Bayer Loses $413M for Essure as Lawsuits Pile Up

Bayer faces 3,700 lawsuits for Essure complications. Injured women, physicians, and politicians are lobbying Congress to pull the device from the market.

Essure, a permanent form of birth control, has resulted in reports of nearly 15,000 adverse events and 30 deaths. In 2016 alone, the FDA received 5,016 incident reports for the device.

The number of Essure-related complications prompted the FDA to issue a black box warning November of last year, the highest-level of warning for a medication or medical device.

Essure is made of two nickel-based coils which are inserted in the fallopian tubes. Over a period of three months, the coils create a layer of scar tissue that is supposed to prevent egg fertilization.

But, not only can Essure fail to prevent pregnancyit has a 9.6% failure ratethe coils can also corrode, migrate through the fallopian tubes, perforate the uterus and other organs, and cause pelvic pain, irregular bleeding, allergic reactions, and other serious side effects.

Essure manufacturer Bayer now faces thousands of lawsuits for the device, while injured women, physicians, and politicians lobby Congress to pull Essure from the market.

A Physician Issues a “Public Call to Arms”

Though the device is intended to be permanent, debilitating pain and complications have forced some women to undergo invasive surgery to remove the device.

Bayer and the FDA market Essure as a non-surgical, less invasive alternative to laparoscopic, tubal ligation procedures (getting one’s tubes tied). However, research from Yale shows that women who undergo the procedure are 10 times more likely to require revision surgery than women who undergo tubal ligation.

“Who are [women] blaming? They’re blaming Bayer but they’re also blaming us as their OBGYNs because they trust us.”

In a “public call to arms,” Dr. Julio Novoa, an OBGYN that performs Essure removal surgeries and advocates on behalf of injured women, said that in many cases, removing Essure requires a hysterectomy. These procedures, which remove the uterus, usually require three to four weeks of recovery and costs thousands of dollars.

“How can we justify to our patients who are going in for an outpatient procedure, that we are calling non-surgical, to have to eventually go through a hysterectomy which a lot of these women cannot afford to do?” Dr. Novoa asks.

He goes on to urge physicians to research the complication rate for the device (which he calls “unacceptable”) and to stop blindly listening to product representatives who are motivated by sales. 

“Who are [women] blaming? They’re blaming Bayer but they’re also blaming us as their OBGYNs because they trust us,” he warns.

Bayer Loses $413 Million; Faces Thousands of Lawsuits

Though there haven’t been any settlements or verdicts yet for Essure victims, Bayer is already taking a financial hit for its dangerous birth control device.

In their 2016 financial report, Bayer disclosed losing roughly $413 million USD for Essure, and revealed that as of January 2017, they faced lawsuits from 3,700 patients for Essure complications.

But because Essure is a Class III medical device, among the highest-risk devices which require the strictest FDA pre-market approvals, it complicates how patients are able to hold Bayer accountable for their injuries. Class III medical devices receive FDA immunity from lawsuits that allege defective or dangerous manufacturing and design.

FDA immunity and regulations trump state laws in court. In order to proceed, lawsuits must rely on parallel state laws that don’t impose stricter standards than what federal law requires.

Lawsuits alleging that Bayer is liable for defective device design and for failing to provide sufficient physician training on Essure implantation have so far been dismissed, most recently by Pennsylvania Judge Padova in February.

However, a judge in California allowed lawsuits filed by 14 women against Bayer for failure to warn—the lawsuits allege that Bayer didn’t report more than 32,000 complaints to the FDA—because they rely on a California law that doesn’t preempt federal law. Lawsuits alleging breach of warranty, fraud, and negligent representation in advertising and marketing have similarly withstood federal preemption.

Injured Women Lobby Congress to Reform FDA Regulations

A Facebook group for injured victims, “E-Sisters,” formed a nonprofit to lobby Congress to pull Essure off the market and revoke its pre-market approval.

More than 30,000 injured women have united on Facebook to share resources and fight for justice. A Facebook group for injured victims, “E-Sisters,” formed a nonprofit ASHES—Advocating Safety in Healthcare E-Sisters. The nonprofit is lobbying Congress to pull Essure off the market and revoke its pre-market approval, which would allow women to file lawsuits.

ASHES reports that next week, they will join Congressman Brian Fitzpatrick (R-PA) and Congresswoman Louise Slaughter (D-NY) as they introduce the Medical Device Safety Act of 2017. If passed, ASHES reports, it would remove federal immunity for all FDA class III medical devices, including Essure, making it easier for victims to hold manufacturers accountable. 

Congressman Fitzpatrick’s predecessor, his brother Mike Fitzpatrick (R-PA), introduced the “E-Free Act” (H.R. 3920) in 2015 that sought to revoke FDA’s Essure approval. It was recommended to a committee but never voted on.

This isn’t the first time the E-Sisters have taken matters into their own hands to force the FDA to act. They also helped educate thousands of women in their Facebook group of the importance of filing adverse event reports.

The spike in reported Essure injuries forced the FDA to review Essure’s safety. Last year, the agency ordered Bayer to conduct an ongoing study of 1,400 women to better determine the long-term risks of Essure.

Did you or a loved one suffer complications from Essure?

Bayer shouldn’t be allowed to freely walk away from the thousands of women that were allegedly injured from Essure. If you or a loved one suffered medical complications from the Essure device, our attorneys want to hear from you.  

Contact us today for a free, no-obligation case review. We’ll help determine if you are eligible for a lawsuit. It costs nothing unless we win a jury award or settlement for you.


Hernia Mesh Leads to “Horrible Pain,” Lawsuits

Patients across North America continue to attribute painful side effects to hernia mesh, particularly Ethicon’s Physiomesh and Atrium’s C-QUR products, each of which is now the subject of lawsuits.

Last month a group of Canadians filed a complaint against Johnson & Johnson (which owns Ethicon) over debilitating health issues they say were caused by the mesh. The alleged side effects include perforations, abscesses, and infections. Many plaintiffs say they required revision surgeries to correct these issues.

Thirty-four-year-old Colleen Copland claims her mesh stretched, triggering a recurrence of her hernia. She tells CTV News, “The pain is always there. It feels like my insides are going to explode… It is a horrible pain, to be honest.”

