, or cesarean section,” the study found. Women suffered from Essure injuries and side effects forcing them to undergo removal and other surgeries. The incidence is 21 in every 1,000 women who received the transvaginal implant.

A large number of women, including those who have filed Essure product liability lawsuits claiming injuries, attended the FDA hearing on the birth control safety. They demanded the revocation of approval given to the transvaginal contraceptive. The review was a foregone conclusion after a Facebook group relentlessly campaign highlighting Essure side effects and encouraging women to report side effects and file Essure lawsuit claiming product liability.

Contact our Essure injury attorney or call on 1-800-632-1404 to explore options for filing Essure injury lawsuit and seek compensation and damages for suffering from complications associated with the birth control device. 

“Essure Problems” Seek Congressional Probe into FDA Failure To Recall Essure Birth Control Device

Essure

As thousands visit Essure injury lawyers to explore possibility of product liability lawsuit over Essure side effects, an advocacy group is seeking a Congressional probe into FDA oversight of the birth control device. The 30,000-strong Facebook group “Essure Problems” with hundreds of women who had harrowing tales to tell about Essure side effects has been vocal against the FDA’s failure to recall the contraceptive. It alleges that the FDA did not take into account the many reports of Essure injuries despite “inadequate and inappropriate clinical trials from the beginning.”

In a letter addressed to Jason Chaffet, who heads the Congressional Committee on Oversight and Government Reform, the group highlighted following potential reasons to believe that the FDA oversight of the Essure birth control is not up to the mark.

  • Approval Without Sufficient Clinical Trials

The advocacy group claims that the FDA approved Essure without adequate clinical trials. Only two non-randomized, non-blinded studies were conducted. Of the 926 women selected, 181 dropped out and only a fourth subjects were followed for 2 years. There was no control group, which limited an effective assessment of the Essure side effects.

The post-marketing studies were also surrounded with controversies. According an article published in the New England Journal of Medicine, Essure birth control approval is an example of “lack of thorough examination, no well-conducted premarketing clinical trials, and absence of dedicated follow-up in post-marketing studies.” At least 27 women recruited for trials are now part of Essure Problems and openly discuss how the contraceptive forced them to suffer from complications, including post-placement surgery. There were also no trials to assess the side effects of PET fibers in the Essure coil.

  • No Attention To Essure Side Effect Complaints

The FDA, according to Essure Problems, turned a blind eye to adverse event complaints. Despite 10,000 Essure side effect reports to the regulator and discovery of another 32,000 underreported incidents, it took no action. Making matters worse, the FDA did not comply with the request for a meeting by the advocacy group to discuss Essure injury facts for years.

The group even claims that medical reports of trials were altered and Essure side effect complaints were not acknowledged or reported. In 2016, the FDA admitted an error in reporting the problems associated with the birth control.

  • Delay in Safety Warning

Despite thousands of Essure side effect complaints, the FDA delayed in issuing safety warnings. It admitted inaccurate reporting and intentional misrepresentation of safety data, but took no action. Even a November 2015 warning about “dangers of Lubricious Coating Separation” was not extended to Essure contraceptive coil.

Essure Problems also cites the FDA’s failure to rein in “highly aggressive marketing tactics” by the manufacturer making certain claims. The group has also highlighted business relationships between some in the top echelon of the FDA and manufacturers. It even questions the FDA’s failure to recall the birth control device after the February 2016 announcement of a required black box warning and more safety studies saying that such action puts “a whole new group of unsuspecting women on a path to being harmed by the device with absolutely no legal recourse.”

A study published in the British Medical Journal suggests that Essure side effects put users at a 10-fold risk of surgical treatment compared to laparoscopic sterilization. In the United States, thousands of women affected by complications linked to the contraceptive are considering the filing of a product liability claim.

Contact our Essure injury lawyer or call on 1-800-632-1404 for an evaluation of your product liability claim.

FDA Mandates Black Box Warning To Highlight Essure Side Effects

essure attorney

The U.S. Food and Drug Administration, under pressure from activists and women who suffered from Essure side effects, has finally asked manufacturer Bayer to add a “black box warning” to its controversial birth control device. The step was imminent in the face of large number of adverse events reported in print and social media over the years. A joint Essure lawsuit representing two dozen women has also been filed against Bayer for “actively withholding” information on the contraceptive side effects reported to it.

