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  • Three devices were withdrawn from the market; of these, two were not reviewed by experts on the FDAs obstetrics and gynecology advisory committee, and the other was reviewed by the panel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?”

File an Essure Lawsuit

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.

Pursue Justice

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, ClassAction.com 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 ClassAction.com 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.