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“You Couldn’t Even Touch Me”

Ivan Richardson echoed Ms. Copland’s claims, saying, “You couldn’t even touch me, I would cry, I mean literally cry and I went to the doctor and they kept saying they couldn’t find nothing.”

Mr. Richardson said that when the doctors cut him open to investigate, they found that the hernia mesh he’d received had rolled up inside his torso.

It’s estimated that 30,000 Canadians received a Physiomesh implant before Ethicon issued a worldwide recall of the product in May 2016.

In a statement, Ethicon said, “At Ethicon, our first priority is to our customers and their patients, and that includes the safe and effective use of our products. Ethicon will defend itself against lawsuits concerning the use of our hernia mesh products.”

Health Canada has recalled or removed from market 12 types of hernia mesh since 2000.

U.S. Mesh Patients File Lawsuits, Too

Hernia mesh products have generated lawsuits in the United States, as well. In addition to Ethicon’s Physiomesh, Atrium’s C-QUR faces at least 21 lawsuits from patients who say they experienced side effects resulting from C-QUR’s fish oil coating. These alleged side effects include the following:

  • Pain
  • Inflammation
  • Adhesions
  • Infections
  • Foreign body reactions

Like Ivan Richardson, U.S. plaintiff Theresa Callaway alleges that her mesh “folded up” and became “bunched up in layers,” leading to pain, nausea, vomiting, infections, and revision surgeries.

These kinds of problems have long plagued surgical mesh. In 2011, C.R. Bard offered to pay $184 million to settle 2,600 surgical mesh lawsuits filed in a Rhode Island multi-district litigation (MDL).

In July 2013, the FDA issued a Class 2 device recall of the C-QUR Edge Mesh.

In October 2012, the U.S. Food and Drug Administration (FDA) warned Atrium about its C-QUR mesh’s potential for infections and its sterility complaints. In July 2013, the FDA issued a Class 2 device recall of the C-QUR Edge Mesh.

In January 2017, a man named James Brown filed a lawsuit against Atrium alleging that he was implanted with the C-QUR mesh in a hernia repair surgery in 2013 but continued to suffer abdominal pain. Mr. Brown says he underwent revision surgery in January 2016 to remove the mesh, during which doctors discovered he suffered from a “foreign body giant cell reaction” and scarring of the surrounding tissue.

Earlier this year, Mr. Brown’s case and 20 others were consolidated into a federal multi-district litigation (MDL).

Meanwhile, the first Ethicon Physiomesh lawsuit in the U.S. is scheduled for January 2018 in Illinois’ Southern District.

Mesh Complications Dampen Financial Forecast

In its five-year forecast of the marketability of hernia repair devices, Research and Markets notes

operation failure and recurrence of hernia in obese and Geriatric patients and also the risks and complications associated with hernia repair surgery and mesh are negatively influencing the expansion of hernia repair devices’ global market.

To pinpoint and avoid exactly these types of complications, yesterday Tela Bio announced that it would conduct a post-market clinical study of its OviTex biological mesh, which is used primarily for hernia repair and abdominal wall reconstructions.

Tela Bio will conduct a post-market clinical study of its OviTex biological mesh.

In a press release, chief medical officer Dr. Maarten Persenaire said, “Surgeon feedback on OviTex performance and surgical handling has been positive so far, and we are excited to initiate a formal clinical data collection program that will support future efforts to refine surgical mesh design and develop new clinical protocols for hernia repair.”

This is a welcome step on Tela Bio’s part, as surgical mesh could absolutely use more scientific scrutiny and design refinements.

If you or a loved one underwent hernia repair surgery and suffered complications from mesh, contact us for a free, no-obligation legal consultation.

Breast Implants May Cause Rare Type of Lymphoma

Breast augmentation surgeries have seemingly gotten safer in recent years, but a potentially lethal health risk now looms for those with textured implants.

Earlier this week the U.S. Food and Drug Administration (FDA) announced that it has received 359 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. Nine of these 359 women died from the disease.

Of the 359 cases the FDA knew about as of February 1st, 231 noted the type of implant. Of these 231, the vast majority—203—had textured surfaces, while 28 had smooth.

This data mirrors a January 2017 study which found that the incidence of ALCL in breasts with textured implants is 67.6 times higher than the incidence of breasts with no implants.

The material of the implants does not seem to affect the incidence rate. Of the 312 reports that included the material, 186 were silicone and 126 were saline.

Our attorneys are now filing lawsuits on behalf of women who contracted ALCL after receiving breast implants. If you or a loved one meet these criteria, please contact us today for a free legal consultation.

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FDA First Noted ALCL Link in 2011

The FDA first noted a potential link between breast implants and ALCL in 2011, but at that point it had not received any reported fatalities. It also lacked a strong enough body of evidence to establish a solid connection.

That changed over the past six years, as the agency received more reports of BIA-ALCL, some of them fatal. The incidents were common and concerning enough that the FDA issued a statement, noting

…we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants.

The FDA stated that it would continue to monitor MDRs, to review medical literature and data from the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE Registry), and to collaborate with “international regulators and health experts.”

The FDA states, “All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants.”

According to the Plastic Surgery Foundation, there were 290,647 breast augmentation surgeries in 2016—which means there could be many more of these BIA-ALCL incidents that have yet to be reported.

About ALCL and Its Symptoms

ALCL is a rare form of non-Hodgkin’s lymphoma (NHL), comprising just one percent of NHL cases and just 16 percent of all T-cell lymphomas, according to the Lymphoma Research Foundation.

It can take up to ten years for ALCL to develop, which helps explain why it took several years for the FDA to go from a potential link to an established one.

Symptoms of BIA-ALCL may include the following:

  • Breast lump or lumps
  • Pain
  • Swelling
  • Fluid buildup

With regard to ALCL treatment options, the LRF says, “If the disease is confined to a single lesion or area, radiation therapy or surgical excision will result in complete remission in approximately 95 percent of patients.”

This aligns with the FDA’s statement on BIA-ALCL, which says that the majority of these cases can be treated by removing the breast implant and surrounding tissue. The FDA does note, however, that some patients may also require chemotherapy and radiation.

It can take up to ten years for ALCL to develop.