According to the FDA statement posted on its website, the strongest safety warning label on Essure birth control is “to call attention to serious or life-threatening risks.” It also called for additional studies and trials to address Essure safety concerns. Essure was approved in November 2002 as a permanent sterilization option for women. By May 2015, the FDA received over 5,000 Essure side effect complaints highlighting contraceptive failure, migration, unintended pregnancies, abdominal inflammation and pain, uterus and fallopian tube perforation, severe allergic reaction, and miscarriages. Bayer is accused of hiding thousands of post-marketing reports on the birth control adverse events.

Essure device comprises of two nickel-titanium coils with tiny and flexible polyethylene terephthalate inserts. The coil when inserted into the fallopian tubes using a catheter induces scar tissue growth for a three-month period. This ingrowth turns into a barrier inside the fallopian tubes blocking sperm movement. It is a permanent sterilization method and for those who do not want children in the future.

The FDA Essure warning also accompanies a checklist for doctors to ask patients about their experience and provide inputs about safety and effectiveness of the birth control device. Planed to have a sample of size of at least 2,000, the assessment will go on for three years.

Earlier in July 2015, the FDA went for a review of the birth control. However, it ended with the manufacturer being asked to carry on more safety research. Consumer groups and activists are critical of such FDA action and have been demanding a recall of the birth control device. Bayer is also accused of not reporting Essure side effects to the FDA over the years and this could have led to safety assessment years earlier saving thousands of users.

Essure Perforation Lawsuit

A Texas woman has filed an Essure lawsuit claiming that side effects forced her to undergo hysterectomy surgery. She had severe pain, chronic cervical inflammation, and bleeding soon after she had the birth control device. The contraceptive side effects also resulted in fatigue and uneasiness during intercourse and she also developed ovarian cysts, according to the Essure injury lawyer representing her. She had to undergo a total hysterectomy to take out the contraceptive coil.

The Essure lawsuit claims that the plaintiff selected the birth control device, as the manufacturer failed to provide adequate information about potential adverse events linked to the contraceptive. Bayer has been accused of suppressing side effect complaints and misleadingly advertising the birth control coil as a safer sterilization procedure despite post-marketing reports on adverse events.

In February 2016, the FDA acknowledged at least 294 confirmed fetal deaths linked to Essure migration causing unwanted pregnancies. The figures, previously put at 125, were reviewed after the regulator found discrepancies in Bayer’s reporting of Essure adverse events. While thousands have become members of a Facebook group “Essure Problems” to express their anguish over sufferings due to the birth control side effects.

For filing Essure injury lawsuit seeking compensation and damages for complications associated with the Essure birth control device, contact our Essure attorney or call on 1-800-632-1404.

Essure Injury Lawsuits Continue To Rise

essure attorney

Over a million women in America use Essure permanent birth control system to prevent pregnancy. Unfortunately, thousands of women have filed an Essure injury lawsuit against Bayer, alleging that the device, claimed to be 100% effective by the manufacturer, has injured them. The plaintiffs demand monetary compensation from Bayer for the pain & suffering and a complete ban on the defective device.

What is Essure?

Essure is a contraceptive device that consists of two implantable metal coils inserted into a woman’s fallopian tubes via a catheter. Promoted by Bayer as the next generation of contraception, the device allegedly fails and migrates from its position in the woman’s body, causing a range of Essure side effects, including headaches, pain, hemorrhage, weight fluctuations, and menstrual irregularities.

Questioning the device’s safety, some plaintiffs have also complained of nickel allergy. Some women even have had to undergo hysterectomy to remove the metal coils from their fallopian tubes.

