FDA Imposes Essure Restrictions Due to Health Issues

By Andrew Emett

Due to the health risks associated with the Essure birth control device, the U.S. Food and Drug Administration (FDA) recently issued an order restricting the sale and distribution of the device. Despite the fact that Bayer has announced discontinuing sales of Essure across the world, the U.S. remains the only country where the device is marketed and sold.

On April 9, the FDA ordered changes to the Premarket Approval (PMA) of Bayer’s Essure sterilization procedure, requiring doctors and patients to sign off on a checklist of potential health problems, to ensure that the patient is fully informed about the risks. Although there has been an approximately 70 percent decline in sales of Essure in the U.S. within the past few years, the FDA has determined that some women still are not receiving information about the known risks of Essure before implantation.

“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” said FDA Commissioner Scott Gottlieb. “We take the concerns of all women affected by Essure very seriously. I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”

Inserted into the fallopian tubes via catheterization, the Essure implant is intended to be a permanent birth control device that prevents conception by building a layer of scar tissue around the implant. Major complications associated with Essure include pain, hemorrhages, severe cramping, blood clots, infection, unintended pregnancy, migration of device, and device breakage.

Besides migrating to other parts of the body and causing organ perforation, Essure devices can also lead to other adverse effects, including excessive bleeding, pelvic pain, ectopic pregnancy, and an allergic reaction to nickel in the coiled implant. Complications with Essure devices have resulted in hysterectomies, salpingectomies, and death.

“Ensuring informed decision making is just one important step in our ongoing efforts to monitor this device. We remain committed to carefully and thoroughly considering all new data and evidence and will continue to work with patients affected by this device as part of our process,” said Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health. “While some women may continue to choose Essure as their birth control option based on current information, as new information becomes available, the FDA will continue to keep the public informed of the agency’s evaluation and findings, and consider regulatory options that appropriately balance benefits and risks for Essure.”

According to Gottlieb, the FDA received nearly 12,000 adverse event reports related to Essure last year with the majority of the reports sent in the last quarter of 2017. More than 90 percent of the reports last year mentioned issues involving potential device removal, which the FDA is further investigating.

The FDA is currently waiting for Bayer to finish a safety study involving thousands of women and designed to examine the hazardous side effects of Essure coils. Although the FDA has seen an increase in the total number of enrolled patients over the past six months, the study is not scheduled for completion until 2023.

NJ Jury Slams J&J with Historic $80M Punitive Damages Talc Verdict

 By Emily Cox
Flickr/Austin Kirk

A New Jersey state jury hit Johnson & Johnson (J&J) and its talc supplier with $80 million in punitive damages on Wednesday after ruling that the healthcare behemoth knowingly sold asbestos-contaminated talcum powder despite significant mesothelioma and cancer risks, demonstrating a blatant disregard for consumer health and a corporate culture rooted solely in avarice.

The Middlesex, New Jersey talc trial began in January 2018. During the trial, plaintiffs Stephen Lanzo III and his wife alleged that Lanzo was exposed to asbestos from J&J’s flagship Baby Powder from infancy through 2003. Lanzo testified that he used two to three large bottles of the talc powder per month. As a result of his talc use, he received a terminal mesothelioma diagnosis in 2016.

Lanzo’s victory over the global conglomerate may open a new front in the ongoing talcum powder litigation against J&J. This is J&J’s first loss over mesothelioma claims.  Most asbestos cases to date have contended that &J intentionally added asbestos to its talc. In a departure from this decidedly unsuccessful strategy, Lanzo argued that asbestos occurred naturally in the company’s talc. Materials science expert William Longo testified that he tested 32 samples of factory-sealed containers of J&J’s baby powder from over the decades. Longo identified asbestos fibers in 18 of the 32 samples.

Talc Punitive Damages Verdict

The punitive damages verdict comes nearly a week after the jurors handed down a $37 million  compensatory damages verdict against J&J and Imerys Talc. Subsequently, they found that the companies’ wanton and willful indifference to the rights and safety of its consumers warranted additional punitive damages. Consequently, the jury levied $55 million in punitive damages against J&J and $25 million against Imerys.

During closing arguments for the punitive damages phase of the trial, Lanzo’s attorney urged jurors to send an strong message to these companies to stop selling baby powder that contains talc and discourage future misconduct.