If you or a loved one had breast augmentation surgery and developed ALCL, you may qualify for a lawsuit that could help recover compensation for medical bills, lost wages, and pain and suffering. Don’t wait; contact us today for a free legal consultation.

FDA Approves New Power Morcellator Despite Cancer Risks

The U.S. Food and Drug Administration (FDA) has approved a new surgical tool used in minimally invasive gynecological procedures months after it discouraged use of the device over cancer concerns.

Power morcellation has been shown to spread undetected cancer in patients.

Olympus America Inc.’s Contained Tissue Extraction System, a type of laparoscopic power morcellator, was cleared through FDA’s controversial 510(k) program, which requires no testing on human subjects.

Olympus received clearance from the FDA on November 16 for the company’s next-generation laparoscopic PK Morcellator, even though power morcellation has been shown to spread undetected cancer in patients.

Power Morcellation Can Spread Cancerous Tissue

Laparoscopic power morcellation is a surgical procedure for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy). During the procedure, a power morcellator–a device resembling a handheld drill–is inserted through a small incision. It then grinds up tissue into small pieces for removal.

Hysterectomies and myomectomies via power morcellation are associated with fewer complications than the same procedures performed via surgical incision into the abdominal cavity.

But there’s a catch: power morcellation has been shown to spread undetected cancer (uterine sarcoma) in patients. This has led to hundreds of lawsuits filed by affected patients.

Most women will develop uterine fibroids at some point in their lives. While many fibroids are benign, approximately 1 in 350 women have unsuspected uterine sarcoma hidden within fibroids. Power morcellation has the potential to disperse cancerous tissue beyond the uterus, substantially worsening the patient’s long-term survival outlook.

FDA Discourages Power Morcellation for Hysterectomies

In April 2014, the FDA issued a safety communication discouraging use of laparoscopic power morcellation for removal of the uterus or uterine fibroids.

“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal,” said Chief Scientist William Maisel. “Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”

Since the safety communication was issued, rates of power morcellation use for hysterectomy and myomectomy have decreased significantly.

According to a study in the Journal of the American Medical Association (JAMA), the percentage of women undergoing hysterectomy via power morcellation decreased from 13.7% in the fourth quarter of 2013 to 2.8% in the first quarter of 2015. A study reported at the American Society for Reproductive Medicine 2016 Scientific Congress found a 63.9% drop in all myomectomies (both laparoscopic and abdominal) following FDA’s warning.

“Many of the existing studies evaluating the impact of the FDA warning against power morcellation have shown a decrease in use of power morcellation,” Dr. Deirdre Lum told Medscape Medical News.

Dr. Lum suggested that the FDA’s warning may have raised fears about tissue disruption in general, steering patients and their doctors towards other fibroid treatment options.

Olympus Morcellator Cleared Based on “Substantial Equivalence”

The Olympus PK Morcellator is designed for the very same surgeries that the FDA warned against. But whether the PK Morcellator poses equivalent cancer-spreading risk is difficult to determine, because the device did not undergo human testing.

The FDA approved Olympus’ morcellator under its 510(k) program, which allows device makers to forego human testing if the new product is “substantially equivalent” to already-approved devices (so-called “predicate devices”).

FDA documents show few design differences between the PK Morcellator and its predecessor. For example, the PK and its predecessor have the same dimensions, mode of tissue dissection, and sterilization.

New for the PK is a “peeling” method of tissue morcellation, compared to a “coring” morcellation technique used in the predicate. The PK also is designed to be used with the “first of its kind” PneumoLiner containment bag—a device designed to contain morcellated tissue

The FDA, however, acknowledges that “the PneumoLiner device has not been proven to reduce the spread of potentially cancerous tissue during power morcellation.”

PneumoLiner was cleared through FDA’s de novo classification process. Although different than the 510(k) process, de novo classification similarly allows devices to escape the much more rigorous premarket approval process.

Neither the PK Morcellator nor its containment bag underwent human testing.

Research published in The Journal of Minimally Invasive Gynecology found that approximately 1 in 10 morcellation containment bags leaked and spread tissue.

There have been calls for power morcellators to be pulled from the market, or at the very least, classified as high-risk devices, which would necessitate premarket approval testing.

Johnson & Johnson’s Ethicon unit withdrew its morcellators from the market following the FDA’s warning. In March 2016, J&J settled the majority of the morcellator lawsuits it is facing for $100,000 to $1 million per case.

Lawsuits against other morcellator manufacturers are ongoing. Please contact us if you or a loved one had cancer spread throughout your body by a power morcellator.

Johnson & Johnson Can’t Win in Court

The hits keep coming for pharmaceutical titan Johnson & Johnson, which has suffered a series of huge legal and financial blows in 2016. A slew of jury awards and settlements have cost the company hundreds of millions of dollars and severely damaged its credibility in the court of public opinion.

J&J is struggling to fight three mammoth legal battles at once, and the strain is showing both in its courtroom performances and in its bank account.

Hold J&J Accountable

J&J Will Try—Again—to Move Talc Cases Out of St. Louis

After three massive awards for plaintiffs who claimed they contracted ovarian cancer from using Johnson & Johnson’s talc-based products, J&J will attempt to move future talc cases out of Missouri. They tried this once before, last August, arguing that the company and plaintiffs had no ties to St. Louis. The judge dismissed the motion.

The most recent jury award, in October, was $70 million to Deborah Giannecchini. Five months prior, a Missouri jury awarded Gloria Ristesund $55 million.

The first big win for plaintiffs, in February 2016, went to the family of Jacqueline Fox, a woman who passed away from ovarian cancer after a lifetime of using Johnson & Johnson’s Baby Powder for feminine hygiene. Ms. Fox’s family received $72 million.

There are more than 1,000 talcum powder lawsuits pending in St. Louis, and 200 more awaiting their day in New Jersey courts.

Attorney Jere Beasley, whose firm filed the three Missouri cases and hundreds of others, told Fortune, “If I were representing them [Johnson & Johnson], I would say, folks, we need to sit down and regroup and start trying to settle these cases.”

But as of this writing, J&J seems more concerned with upholding its image as a wholesome family company than admitting wrongdoing and reimbursing the hundreds of women who say they have contracted ovarian cancer from using talc products.