Essure Side Effects

Essure injury lawsuits accuse Bayer of misleading users with the warning labels that say possible side effects include: “mild to moderate pain and/or cramping, vaginal bleeding, and pelvic or back discomfort for a few days.” Plaintiffs claim that they have experienced severe nausea, fainting, and/or vomiting. Other symptoms of a complication include:

  • Excruciating, debilitating pain
  • Memory loss
  • Bleeding
  • Foggy head
  • Weight explosion
  • Perforated organs
  • Exhaustion
  • Fetal disfiguration from nickel poisoning
  • Bouts of depression
  • Metal coils lodged in colon
  • Suicidal thoughts

Not only patients but also doctors are coming forward to question the Essure birth control system’s effectiveness and safety for women, claiming that the device is at the root of many problems for their patients. Moreover, doctors find that since the device is fragile, physical removal of the coils is a difficult procedure. Some women have even reported injuries and adverse events from the disintegration of the device in their bodies, causing metal pieces to be scattered in different parts. Only a total hysterectomy can ensure complete removal of these foreign objects from the body, which is a costly and painful procedure.

Many complainants assert that some doctors recommend abortion and cannot remove the coils if a woman becomes pregnant, as they aren’t sure what to do next in such situations. This complicates problems for the patient, who had gone for the contraceptive procedure to prevent pregnancy. In such cases, the device not only failed to prevent pregnancy, but also caused severe Essure injuries and complications, such as nickel leaching in the body and the device migrating to and perforating the sac. Additionally, this puts the fetus at risk of nickel poisoning and disfigurement from the device’s movement. There is almost 55% risk of miscarriage in such cases.

Essure Injury Lawsuits

Accusing Bayer of negligence and neglect, plaintiffs claim compensation from the manufacturer for medical bills, pain, suffering and trauma, and loss of quality life. Essure lawsuits allege that Bayer’s negligence in promoting a defective product has left their life in misery and brought immense pain & suffering in their lives. They seek compensation for product liability, fraud, defective product, violation of implied & express warranty, failure to warn potential users of health risks, misrepresenting the device safety, willfully concealing Essure side effects, and improperly training doctors on using and removing the device if it goes wrong.

Contact our Essure injury attorney or call on 1-800-632-1404 to explore options for filing Essure injury lawsuit and seek compensation and damages for suffering from complications associated with the birth control device.

Essure Lawsuit Sues Bayer for Hiding Information About Birth Control Safety, Efficacy

essure attorney

Twenty-four women have come together to file a joint Essure lawsuit citing deception by manufacturer Pfizer in reporting side effects associated with the birth control. The litigation follows a report claiming that Bayer did not report about two-thirds of adverse events linked to the contraceptive to the FDA. Consumer groups, women activists, and other grassroots movements continue to urge the regulator to withdraw Essure birth control device citing perforation injuries and inability of the device to check unwanted pregnancy.

According to the Essure lawsuit filed in a Pennsylvania district court, the failure of Bayer to report unwanted pregnancy, uterus problems, and other risks of Essure side effects led plaintiffs to believe that the birth control was a safer alternative. However, these women experienced painful and debilitating Essure injuries, including fetal deaths, uterus perforations, unwanted pregnancies, and hysterectomies. Their Essure attorney argues that the manufacturer purposefully withheld and did not report “adverse events submitted by women nationwide” to conceal design defects in the birth control coil and further its commercial gains.

The Essure lawsuit pointed out 2013 FDA finding of 16,000 complaints involving the contraceptive on an internal document that was never reached the regulator. A large number of these adverse events highlight migration of the birth control device outside the fallopian tube. Details submitted by the concerned Essure attorney also showcase that though Bayer was aware of at least 144 uterus perforation incidents, only 22 found their way to the FDA. No adverse events involving the contraceptive migration or breaking down was ever reported. Making the matters worse, the manufacturer made no assessment of the quality, safety, or Essure side effects. It defended the non-reporting saying that these are “mere trial damage that does not rise to the level of a serious injury” and most complainants did not experience long-term pain.

An independent analyst has gone a step further and claimed that Bayer “mislabeled” 300 side effect incidents reported to it between August 2015 and February 2016 to keep them concealed. All these Essure injury reports were categorized as “filed by others” instead of medical practitioners to avoid their reporting to the FDA. In March, the federal regulator announced a “black box warning” on Essure contraceptive device to highlight “serious or life-threatening risks.”

Essure Side Effects

The recent surge in the filing of Essure lawsuits across the United States indicate that extent of injuries linked to the birth control device. Between November 2002 and May last year, at least 5,000 Essure injury complaints were reported directly by users through the MedWatch. These figures exclude thousands of adverse events the manufacturer informed of.