“Your voice should be loud. It should be so loud that all the arguments that they make cannot drown out your voice. They should not be heard to tell you that you’re wrong,” Lanzo’s lawyer said. “They should not be heard to say we hear you, but nothing changes.”

After the jury returned with its punitive damages verdict Wednesday, Lanzo’s attorney proclaimed that it was “a historic verdict.”

“Over 50 years ago, the events that led to Steve Lanzo getting mesothelioma started. They knew they had asbestos in their products and every one of the documents that we entered into evidence in this case was marked…  protected, confidential, secret,” Lanzo’s lawyer said.

“It is really one of the greatest things that [we] have ever done in our careers was to enter these documents into evidence to let the public know, to let people know of the risks and the harms that they were facing,” he added.

Ongoing Talc Litigation

J&J is still facing more than 6,600 lawsuits over concealing its Baby Powder’s considerable risks. The majority of these cases relate to ovarian cancer claims from J&J’s Baby Powder and Shower-to-Shower talc product lines. Overwhelmingly, juries have found for the women in these cases and levied extraordinary punitive damages verdicts. Now, it appears that the faltering mesothelioma litigation may have finally found its stride.


Heartburn Medication Lawsuits Over Kidney Damage Number in the Thousands

By Emily Cox
Heartburn Medication
Flickr/Rennett Stowe

The heartburn medication litigation continues to gain momentum and won’t be slowing down anytime soon. A new status report in the fledgling multidistrict litigation (MDL) indicates that there are already more than 2,000 heartburn medication lawsuits against various proton pump inhibitor (PPI) manufacturers over serious kidney damage from medicine cabinet staples such as Nexium and Prilosec.

Due to the widespread use of these drugs, experts believe that the currently pending lawsuits are only the tip of the idiomatic iceberg. They are projecting explosive growth in the MDL’s size and scope in the weeks to come.

The litigation reverberates with claims that PPI manufactures consciously put patients at considerable risk in the name of the almighty dollar. Plaintiffs allege that these companies actively concealed substantial health risks from consumers and the medical community, protecting profits before patients. Consequently, many users developed substantial kidney injuries, chronic kidney disease, and renal failure among other serious complications. However, despite overwhelming evidence supporting the link between PPI use and kidney damage, these companies continue to safeguard their own financial health at the cost of consumers’ lives.

Heartburn Medication MDL Prepares for Rapid Expansion

Due to the inherent similarities in claims throughout the federal court system, the Judicial Panel on Multidistrict Litigation (JPML) centralized all U.S. District Court cases in August 2017 to optimize judicial efficiency. The JPML consolidated these lawsuits in the District of New Jersey, coordinating pretrial proceedings and discovery before U.S. District Judge Claire C. Cecchi.

Judge Cecchi spoke with litigation lawyers Tuesday to discuss various aspects of the MDL as it continues to move forward, including the size and scope of the litigation. Parties filed a joint status report this past week in preparation for the status conference. The report indicates that there are at least 1,929 cases pending before Judge Cecchi. These involve 1,963 different individuals, as well as around 100 state-level cases nationwide.

The status conference further addressed a recent proposal to temporarily bundle up to 300 plaintiffs into one lawsuit. Parties also reviewed the status of the defense fact sheet, discovery search terms proposal, status of depositions, and scheduling orders, as well as the prospect of a “Science Day.”  The determinations of this conference call should be released in the next couple of days.

As the two-year anniversary of the release of vital heartburn medication studies draws near, the Court expects a large influx of additional plaintiffs to come forward in the next coming weeks. Consequently, the size and scope of the MDL could double or tripe by the end of 2018.

Heartburn Medication Kidney Injury Lawsuits

Several studies suggest that PPI users may face serious kidney damage. Researchers indicate that these popular drugs may cause acute kidney injury, chronic kidney disease, and end-stage kidney failure. These conditions often result in the need for dialysis treatment or a kidney transplant.

In February 2016, JAMA Internal Medicine published a study indicating that Nexium, Prilosec, and other PPIs increased chronic kidney disease risks by up to 50 percent. Department of Veterans Affairs’ researchers supported these findings in a landmark April 2016 study. They found that heartburn medication users could be 96 percent more likely to suffer from kidney failure. Users were also 28 percent more likely to develop chronic kidney disease after five years of use.