J&J Settles Another Risperdal Lawsuit, Avoiding Trial

Talcum powders aren’t the only Johnson & Johnson products that have spawned a mountain of litigation. The antipsychotic drug Risperdal has allegedly caused many young boys to grow breasts, a condition known as gynecomastia. Hundreds of these boys have filed Risperdal lawsuits against J&J, and so far, they have been very successful in obtaining relief.

In July, a Philadelphia jury awarded Andrew Yount a staggering $70 million, ruling not only that J&J had failed to warn Mr. Yount of the risks in taking Risperdal, but that the company had concealed or destroyed evidence related to the case. Mr. Yount, of Tennessee, started taking Risperdal when he was just five years old.

A Philadelphia jury found that J&J had concealed or destroyed evidence related to the Andrew Yount case.

Mr. Yount’s award was the latest in a string of wins for Risperdal plaintiffs. Nicholas Murray was awarded $1.75 million in November 2015, and Austin Pledger was awarded $2.5 million in February 2015.

Perhaps still smarting from all of those losses, earlier this month Johnson & Johnson reached an undisclosed settlement to end a Risperdal case filed by a man who started taking the drug at age seven to manage symptoms brought on by his Asperger’s syndrome. According to court documents, the plaintiff developed permanent gynecomastia.

That is one of dozens of Risperdal cases that J&J has opted to settle out of court.

In November 2013, Johnson & Johnson paid a $2.2 billion fine to settle a Justice Department investigation into its promotion and marketing of Risperdal. This was one of the largest such fines in American pharmaceutical history.

There are 1,500 Risperdal lawsuits still pending in U.S. courts.

Hip Replacement Cases Cost $4.15 Billion and Counting

The most expensive legal battle of all, though, keys on Johnson & Johnson’s defective hip implants. In 2013, J&J settled thousands of claims about its Depuy ASR implants for an estimated $4 billion.

That model is not the only one creating pains for patients and headaches for J&J, though. Johnson & Johnson’s Pinnacle hip implant has generated 8,400 lawsuits, the vast majority of which are currently pending in multi-district litigation (MDL).

A bellwether Pinnacle case recently made it to trial, where a jury awarded plaintiffs $500 million in damages.

One bellwether case, though, recently made it to trial, where a jury awarded five plaintiffs $500 million in damages. (A Texas judge later cut that award to $151 million.) Another bellwether Pinnacle trial went to court in September; there has been no word yet on a verdict. Legal experts feel that another loss for J&J could prompt the company to settle the remaining 8,400 suits.

If you or a loved one have suffered unforeseen physical or financial harm because of Johnson & Johnson hip implants, talc products, or its drug Risperdal, please contact us today to explore your options. Don’t wait; you could qualify for compensation.

Hospital Failures Undermine FDA Device Safety Efforts

Hospitals and manufacturers routinely fail to report medical device-related deaths, injuries, and other safety data to the Food and Drug Administration, in violation of federal rules and to the detriment of medical device safety monitoring. FDA fecklessness often compounds these issues, leading to avoidable patient harm. wants to remind consumers that you can report medical device problems directly to the FDA through its website.

You can also report problems to and find out if you have a legal cause of action against a device manufacturer.

Hospitals and Manufacturers Play Key Roles in Data Collection

The FDA is tasked with balancing the need to quickly bring new, life-enhancing technology to market with the need to ensure device safety and effectiveness prior to marketing. Accordingly, FDA relies on both premarket evaluation (including clinical studies) and post-market surveillance (monitoring devices once they are cleared for sale).

FDA relies on premarket and post-market data to evaluate medical device safety.

Medical device reporting is among the post-market surveillance tools available to the FDA. Federal law requires that hospitals notify the manufacturer within 10 days of a serious injury possibly related to a medical device and notify both the manufacturer and the FDA of a possible device-related death. Hospitals must also submit annual reports to the FDA at the start of each calendar year.

Device manufacturers have reporting duties as well. A manufacturer must file FDA reports within 30 days of learning about an injury or death linked to one of its products.

FDA Inspections Reveal Reporting Lapses

In response to a number of high-profile device safety issues associated with power morcellators and duodenoscopes that hospitals failed to report, the FDA performed inspections at 17 hospitals where issues with those devices allegedly occurred.

The inspections revealed reporting issues at prominent medical centers, the FDA disclosed in October 2016, including at Massachusetts General Hospital in Boston, New York Presbyterian Hospital, and the Ronald Reagan UCLA Medical Center.

Issues uncovered in the inspections include failure to submit required reports, inadequate reporting procedures, and a lack of reporting requirements awareness and training on the part of hospital staff.

Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, addressed these reporting lapses in a blog post and said that while certain hospitals were singled out, the issues are widespread.

“We believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals. We want to work with all hospitals to address these issues,” said Mr. Shuren.

The FDA will hold a workshop in December to discuss ways to improve hospital-based surveillance efforts.

Patients interested in taking a proactive role in medical device adverse event reporting can submit reports online through MedWatch.

FDA Medical Device Oversight Criticized

The FDA’s hospital inspections were driven by criticism that the agency is not doing a good enough job tracking medical devices.

A Senate investigation into superbug outbreaks at hospitals linked to duodenoscopes—tube-like medical devices inserted through the mouth into the stomach and intestine for minimally invasive procedures—found that poor FDA oversight was to blame.

Device manufacturers’ main goal is to quickly get new products to market—not to protect patient health.

“This investigation clearly demonstrates the inability of FDA’s current device surveillance system to accurately identify the extent of device problems when they occur, which poses an unacceptable risk to patients,” concluded the Senate in its January 2016 report.

The report recommends that FDA make changes to its 510(k) approval process, a fast-track process that allows devices to be cleared for sale without rigorous premarket testing if they are “substantially equivalent” to devices already sold. FDA clears dozens of high-risk medical devices each year through the 510(k) process. Many of the most high-profile product defect lawsuits in recent memory have involved 510(k)-approved devices, including metal hips, transvaginal mesh, and power morcellators.

A 510(k) submission is also required when a manufacturer modifies a medical device in a way that might impact safety or effectiveness.

According to the Senate report, manufacturers of duodenoscopes blamed for spreading antibiotic-resistant infections between 2012 and 2015 made substantial design changes to the devices that affected their decontamination specifications, but failed to submit relevant 510(k) applications. By the time the FDA determined applications should have been submitted, the devices had been in use—and spreading infections—for years. At least one manufacturer was aware of contamination problems but failed to disclose them.