The most reported Essure side effects are:

  • Contraceptive migration
  • Uterus perforation
  • Birth control coil breaking down into pieces
  • Damage to reproductive organs
  • Unwanted pregnancy
  • Nickel poisoning
  • Abdominal pain and cramping
  • Vaginal bleeding
  • Pelvic pain and inflammation
  • Neurological side effects, such as fainting, memory loss, depression, foggy head
  • Hot flashes
  • Hair loss
  • Design defect cause incorrect placement

Essure birth control has also been linked to fetal death traced to nickel poisoning and leaching. The chemical coating on the device releases toxic elements and this causes scar tissue formation, inflammation, and other complications, including postnatal mortality in case of unwanted pregnancy following the implant migration. The lack of training for inserting the complex birth control coil puts users at the risk of device migration and reproductive organ perforation. Those with perforated uterus and fallopian tubes have the greater chance of miscarriage when they conceive unknowingly after Essure migration.

Contact our Essure attorney or call on 1-800-632-1404 to explore options for filing Essure injury lawsuit seeking compensation and damages for suffering from complications associated with the birth control device.

Congress Members Join Demand To Recall Essure Birth Control Device

Essure lawyer

Mounting number of Essure lawsuit claims and reports citing thousands of injury and death incidents linked to the birth control device have led to increasing demand for its market withdrawal. In a show of support, the members of the Congress have written to the FDA to consider revoking the approval given to Essure birth control. MedWatch reports cite over 5,000 Essure injuries, including abdominal pain, menstrual disorders, internal organ injuries, infection, bleeding, fallopian tube perforation and death. In 2012, there were about 100 Essure injury complaints. Two years later, the complaints grew 20 fold to reach 2,259. More than 23,000 “women who had the Essure procedure done, and are suffering or have suffered from side effects which may be attributed to Essure” are members of a Facebook group called Essure Problems.

Congress To Facilitate Essure Birth Control Recall

Amid hundreds of potential Essure lawsuit claims being evaluated by Essure attorneys nationwide, Penn State Representative Mike Fitzpatrick has announced his intention of introducing a bill in the Congress to facilitate recall of the transvaginal contraceptive from the US market. The bipartisan bill includes provisions seeking “revocation of the pre-market approval given by FDA to Essure’s original developer, Conceptus, in 2002.” This will force Bayer to withdraw Essure.

The proposed bill is supported by Connecticut Congresswoman Rosa DeLauro, a vocal critic of the contraceptive device and at the forefront of demand to recall Essure transvaginal device. She wrote to the FDA in October 2015 citing “a citizen petition filed on behalf of hundreds of women injured by Essure” urged “the FDA to take immediate action and remove the device from the market.”

DeLauro also asked the agency a number of pointed questions about how the hearing was conducted, seeking information on why a panel of women who had actually participated in the Essure clinical trials were not allowed to report to the panel. Had they been allowed, according to DeLauro, their public testimony would have indicated that Essure’s sponsors changed patient ages and information on the Essure complications they suffered when they submitted the data to the FDA for approval.

DeLauro also noted that independent experts were not given sufficient time, and that the FDA has only posted 11 out of more than three thousand comments submitted to the docket of the citizen’s petition calling for an Essure recall.

“Essure’s benefits do not outweigh its risks, and it should be withdrawn from the market,” DeLauro said. “If well-designed studies in the future indicate that the benefits outweigh the risks compared to alternative permanent or long-term contraception, the FDA can consider approving Essure at that time.”

Her letter came in support of consumer groups calling for withdrawal of the FDA approval to the contraceptive citing increasing number of lawsuits claiming Essure injuries. In 2014, a Congressional hearing on the transvaginal device demanded change to FDA approval process so as to facilitate filing of product liability lawsuit against medical device makers.

FDA Panel Recommends More Safety Research

The FDA Obstetrics and Gynecology Devices Advisory Panel, which met on September 24, also recommended more research on Essure safety data. The first such meeting on the contraceptive in 13 years of its approval, it was attended by over two dozens of women subject to Essure side effect injuries. All victims strongly demanded the withdrawal of the product. Their disposition forced the panel members to express concern over inadequate safety data related to the birth control device and question the manufacturer about shortcomings during clinical trials. A FDA report published prior to the panel meet acknowledged the existence of “very little reliable post-marketing data by independent researchers to support whether Essure is working in the real world, as it did in pre-market clinical trials.”