Despite compelling evidence that these companies were aware of these risks, they are conspicuously absent from popular heartburn drug warning labels. Consequently, millions of Americans are oblivious to the potential for devastating consequences and continue to use these drugs daily. The FDA did not address PPI kidney damage until these drugs had been on the market for almost three decades.

The FDA finally mandated new warnings about PPI kidney risks in December 2014. The agency required labeling to reflect the risk for acute interstitial nephritis (AIN) from the use of these heartburn drugs. AIN involves the sudden inflammation of the kidneys and can set an irreversible course for further kidney problems and failure.

J & J and Imerys Talc Ordered to Pay $37M in Mesothelioma Lawsuit

By Andrew Emett

Johnson & Johnson and its talc powder supplier, Imerys Talc America Inc., were ordered to pay $37 million in compensatory damages on Thursday to a man who developed mesothelioma after using the company’s asbestos-laced talcum powder for decades. The jurors are scheduled to return on Tuesday to determine the punitive damages in the trial.

After using J & J’s Baby Powder for years, Stephen Lanzo III was diagnosed with mesothelioma nearly two years ago. Unbeknownst to Lanzo, J & J’s talc powder contained the asbestos which resulted in his medical condition.

According to Lanzo’s attorney, Moshe Maimon of Levy Konigsberg LLP, the company’s talcum powder contained asbestos for years, but executives hid that fact from consumers and regulators by utilizing tests that they knew wouldn’t detect the toxic mineral. Maimon told jurors during his closing argument, “They came up with the method that was never going to find the asbestos that was there, so they could certify that they looked and never found it.”

An executive’s internal memo from 1973 revealed that there was a definitive amount of asbestos in J & J’s flagship product. The executive concluded that the exposure was less than acceptable amount allotted for an asbestos minor. Yet, J & J markets this product for babies.

With the trial lasting longer than two months, a New Jersey state jury awarded compensatory damages of $30 million to Lanzo and $7 million to his wife, Kendra, on Thursday while holding J & J responsible for 70 percent of the damages and Imerys responsible for 30 percent. Jurors were instructed by Superior Court Judge Ana Viscomi to return on Tuesday to determine the punitive damages in the case.

Bard Ordered to Pay Injured Woman $1.6M in IVC Bellwether Trial

By Andrew Emett

A federal jury ordered Bard to pay nearly $2 million in compensatory damages on Friday to a woman whose inferior vena cava (IVC) filter broke apart inside her body. Found responsible for 80 percent of the harm, Bard may also be liable for punitive damages.

Bard IVC filters, including Recovery and G2 filters, are implanted in patients who are immobilized or who are not able to take anticoagulant medications. They help to filter the blood, preventing blood clots from moving through the body and causing a pulmonary embolism.

These devices are cone-shaped, with legs that extend to intercept and trap blood clots. Candidates for implantation with Bard IVC filters have a history of blood clots, deep vein thrombosis, trauma, immobilization, or have recently had surgery.

To prevent blood clots from forming, Sherri Booker had a Bard G2 filter implanted at the age of 37. The device later broke apart inside her inferior vena cava, and she required open-heart surgery in 2014 to retrieve the filter pieces.

Despite the fact that Bard argued the heart surgeon was a cause of injury to Booker, the jury disagreed with the medical manufacturer. According to the nine-member jury, Bard was responsible for 80 percent of the harm done to Booker, while a radiologist who failed to flag a visibly separated filter piece on an X-ray in 2009 was responsible for 20 percent of the blame.

Under U.S. District Judge David Campbell, the multidistrict litigation (MDL) includes more than 3,600 plaintiffs. Following Friday’s verdict, the punitive damages phase of the first bellwether over the IVC device will immediately follow.

AbbVie Ordered to Pay $3.2M in AndroGel Retrial

By Andrew Emett

A federal jury recently ordered AbbVie to pay $3.2 million to an Oregon man who suffered a heart attack while using the testosterone replacement drug AndroGel. Although the jury did not find AbbVie strictly liable, they found that the drug manufacturer acted negligently by withholding information from consumers and doctors about the potential side effects of AndroGel.

After nearly five years of treatment with AndroGel, Jesse Mitchell suffered a heart attack in 2012. Mitchell took several months to recover and filed a lawsuit against AbbVie for negligence and falsely marketing the drug.