The Senate report notes it is up to manufacturers to determine if and when a 510(k) application is warranted. Yet this creates a strong conflict of interest, since manufacturers’ main goal is to quickly get new products to market.

In fact, an over-reliance on manufacturers and hospitals to self-report device safety information places consumers at the mercy of organizations that have incentives not to make rapid and robust disclosures for fear of costly litigation.

While a stronger FDA can help to protect patient safety, patients should take steps to help themselves, such as reporting directly to the FDA and holding companies accountable.

The Trouble with Stryker Hip Implants

Stryker Orthopaedics recently issued a hazard alert warning doctors and patients of potential side effects that may be caused by seven models of Stryker V40 femoral heads, which are used in metal-on-metal (MoM) hip replacement procedures.

These types of procedures have generated many such alerts from health organizations. They have also spawned thousands of lawsuits filed by patients who exhibited severe side effects and/or had to undergo revision surgery as a result of MoM complications.

Hold Stryker Accountable

The side effects cited in the most recent Stryker alert include the following:

  • Loss of mobility
  • Pain
  • Inflammation
  • Adverse tissue reaction
  • Dislocation
  • Joint instability
  • Broken bones
  • Leg length discrepancy
  • Need for revision surgery

Though the alert is not technically a recall, it could certainly discourage surgeons and patients from pursuing total hip replacements that include a Stryker V40 femoral head.

Many companies have ceased producing MoM hip replacements altogether because of the kinds of risks outlined in the alert. When the metal head rubs against the metal socket, metal particles can be released into the bloodstream, leading to cobalt chromium poisoning.

As a result, drug and health agencies worldwide have issued warnings about MoM replacements since as early as 2010.

FDA, Other Agencies Warn of “Unique Risks”

“Metal-on-metal (MoM) hip implants have unique risks in addition to the general risks of all hip implants.”

In the spring of 2010, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning about MoM hip replacements. In this alert the MHRA advised patients to get blood tests and imaging to ensure they didn’t have metal poisoning. Two years later, the MHRA issued a follow-up with guidelines on monitoring and caring for MoM hip patients.

In 2012, Health Canada issued an alert containing important safety information for MoM hip replacement surgeons and patients. This alert noted:

In recent years, there has been an increase in awareness of pain, implant loosening and significant soft tissue reactions thought to be the result of increased levels of metal (cobalt and chromium) ions in the surrounding joint tissue. Soft tissue reactions can range from fluid collection to more extensive necrotic and “pseudotumor” reactions and can necessitate device revision.

Health Canada also reported that “14.2% of revised MoM hip implants exhibited soft tissue reactions.”

Furthermore, the U.S. Food and Drug Administration (FDA) states on the Metal-on-Metal Hip Implants section of its website, “Metal-on-metal (MoM) hip implants have unique risks in addition to the general risks of all hip implants.”

The FDA advocates the following measures for any patient experiencing symptoms that suggest their implant is not functioning as it should:

  • Joint aspiration (removing fluid from around the joint)
  • Soft tissue imaging
  • Blood tests, including checking metal ion levels

The FDA adds that MoM patients should be extra-aware of their general health, as some medical literature suggests MoM hip implants can lead to systemic reactions elsewhere in the body.

Among these potential reactions are skin rash and hypersensitivity, cardiomyopathy, neurological changes, renal function impairment, depression or cognitive impairment, and thyroid dysfunction.

Stryker Hip Implants Lead to $1.4 Billion Settlement

Given the startling health risks laid out by the FDA, MHRA, Health Canada, and Stryker itself, it should come as no surprise that a Rhode Island judge recently denied Stryker’s motion to dismiss a lawsuit pertaining to its Trident hip replacement system.

In fact, the corporation is no stranger to litigation. In the fall of 2014, Stryker agreed to pay $1.43 billion to settle thousands of lawsuits concerning its ABG II and Rejuvenate hip stems. Under the settlement, each plaintiff could receive as much as $600,000 in damages.

If you have experienced metal poisoning, dislocations, pain, inflammation, or broken bones, and you require(d) revision surgery as a result, please contact us today to learn your rights. You may qualify for a lawsuit that could help you pay medical bills and other expenses related to your device’s unforeseen side effects.

Essure Lawsuits Explained in the Context of Federal Preemption

Since it was approved in 2002 about 900,000 women have been implanted with the Essure permanent contraception device. Manufacturer Bayer has acknowledged receiving over 30,000 reports of Essure adverse events, while the FDA has received around 10,000 Essure complaints. A Facebook support group for women suffering from Essure-related health problems—which asks “Has your life become a living hell since having the Essure procedure done?”—has more than 30,000 members.

Federal preemption, Bayer claims, makes it immune to injury lawsuits. But this isn’t necessarily the case.

To date, however, only about 1,000 women have stepped forward and filed Essure personal injury lawsuits.

Clearly, the number of reported Essure problems doesn’t correlate well with the number of Essure lawsuits. A big reason for this is something called “federal preemption” that, according to Bayer, makes it immune from Essure injury claims.

But recently, and in opposition to Bayer’s legal arguments, judges have allowed certain Essure claims to proceed. takes a look at what federal preemption means for women seeking redress for alleged Essure injuries, why some claims have been allowed to proceed, and why Essure may serve as a springboard for a broader preemption discussion.

Federal Preemption

Federal preemption is a legal concept rooted in the U.S. Constitution’s Supremacy Clause (Article VI, Paragraph 2), which establishes that the federal constitution (and federal laws in general) are the supreme law of the land. In other words, where state and federal statutes, regulations, and common law civil actions come into conflict, federal law takes precedence.

There are two types of federal preemption: explicit and implicit. Explicit preemption occurs when a federal statute expressly reserves to the federal government an area of legislation. Federal law can also preempt state law implicitly, even if it does not do so explicitly, if the enforcement of state law interferes with federal purposes.

Lawmakers don’t have perfect foresight. New legislation as well as societal changes (particularly technological ones) make it necessary at times for courts to interpret whether there is a genuine conflict between a state law and a federal law on the same subject. These interpretations create precedents that come to bear on relevant future questions of federal preemption.