Hundreds of Essure lawsuit claims by women are being evaluated by lawyers across the United States for potential product liability damages. A number of cases have already been filed seeking compensations. Contact our Essure injury attorney or call on 1-800-632-1404 to explore options for filing Essure injury lawsuits and seek compensation and damages for suffering from complications associated with the birth control device.

 

Essure Attorney Reports on Study Results

Essure Attorney

As an Essure Attorney, I wanted to spend a minute posting on some research studies on the Essure device for our readers.

In April 2015, the Journal of Minimally Invasive Gynecology published a long-term monitoring report based on larger trials involving Essuer birth control device. The data, though, pertains to monitoring of volunteers between 2002 and 2007, it was not published eight years. Of 518 volunteers, only 366 were monitored for full five years. Among them, 38 percent suffered from menstrual bleedings, 5 percent experienced pelvic pain, about 7 percent had painful menstruation, and 4 percent complained of pain during sex. Fifteen women had hysterectomies.

The FDA has received at least 5,000 Essure injury complaints, including four deaths and dozens of fallopian tube or uterus perforation reports. A citizens’ petition presented to the regulator, highlights 16,047 adverse events associated with the transcervical birth control device reported to Conceptus, the original manufacturer and now part of Bayer, between 2011 and 2013.

A Florida woman, through her Essure attorney, has sued Bayer citing negligence and misrepresentation. Five more lawsuits are pending in a Pennsylvania federal court claiming that manufacturers “breached warranty and committed fraud during the clinical trials to get the device approved by the FDA.”

Contact our Essure injury attorney or call on 1-800-632-1404 to explore options for filing Essure injury lawsuits and seek compensation and damages for suffering from complications associated with the birth control device.

Essure Injury: Expect Many Injury Lawsuits To Be Filed

Essure Attorney

 

The fear of Essure injury was not even in the slightest imagination of Angie Firmalino when she had the birth control device implanted in 2009. Like many, the mother of four believed in the promotion of the transcervical device as a breakthrough sterilization option completed in just 10 minutes. However, the results were something unexpected and now 42, the New York mother shivers to recollect her painful experience.

After having the Essure birth control, Angie suffered from severe pain and bleeding for two years. Diagnosis revealed that the transcervical birth control had broken apart and embedded in her uterus. The injury and complications forced her to undergo multiple surgeries, including surgical removal of the uterus.

“If I had any idea of the possible consequences of Essure, I would never have chosen it,” says Angie, who now has to take daily dosages of ibuprofen to prevent the pain from impacting her activities. She now runs a Facebook page “Essure Problems” that has more than 19,900 members and become a popular medium of “posting pictures and sharing nightmare stories about Essure side-effects.”

Essure, a metal and polyester coil, is inserted into the fallopian tubes through the vagina. Made of “polyethylene terephthalate and nickel titanium alloy,” the coil causes inflammation and formation of scar tissues that block the entry of sperms to the fallopian tube. It had a fast-track FDA approval in 2002. However, the horrific stories of injuries after 13 years put a serious question on its safety aspects.

Trial Data Reveals Essure Injury Risk

Essure injury side effects were found during the early in clinical trials. A Cleveland woman, one of the volunteers selected for human trial, filed an Essure lawsuit seeking $1 million in damages. The plaintiff suffered from hip and joint pain, fatigue, migraine, and painful menstrual periods after using the birth control device. Another volunteer had surgery to stop menstrual bleeding.

The Human Reproduction journal reported in 2003 that nine of about 250 women suffered of fallopian tube perforation and a few others had device migration issues during a safety trial. One in every 10 complained of pain during sexual intercourse. Eight volunteers reported painful menstrual periods.

In another trial, 21 of 449 volunteers suffered from reproductive organ perforation. Surgeries performed on eight to remove the displaced device. Many other had abdominal pain and painful sexual intercourse. In 2002, the FDA approved Essure on the condition that “investigators monitor volunteers for four years.” However, only 171 women were monitored for five years and others were abandoned after the first two years.