In July 2017, the jury determined that AbbVie was not negligent or strictly liable for Mitchell’s heart attack but concluded that the company falsely marketed the drug. The jury awarded Mitchell $150 million in punitive damages even though it did not award him any compensatory damages.

In December 2017, U.S. District Judge Matthew Kennelly ruled that the jury’s findings were “logically incompatible” and overturned the $150 million verdict. Kennelly wrote, “The irreconcilable conflict between the jury’s finding of liability on the fraudulent misrepresentation claim and award of zero compensatory damages requires a new trial on this claim.”

On Monday, a new jury awarded Mitchell $3 million in punitive damages and $200,000 in compensatory damages. Despite the fact that the federal jury found AbbVie had acted negligently, the company was cleared on strict liability and fraudulent misrepresentation claims.

In October 2017, a separate jury ordered AbbVie to pay $140 million in punitive damages, and $140,000 in compensatory damages to a Tennessee man who suffered a heart attack while using AndroGel. AbbVie has also asked Judge Kennelly to throw out that verdict over inconsistencies during the trial.

More than 4,000 cases are currently pending against AbbVie. In recent months, several other manufacturers of testosterone replacement therapy drugs, including GlaxoSmithKline, Eli Lilly & Co., Auxilium, and Endo International, have agreed to settle hundreds of lawsuits against them. The terms of those suits have not been disclosed.

J & J Failed to Warn About Invokana Amputation Risks

By Andrew Emett

Accused of failing to provide adequate warning labels about the potential side effects of Invokana, Johnson & Johnson was recently named in a lawsuit filed by a man from New York who required a partial leg amputation after taking the medication. Although the pharmaceutical company aggressively marketed the drug to doctors and diabetic patients, J & J also sold it for off-label purposes, including weight loss and reduced blood pressure.

In March 2013, the U.S. Food and Drug Administration (FDA) approved canagliflozin (Invokana) for the treatment of type 2 diabetes. While Invokana remains the largest seller, other members of this class include Invokamet, Jardiance, and Farxiga.

In January 2014, John Krause was prescribed Invokana for treatment of type 2 diabetes. After taking the drug for two years, he was diagnosed with severe sepsis and required a left guillotine amputation on February 5, 2017, followed by a left femoral below knee amputation on February 7, 2017.

On March 16, Krause filed a complaint in the U.S. District Court for the District of New Jersey against J & J and its Janssen Pharmaceuticals subsidiary for failing to properly disclose the adverse potential side effects of Invokana for several years. According to the lawsuit, the defendants have paid at least $27 million to approximately 69,000 doctors in an effort to aggressively promote the drug.

“Consumers of Invokana and their physicians relied on the Defendants’ false representations and were misled as to the drug’s safety, and as a result have suffered injuries including diabetic ketoacidosis, kidney failure, sepsis, cardiovascular problems, stroke, amputations and the life-threatening complications thereof, “Krause’s lawsuit states. “Plaintiff had several alternative and safer methods to treat his diabetes, including diet, exercise and other diabetes medications.”

The lawsuit also notes, “In December 2015, the FDA required Defendants to change the Invokana warning label to warn of ketoacidosis and urosepsis – a severe, life-threatening bacterial infection of the blood which can injure the kidneys.

“In June 2016, the Invokana warning label was changed to include kidney failure warning.

“In August 2016, the Invokana warning label was changed to include reports of ‘fatal’ diabetic ketoacidosis.

“In February 2017, the Invokana warning label was changed to include more detailed warnings on diabetic ketoacidosis and acute kidney injury.

“In May 2017, the FDA issued a Drug Safety Communication indicating there was evidence of a casual relationship between Invokana and an increased risk of amputations.”

According to the FDA, amputations of the toe and middle of the foot are the most common in Invokana amputation cases. However, amputations involving the leg, below and above the knee, also occur. Some patients had more than one amputation, including both legs.

Krause’s lawsuit will be consolidated with other Invokana lawsuits pending in the federal court system. Bellwether trials are expected to begin in order to help gauge how future juries may respond to allegations that manufacturers failed to disclose the drug’s substantial risks.