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FDA Authority

The Federal Food, Drug, and Cosmetics Act (FDCA), passed in 1938, authorized the Food & Drug Administration (FDA) to oversee food, drug, and cosmetics safety. Its passage, prompted by the poisoning death of 107 people from a legally marketed toxic elixir, gave the FDA authority to demand safety evidence for new drugs.

Congress added the requirement in 1962, through the Kefauver-Harris Amendments, that FDA demand evidence of product effectiveness, in addition to evidence of safety. The 1976 passage of the Medical Device Amendments (MDA), which followed a Senate finding that faulty medical devices were responsible for more than 700 death and 10,000 injuries, extended safety and effectiveness standards to new medical devices.

MDA also contains an express preemption clause (21 U.S.C. §360k) that says state device requirements for safety and effectiveness cannot trump federal (FDA) requirements. Importantly, however, the clause does not prohibit states from imposing standards that run parallel to federal law, does not expressly prohibit medical device lawsuits based on state tort claims, and only applies to Class III medical devices (the highest-risk medical devices, subject to the highest level of regulatory control).

Riegel v. Medtronic

A Supreme Court ruling in a 2008 case involving the question of federal preemption created the precedent that is currently making it difficult for women harmed by Essure to file personal injury lawsuits.

Courts cannot enforce state laws on medical devices with Premarket Approval, unless the regulations are the same as corresponding FDA regulations.

In Riegel v. Medtronic, Charles Riegel brought suit under New York law against device manufacturer Medtronic after a catheter—an FDA-approved Class III medical device—burst in his coronary artery during surgery. Medtronic argued that because the device was subjected to FDA approval requirements, letting the case proceed would impose state requirements and undermine FDA power.

The court agreed but Riegel challenged the ruling. Eventually the issue was put before the Supreme Court, which upheld the decision. Riegel v. Medtronic thus established that federal preemption applies to devices determined to be safe and effective by the FDA through its rigorous premarket approval (PMA) process (although devices approved through the less-stringent 510(k) process are a different story).

As a result, courts cannot enforce state regulations on medical devices with PMA, unless the restrictions are the same as corresponding FDA restrictions. This caveat provides a small window of opportunity for plaintiffs to bring state law medical device claims against PMA-approved devices.

Essure Lawsuits

A recent California state judge ruling has given some hope to women with Essure injury claims.

On August 2 Alameda County Judge Winifred Smith ruled that a narrowed set of claims from 14 women could proceed against Bayer because they sought to impose a parallel standard (rather than a different or tougher standard).

Smith said that the women’s failure to warn claims, which allege that Bayer did not report more than 32,000 Essure complaints to the FDA, were not preempted under California law. Also not preempted were breach of warranty, fraud, and negligent misrepresentation claims over advertising and promotional materials not subject to FDA approval. Plaintiff claims for manufacturing defect and negligent training of physicians, however, are preempted, Smith ruled.

A Pennsylvania federal judge similarly ruled earlier this year that a narrow set of claims, including those for negligent misrepresentation and negligent failure to warn, could proceed. But a different California judge ruled in February that an Essure lawsuit could not proceed due to federal preemption. These different outcomes reveal the significance of state law, as well as the importance of judicial interpretation of those laws, when it comes to preemption.

Bills Seek to Undo Preemption

The 1976 Medical Device Amendments was not intended to grant manufacturers of defective medical devices immunity from personal injury lawsuits. Yet thanks to the Supreme Court’s ruling in Riegel v. Medtronic, that is precisely what has happened.

Rep. Mike Fitzpatrick has introduced two bills that would make Essure lawsuits easier.

In 2012 the Supreme Court declined a petition to review a case (Walker v. Medtronic) decided by the U.S. Court of Appeals which had confirmed MDA preemption as interpreted in Riegel v. Medtronic. The Supreme Court’s refusal to review the decision preserves the current preemption analysis being implemented by the federal courts. This has led to legislative efforts aimed at stripping device makers of the preemption defense.

Rep. Mike Fitzpatrick (R-PA), working closely with Essure victims, introduced in November 15 the “E-Free Act” (aka H.R. 3920). If passed, the Act would withdrawal FDA approval of Essure, thereby making the federal preemption argument irrelevant.

Fitzpatrick also introduced H.R. 5403 (Ariel Grace’s Law), a bill that would amend section 360k of the Food, Drug, and Cosmetics Act so that “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.”

Both of Fitzpatrick’s bills were sent to committee in June 2016.

FDA Medical Device Standards Fail to Protect Public

Giving the FDA the last word on medical device safety may not be the wisest idea, considering the agency’s track record of approving devices based on questionable evidence.

Essure is a textbook example of FDA approval shortcomings. A Northwestern University study published in 2016 looked at 18 Class III devices approved by the FDA from 2000 to 2015 and found that 22% were given market clearance despite a failure to show effectiveness during clinical trials. The study authors noted that Essure approval was based on short-term evidence and insufficient post-market follow-up.

Of the PMA process in general, the study’s lead author said, “Despite this being the most stringent pathway, and despite the fact that we’ve had multiple safety issues connected to OB-GYN devices affection millions of women worldwide, the evidence leading up to approval has a lot of weaknesses.”

FDA did finally order Bayer to conduct a postmarket surveillance study about Essure’s benefits and risks—more than 14 years after it was initially approved, and only after tens of thousands of women filed adverse event reports. FDA additionally ordered a “black box” warning be added to Essure based on concerns over serious complications such as abnormal bleeding, autoimmune reaction, and tearing of the uterus or fallopian tube. Again, this move was too little too late for women who would have benefited from a stronger warning in the first place.

If the FDA cannot ensure the safety and effectiveness of medical devices, then injured patients at the very least need a clear path to personal injury lawsuits. Absent corrective legislation, medical device users will continue to be at the mercy of an organization that has shown it is incapable of protecting the public health.

Attorney Choice Matters in Essure Lawsuits

Courts’ interpretation of medical device preemption laws make it very difficult—but not impossible—to successfully bring Essure lawsuits.

Plaintiffs have a narrow window through which to assert their Essure injury claims. Their arguments and the evidence used to support them must be extremely solid. For these reasons, it is of the utmost importance to work with an experienced, knowledgeable personal injury attorney who can craft a legal strategy that survives Bayer’s dismissal efforts.