A report by the FDA acknowledges that at least five women volunteers underwent hysterectomies after the birth control trial while 270 had adverse events, including painful menstrual.

Contact our Essure injury attorney or call on 1-800-632-1404 to explore options for filing Essure injury lawsuits and seek compensation and damages for suffering from complications associated with the birth control device.

 

Essure Injury Lawsuit Seeks $1 Million Damage, FDA Panel To Review Risks

Essure Injury Lawsuit

Forty-three-old Cleveland resident Kim Hudak has filed an Essure injury lawsuit seeking $1 million from birth control device manufacturer Bayer. She suffered pain and other injury symptoms and had to undergo multiple surgeries necessitated by injuries associated with the contraceptive. In 2000, at the age of 28, she volunteered to receive the transcervical implant during an early human trial by the manufacturer.

Mrs Hudak’s Essure attorney claims that she had “sharp pain in her right hip” soon after she was implanted with Essure birth control device. While the pain continued despite treatment, she had very painful menstrual periods, migraine, joint pain, flu-like symptoms and incessant fatigue that sapped her ability to work. Her Essure lawsuit has sought $1 million in compensation against Bayer for injuries and lost wages.

FDA Probe Ordered Over Essure

Continuing complaints and initiation of litigations over Essure injury, the FDA has announced to review the risks and safety concerns associated with the birth control device. The Obstetrics and Gynecology Devices Advisory Panel is expected to meet and discuss the need for regulatory action on September 24. Meanwhile, women and consumer groups have begun proceedings in the court and outside to seek the accountability of the manufacturer for Essure injury incidents.

FDA allowed Essure birth control in 2002 after a fast-track approval process. Touted as a long-term birth control, the device is implanted in an outpatient procedure. However, the insertion of the transcervical device itself poses serious risks. The coil-shaped device is inserted into “the fallopian tubes, passing through the vagina, cervix and uterus,” which may result in scar tissue formation and consequent blockage of tubes that obstructs insemination.

Thousands of complaints made in the last four years have already forced the federal drug regulator to issue an alert updating Essure injury risks on the product label. It warned of long-term risks, such as

  • Essure migration to lower abdomen and pelvic area
  • Essure uterus perforation
  • Pelvic pain and inflammation
  • Ectopic pregnancy
  • Nickel allergy

The FDA has acknowledged of receiving at least 5,093 adverse event reports directly while at least 10 time of that number are expected to have been victims of Essure side effects. Over 18,000 women have joined a social media group on Facebook to share stories on Essure complications. An analysis of MedWatch reports reveals that at least four women died due to Essure injury while 1,408 had menstrual irregularities. Extreme abdominal pain, strap infection, fatigue, headache, bleeding, and internal organ injuries are also frequent.

Essure Injury Leads To More Lawsuits

Consumer groups and citizens demanded revocation of premedical approval and recall of the Essure birth control device in January 2015 citing damaging complications and side effects. Activists, such as Erin Brockovich joined the demand after thousands of women used Facebook to vent their stories related to Essure complications. A summer 2014 Congressional hearing over an Essure injury called for an overhaul of FDA approval process that manufacturer cite to claim immunity from litigations.

The first Essure lawsuit was initiated by a Florida woman. Filed in a Philadelphia court, the lawsuit claims “negligence and breach of express warranties” by manufacturer Bayer citing injuries during the birth control device implant. In April 2015, a woman died, as implant led to uterus puncture and bleeding.

Five more litigations followed the first one highlighting serious injuries, including Essure uterus perforation, and alleging that “Conceptus, the original manufacturer now acquired by Bayer, breached its warranty and committed fraud in the clinical trials to get the device approved by the FDA.” Essure attorneys representing the plaintiffs in an Eastern District Court of Pennsylvania also claim that “FDA premarket approval for Essure is invalid, as the manufacturer failed to report adverse events associated with the birth control devices and this removes protection from product liability.” Hundreds others are expected to join the litigation in the coming months.

Contact our Essure injury attorney or call on 1-800-632-1404 to explore options for filing Essure injury lawsuits and claim compensation and damages for suffering from complications associated with the birth control device.