Facebook Users and Investors File Class Action Lawsuits over Data-Sharing Scandal

By Andrew Emett

In response to recent disclosures of Cambridge Analytica collecting the personal data of 50 million Facebook users without their knowledge or consent, at least two class action lawsuits have been filed against Facebook for allowing the breach to occur and failing to take any action to protect its users for two years. In the investor class action lawsuit, Facebook CEO Mark Zuckerberg is named in the complaint for giving investors a false and misleading view of the company.

On March 17, Cambridge Analytica (CA) whistleblower Christopher Wylie told The Guardian that secretive U.S. hedge-fund billionaire and Republican donor, Robert Mercer, and former White House Chief Strategist Steve Bannon used the data mining company to access the personal information of 50 million Facebook users in order to deploy effective psychological warfare against them during the 2016 presidential election. By posting a survey app on Facebook called “MyDigitalLife,” CA accessed a backdoor allowing them to gather the personal data of the 270,000 people who downloaded the app along with the personal information of all their Facebook friends.

On March 20, Facebook user Lauren Price filed a complaint in the U.S. District Court for the Northern District of California against Facebook and Cambridge Analytica on behalf of herself and other similarly situated users. Facebook recently banned Cambridge Analytica from advertising on the website but had known about the breach for two years without taking any action.

“This case involves the absolute disregard with which the Defendants have chosen to treat Plaintiff’s Personal Information,” Price’s class action lawsuit states. “While this information was supposed to be protected, and used for only expressly disclosed and limited purposes, CA, without authorization, or by exceeding whatever limited authorization it, or its agents, had, improperly collected the Personal Information of nearly 50 million Facebook users. Facebook, for its part, knew this improper data aggregation was occurring and failed to stop it, or actively avoided discovering such knowledge in order to profess supposed ignorance.”

The complaint continues, “Facebook stored the Personal Information of Plaintiff and members of the Class in its electronic and consumer databases. Defendants represented to Plaintiff and members of the classes that their Personal Information would remain private. Defendants engaged in unfair acts and business practices by representing that they would not disclose this Personal Information without authorization, and/or by obtaining that Personal Information without authorization.

“Plaintiff and the Class members suffered injury in fact and lost money or property as the result of Defendants’ unfair business practices. In particular, Plaintiff and Class members’ Personal Information was taken and is in the hands of those who will use it for their own advantage, or is being sold for value, making it clear that the hacked information is of tangible value.”

On March 20, an investor class action lawsuit was filed by Fan Yuan in California’s Northern district against Facebook, CEO Mark Zuckerberg, and CFO David Wehner. Accusing Facebook of making “materially false and/or misleading” claims about the company’s handling of user data, the complaint pointed out that Zuckerberg knew about the breach for two years without disclosing information to investors who continue to lose money as shares of Facebook have dropped with the recent revelations.

On March 23, Elon Musk deleted the official Tesla and SpaceX pages from Facebook in protest against the company’s handling of the data breach.

Although Zuckerberg publicly apologized for failing to protect the personal data of his users, the Facebook CEO sold more than 1.14 million shares in the two weeks before the Cambridge Analytica reports became public. Cambridge Analytica CEO Alexander Nix was recently suspended after British investigative journalists secretly recorded him gloating about the company’s tactics using bribes, blackmail, and prostitutes to coerce politicians while boasting of CA’s work in the 2016 election on behalf of Donald Trump’s campaign.

Four Taxotere Hair Loss Lawsuits Selected for First Bellwether Trials

By Andrew Emett

With more than 5,600 product liability complaints pending against the manufacturers of Taxotere, four plaintiffs have been selected to proceed with the first bellwether trials scheduled to begin later this year. Arentz Law Group and co-counselors represent two of the four plaintiffs who will be participating in these bellwether trials.

“Although alopecia, or hair loss, is a common side effect related to chemotherapy drugs, permanent alopecia is not,” stated the complaint brought by Antoinette Durden. “Defendants, through their publications and marketing materials, misled Plaintiff, the public, and the medical community to believe that, as with other chemotherapy drugs that cause alopecia, patients’ hair would grow back.”

Introduced by Sanofi-Aventis in 1996, Taxotere (docetaxel) is chemotherapy drug that can result in permanent hair loss, including the crown, scalp, underarm hair, pubic hair, eyebrows, and eyelashes. According to the product information, side effects of Taxotere include “short term hair loss (in most cases normal hair growth should return).”