To learn more, schedule a free case review with

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Northwestern Medicine Study Highlights Flaws in FDA Device Regulation

Most women probably assume that medical devices used in obstetrics and gynecology are thoroughly tested before introduction to mainstream medicine. However, a new study out of Northwestern Medicine shows why faith in the regulatory process is misplaced and demonstrates how dangerous devices can make their way onto the market and into women’s bodies.

“Despite the fact that we’ve had multiple safety issues connected to OB-GYN devices affecting millions of women worldwide, the evidence leading to approval has a lot of weaknesses.”

Several obstetrics and gynecology medical devices—including Essure permanent birth control, laparoscopic power morcellators, and transvaginal mesh—have been the subject of recent controversy (as well as lawsuits) due to high rates of complications. These devices have a common link, according to researchers at Northwestern University: they were approved by the FDA based on flawed data.

The researchers looked at 18 high-risk OB/GYN medical devices approved from 2000 to 2015 and found that:

  • Four devices were approved despite failure to demonstrate efficacy in clinical trials.
  • Six devices were not required to undergo postmarketing surveillance to measure ongoing safety.
  • Nearly half of the devices were approved based on nonrandomized controlled trials (the randomized controlled trial is considered the “gold standard” of clinical trials).
  • Three devices were withdrawn from the market; of these, two were not reviewed by experts on the FDAs obstetrics and gynecology advisory committee, and the other was reviewed by the panel but not recommended for approval.

“We looked at the class of devices with the highest potential risk to patients—the devices that had to go through the most rigorous pre-market approval process,” said Dr. Steve Xu, the study’s senior author. “Despite this being the most stringent pathway, and despite the fact that we’ve had multiple safety issues connected to OB-GYN devices affecting millions of women worldwide, the evidence leading to approval has a lot of weaknesses.”

Researchers Point to Failings of Essure

The researchers used Bayer’s Essure permanent birth control as an example of how weaknesses in the FDA medical device approval process can lead to patient harm.

Essure was approved in 2002 based on short-term evidence and inadequate post-market follow-up, the study authors said. It has been linked to more than 10,000 injuries, including severe pain, organ damage, and unintended pregnancy.

“There are no explicit requirements about conducting randomized-controlled trials or post-market surveillance for medical devices.”

In one premarket study used to approve Essure, 9% of women reported adverse events, but the device was approved based on the fact that no pregnancies were reported during testing. Although the FDA ordered post-approval studies for Essure, these studies were found by the New England Journal of Medicine to have serious limitations, such as short follow-up periods, the exclusion of key data, and a lack of a comparison group (i.e. a controlled study).

Independent, controlled testing has found that Bayer’s Essure device has a much higher failure rate than pre and post-marketing data indicate.

FDA ordered in March 2016 that a “black box” warning be added to Essure and additionally called for Bayer to conduct new studies of the device.

“There are no explicit requirements about conducting randomized-controlled trials or post-market surveillance for medical devices,” said Dr. Xu. There are much higher standards for the approval of new drugs. The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?”

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More Stringent Device Regulation Needed

The research team emphasized the need for greater scrutiny of medical devices, even as legislation opposed to this is making its way through Congress.

The 21st Century Cures Act, an industry-friendly bill that contains a broader definition of “valid scientific evidence,” passed the House of Representatives in May 2015 and is currently before the Senate.

“Our concern,” said study author Jessica Walter, “is that this would lead to more devices getting approved with even less clinical evidence that they are both safe and effective.”

Walter and Xu suggested that both physicians and the FDA have a role to play when it comes to bringing higher quality studies into the device approval process. They added that evidence shows more regulation doesn’t necessarily mean less innovation.

“Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems” is published in the June 2016 edition of Obstetrics and Gynecology.

Judge Allows Philadelphia Essure Suit to Proceed

In a major victory for five plaintiffs who allegedly suffered serious injuries after receiving Bayer’s Essure sterilization device, a Pennsylvania judge has allowed their case to proceed.

Bayer had asked Judge John R. Padova to throw the case out because Essure received pre-market approval (PMA) from the FDA in 2002. But, in yet another blow to the reeling pharmaceutical giant, Judge Padova allowed the case to continue on two counts: Bayer’s use of deceptive advertising, and its failure to warn consumers of Essure’s risks.

Hold Bayer Accountable

The Essure procedure, which is irreversible, involves implanting two tiny nickel-titanium coils into the fallopian tubes to prevent fertilization. Despite Bayer’s claims that it is 99% effective, there have been thousands of Essure-related adverse events since it hit the market in 2003.

Among the Philadelphia plaintiffs is Heather Walsh, who said her Essure coils migrated to her uterus, triggering serious health complications, hospitalizations, and eventually a hysterectomy.

Sadly, there are thousands more stories like Ms. Walsh’s. Complications are so rampant among Essure users that they spawned a support group on Facebook called Essure Problems. Since its 2011 founding, the group’s membership has grown to 28,000.

Across the country, hundreds of Essure users have filed lawsuits against Bayer. Because the Philadelphia case is the farthest along, legal experts, attorneys, and plaintiffs are monitoring it closely for the precedent it will set.

A Brief History of Essure

When it first hit the market in 2003, Essure was hailed as a safe, painless, and less invasive alternative to tubal ligation (having one’s tubes tied). The pre-market studies went well, and early on, women reported very few side effects.

As time went on, though, it became clear that Essure was not as safe or painless as Bayer claimed.

The studies conducted before Essure hit the market were mostly short-term, and many were deeply flawed.

From November 2002 to October 2013, there were 943 adverse event reports related to Essure: an average of roughly 86 per year. In 2013 alone, the number jumped to 817. The next year, it skyrocketed to 2,259.

In 2011, Angie Firmalino founded the Facebook group Essure Problems, and later, a nonprofit group called ASHES: Advocating Safety in Healthcare E-Sisters. (Essure victims call themselves E-Sisters.) In 2014, famed consumer advocate Erin Brockovich joined the fight, launching a website where women can tell their stories and sign a petition calling for a ban of Essure.

The following year, a study of more than 50,000 women found that those with Essure were ten times more likely to need a follow-up operation versus those who opted for surgical sterilization.