“Permanent baldness (permanent alopecia) is a disfiguring condition, especially for women,” Tanya Francis’ complaint noted. “Women who experienced disfiguring permanent alopecia as a result of the use of Taxotere suffer great mental anguish as well as economic damages, including, but not limited to, loss of work or inability to work due to significant psychological damage.”

On March 9, U.S. District Judge Kurt Engelhardt in the Eastern District of Louisiana identified the four cases proceeding to the second phase of discovery in a case management order. The selected bellwether cases include complaints brought by Antoinette Durden, Tanya Francis, Barbara Earnest, and Lisa Tuyes.

According to their complaints, Sanofi-Aventis had been aware of studies relating Taxotere to permanent hair loss and intentionally withheld reports of Taxotere patients suffering more than ten years of permanent alopecia. In 2009, the U.S. Food and Drug Administration (FDA) issued a warning letter to Sanofi-Aventis after falsely claiming that Taxotere was a superior alternative to existing low-potency taxanes, such as Taxol.

Due to Taxotere’s false marketing and inaccurate reports, the plaintiffs allege that the drug manufacturers knew or should have known about the issues with hair loss for years but decided to place profits above consumer health.

It has been estimated that up to 75% of breast cancer patients who have undergone chemotherapy have been prescribed Taxotere. Furthermore, research published by the National Cancer Research Institute found that 10-15% patients prescribed the medication suffered permanent hair loss.

The first bellwether trial is scheduled to begin on September 24.

FDA Reports Nearly 12,000 Problems with Essure in 2017

By Andrew Emett

The head of the U.S. Food and Drug Administration (FDA) recently announced that the agency received nearly 12,000 adverse event reports involving problems with Essure devices last year. Although sales of Essure have been discontinued across the world, the U.S. continues to sell the controversial birth control device.

On March 7, FDA Commissioner Scott Gottlieb issued a press release concerning post-market review of Essure while keeping women informed of the risks associated with the device, which is manufactured by Bayer. Major complications associated with Essure include pain, hemorrhages, severe cramping, blood clots, infection, unintended pregnancy, migration of device, and device breakage.

Besides migrating to other parts of the body and causing organ perforation, Essure devices can also lead to other adverse effects, including excessive bleeding, pelvic pain, ectopic pregnancy, and an allergic reaction to nickel in the coiled implant. Complications with Essure devices have resulted in hysterectomies, salpingectomies, and death.

“Some of the women I spoke to went on to develop significant medical problems that they ascribe to their use of the product,” Commissioner Gottlieb wrote. “As a physician, I know that patients are uniquely positioned to provide feedback to the FDA about their experiences with currently available medical products, and I appreciated the thoughtful discussion. Ensuring the safety and effectiveness of medical products is paramount to the FDA and a core part of our consumer protection role. The FDA takes concerns about Essure very seriously.”

Approved by the FDA on November 4, 2002, Essure was manufactured and marketed by Conceptus before Bayer acquired Conceptus in June 2013. Inserted into the fallopian tubes via catheterization, the Essure implant is intended to be a permanent birth control device that prevents conception by building a layer of scar tissue around the implant.

In 2016, the FDA decided not to recall Essure in the U.S. but required black box warning labels to be placed on boxes containing Essure implants. On September 18, 2017, Bayer issued a press release stating that the company was discontinuing sales of Essure in every country across the world, except in the U.S.

According to Gottlieb, the FDA received nearly 12,000 adverse event reports related to Essure last year with the majority of the reports sent in the last quarter of 2017. More than 90 percent of the reports last year mentioned issues involving potential device removal, which the FDA is further investigating.

“Most of this new information comes from cases that were made available by plaintiff attorneys as part of litigation against the product sponsor. We appreciate any opportunity to receive additional information about the safety of this product. We’re working to evaluate whether these cases reflect new safety concerns, as well as the extent to which they represent entirely new reports to the FDA or may have been reported in a prior safety filing.”

Approximately 750,000 women around the world have been implanted with an Essure device. According to Bayer, roughly 70% of those women received their implants in the U.S.

In his press release, Gottlieb mentioned that the FDA is currently waiting for Bayer to finish a safety study involving 2,800 women and designed to examine the hazardous side effects of Essure coils. That study is not scheduled for completion until 2023.

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