Last month, the FDA ordered stronger “black box” warnings for Essure, which will “Note the types of significant and/or common adverse events that may be associated with the device and its insertion and/or removal procedures,” and “Include a statement noting that these risks should be conveyed to the patient during the woman’s decision-making process.”

The FDA also asked Bayer to conduct new studies of the device to more accurately assess its risks and complications.

But for E-Sisters, doctors, and lawmakers who have called for an outright ban, the new FDA guidances feel like half-measures. To date, the FDA has received more than 5,000 complaints of Essure adverse events.

Bayer Facing Hundreds More Lawsuits

Naturally, given the thousands of complaints and serious side effects, Bayer is now mired in hundreds of lawsuits nationwide. Though the Philadelphia case is the farthest along, it is just the first in a giant wave of litigation that Bayer hopes to beat back. Judge Padova’s ruling does not bode well for Bayer’s odds of quashing these lawsuits before they reach trial.

Hold Bayer Accountable

The severe and debilitating nature of the injuries sustained by plaintiffs won’t help Bayer’s case, either. Many women have reported becoming pregnant while on Essure; some have miscarried or given birth to children with defects. Some of the other side effects reported include:

  • Pain/Abdominal Pain
  • Menstrual Irregularities
  • Headache
  • Fatigue
  • Bloating
  • Bleeding
  • Weight Fluctuations
  • Patient Device Incompatibility (e.g., possible nickel allergy)
  • Migration of the Device or Device Component
  • Device Operating Differently Than Expected
  • Device Breakage
  • Malposition of the Device
  • Organ Perforation
  • Dyspareunia (difficult or painful sexual intercourse)

If you have used Essure and would like to explore your legal options, can help.

Our attorneys have decades of experience fighting for the rights of victims who encountered surprising and unwanted side effects from drugs and medical devices. We have fought large pharmaceutical and medical corporations on behalf of our clients and have won millions of dollars in the past.

Contact us for a free evaluation to determine whether you might be entitled to compensation.

FDA Issues New Black Box Warnings for Essure

The U.S. Food and Drug Administration (FDA) has ordered stronger “black box” warnings for Essure, the surgery-free sterilization procedure sold by Bayer since its FDA approval in November 2002.

The new guidances ask that the boxed warning “Note the types of significant and/or common adverse events that may be associated with the device and its insertion and/or removal procedures,” and “Include a statement noting that these risks should be conveyed to the patient during the woman’s decision-making process.”

The FDA has also asked Bayer to conduct new studies of the device to more accurately assess its risks and complications. These guidances arrive in the wake of more than 5,000 Essure-related adverse events, and a 2015 study that found that women who received Essure instead of having their tubes tied were ten times more likely to need a second operation.

Hold Bayer Accountable

Congresspersons like Mike Fitzpatrick (R—PA) and Rosa DeLauro (D—CT), consumer groups like Public Citizen, advocates like Erin Brockovich, and thousands of women have long pushed for an outright recall of Essure. Many expressed disappointment in the FDA’s decision not to ban the procedure.

Sara Sorscher, an attorney for Public Citizen, said, “The FDA unacceptably puts patients at risk by allowing the device to continue to be marketed as this surveillance study proceeds.”

The FDA’s deputy director for science in the center for devices and radiological health, Dr. William Maisel, told reporters, “The agency continues to believe the product should remain available to women who are informed of the risks.”

What Is Essure?

Essure, which hit the market in 2002, is the only permanent, nonsurgical birth control method in the United States. The procedure involves implanting two tiny nickel-titanium coils into the fallopian tubes to prevent fertilization. It takes just 10-15 minutes, and most women go home within an hour after the procedure. About three months later, they can stop using traditional birth control and rely on Essure.

For years, the device seemed like an affordable, safe, and highly effective alternative to tubal ligation (having one’s tubes tied). But most early studies were short-term, and in recent years, reports of severe side effects have soared.

Complications range from pain and bloating to coils breaking and piercing organs. Many women say the procedure—which is irreversible—ruined their lives.

Bayer maintains that, when used properly, Essure is extremely safe and effective (99%, according to them). But tens of thousands of women disagree, and the new FDA warnings seem to vindicate their claims.

Adverse Events Skyrocketed from 2012 to 2015

The new study will involve more than 2,000 women who will be monitored for at least three years. Past studies were not so extensive and followed a relatively small number of women for a relatively short period of time. For example:

  • Seventy-five percent of the 745 women studied before Essure hit the market were not consulted two years after having the device implanted.
  • In a five-year study conducted shortly after Essure became available, nearly a third of women were not followed up with through the end of the study.
  • A 2009 study, which determined that “Only a few small risks are associated with the procedure,” was also short-term.

The length of these studies is crucial because side effects often don’t manifest for years. From November 2002 to October 2013, there were 943 adverse event reports related to Essure: an average of roughly 86 per year. In 2013 alone, the number jumped to 817. The next year, it skyrocketed to 2,259.

Pursue A Lawsuit

Complications are so rampant among Essure users that they spawned a support group on Facebook. Angie Firmalino founded Essure Problems in 2011; its membership has since grown to over 27,000. Firmalino has also created a nonprofit group called ASHES: Advocating Safety in Healthcare E-Sisters.

In 2014, famed consumer advocate Erin Brockovich joined the fight, launching a website where women can tell their stories and sign a petition calling for a ban of Essure.

Many Patients Exploring Legal Options

Despite thousands of complications, Essure remains on the market. Patient health has been put at risk; some of the serious side effects reportedly caused by Essure include:

  • Pain/Abdominal Pain
  • Menstrual Irregularities
  • Headache
  • Fatigue
  • Bloating
  • Bleeding
  • Weight Fluctuations
  • Patient Device Incompatibility (e.g., possible nickel allergy)
  • Migration of the Device or Device Component
  • Device Operating Differently Than Expected
  • Device Breakage
  • Malposition of the Device
  • Organ Perforation
  • Dyspareunia (difficult or painful sexual intercourse)

If you have used Essure and would like to explore your legal options, the attorneys at can help.

Our attorneys have your best interests at heart, and the experience and skills to win in court. We stand ready to evaluate your case and determine whether you are entitled to compensation for any injury or medical costs related to your use of Essure.