medical devices Archives - Hormones Matter

The Essure Debacle

Published on March 13, 2019

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The Essure medical device consists of metal coils that are inserted into a woman’s Fallopian tubes in an attempt to prevent conception. This product was intended to be a non-surgical method of sterilization, and it is the only one of its kind to be approved by the Food and Drug Administration (FDA). As of the end of 2018, thousands of adverse events had been reported by patients, physicians and other healthcare providers because of Essure. The side effects reported were often severe, some involving multiple surgical procedures to remove the metal coils. As a result, the product was under scrutiny for its safety and effectiveness for a long time. Despite the scrutiny, the product manufacturer Bayer expressed that they stood by the safety and efficacy of the device.

Essure Side Effects

In 2015, it was estimated that thousands of Essure patients required operations to correct the device’s faults in the past several years. Apparently, the device would travel from the implantation location and tear through the uterus or other nearby organs. Additionally, the scar tissue that was supposed to form around the device after implantation and prevent pregnancy, sometimes became extensive, and as a result, some women developed autoimmune disorders that was attributed to the immune reaction induced by the device.

Thousands of women sought legal advice to take action against the manufacturer over not only the major adverse events, but the sterilization failure rates as well. Nearly 10% of users are at risk of unplanned pregnancy when Essure is their sole method of birth control, according to researchers. Tubal ligation, a more traditional method of sterilization, has a failure rate of 1 out of every 1,000 women in the first year alone. Some of these women who experience unintended pregnancies while using Essure also endured miscarriages, stillbirths, and ectopic pregnancies.

Aside from the tears and perforations, Essure has several other reported side-effects that women often experience. Immediately following the procedure, women commonly reported mild to moderate pain or discomfort. Within a few days, women also report headaches, weight fluctuation, fatigue, depression, pain with sex, abdominal pain, back pain, severe pelvic pain, as well as severe menstrual cramps. Some women say these go away within a few weeks or months, but a lot of women experience this pain chronically.

In the summer of 2018, the product’s manufacturer, Bayer AG, announced they were voluntarily discontinuing sales of the device. This was after the FDA restricted sales and distribution of the device, as well as stepped in many times to regulate the product.

How Essure Was Approved

The FDA requires a Premarket Approval (PMA) to review and evaluate the safety and effectiveness of Class III medical devices like Essure. FDA regulations require that this takes 180 days, and normally longer, but there are records that show that this process was expedited and several trial candidate’s records were altered to obscure unfavorable data. Some patients were completely thrown out of the clinical trials when their data reflected poorly on the device. According to the citizen’s petition linked above, there were many adverse events that Essure manufacturers and PMA holders failed to report and/or covered up. Additionally, over 16,000 patient complaints were withheld from the FDA. When the manufacturing facilities were inspected, many unsettling thing came to light, starting with the facility’s lack of license. The manufacturer of Essure were operating without a license for three years.

In recent years, the FDA began enforcing label changes, as well as other methods to regulate the product and its potential risks. In 2016, they required a boxed warning to be placed on the product to warn providers of the risks that could come with Essure implantation. Black box warnings are the most serious warnings required by the FDA and indicate the severity of the risks of the medication. Another major step in regulation was the introduction of a patient decision checklist that would be reviewed before implantation by both the physician and the patient together. When the FDA began regulating sales, they made it so only patients that reviewed this checklist could use Essure.

Device and Regulatory Failure

Thousands of Essure patients have experienced adverse events as a result of the device. Essure was intended to be an easier method of sterilization, as it was non-surgical and required no general anesthesia. The recovery time was supposed to be minimal, and women could return to daily activities the same day of implantation. Instead, thousands of women ended up with chronic pain, and sometimes even children they did not intend to have.

The medical device industry remains largely unregulated to this day. A recent documentary, The Bleeding Edge, highlights the resulting adverse health outcomes that result from this lack of regulation. Several women with Essure failures are interviewed. It is worth watching if you or a loved one is contemplating a medical device.

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Will the Sunshine Act Curb Pharma Payments to Doctors?

by Chandler Marrs, PhD

Published on February 12, 2013

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Just two weeks ago, as part of the Affordable Care Act, the Centers for Medicare and Medicade Services published its final rule on the reporting mandates for physician payments from pharmaceutical and medical device makers. Called the Physician Payment Sunshine Act, this law requires:

applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (“covered recipients”).

Why Is This Important?

For too many physicians, the medications they choose to prescribe are influenced by these payments. A case control study at a university hospital found that physicians who requested a new drug be added to the formalary were 19X more likely to have received money or gifts from the drug company. According to the New England Journal of Medicine as of 2007 fully 94% of all physicians accepted gifts from pharma, although by 2009, only 84% of physicians accepted gifts from pharma.

In their Dollars for Docs series, Propublica not only detailed the trail of money from the pharmaceutical industry to physicians and the changes in prescribing practices that ensued, but also, found that over 250 of the physicians receiving these payments had been disciplined by their state’s medical boards with the public never the wiser.

Wouldn’t you want to know if your physician was receiving payments to ‘consult’ on a particular drug or medical device? What if that drug or device turned out to be dangerous like, Avandia or Vioxx or in the case of women’s health Yasmin, Yaz or Ocella or even the vaginal mesh implants? I would. And soon, you will be able to find this information, at least for those physicians that accept medicare or medicade. For the remaining physicians, we’ll have to rely on the stellar, investigative reporting of organizations like Propublica.

What Is the Physician Payment Sunshine Act?

The Physician Payment Sunshine Act mandates payments or ‘transfer of value’ to physicians be reported to the Secretary of Health and Human Services. Collection of this information is set to begin in August with full compliance and reporting expected in 2014.

The cool thing about this act, if it is implemented correctly, is that payment or transfer of value includes money for marketing activities, such as promotional or conference talks and consultation services. It also will include research grants and “charitable” contributions (which usually come with some promotional strings attached), funding to attend conferences, honoraria and royalties and license fees. The pharmaceutical and device companies making these payments will be required to list names, address, amount of payment, date of payment(s) and describe the service for the payment made for anything over $10. The database will be searchable so that patients can determine what monies their physicians received from pharma or device companies.

Where the Sunshine Act Fails

From the original to the final regulations, a work-around for paying physicians to speak at pharma sponsored continuing medical education (CME) events was added. According to the regulations, so long as the sponsoring company doesn’t pay the physician/speaker directly, those fees are acceptable and need not be listed publicly. Instead, the pharma company must pay a third party vendor to arrange and pay the speakers. CME conferences are where most physicians learn the latest drug therapy, device or medical technique. It is unlikely that speakers at these conferences will speak against the sponsor’s product. Funneling the payments through a third party vendor, who is also paid by the sponsor, is no more than a quick pass at laundering the fees.

What Do Physicians Think About the Sunshine Act?

The opinions are mixed, at least publicly. Some physicians are fully behind the new efforts in transparency and have begun their own campaigns to disentangle the marketing relationships between pharma and physicians. The National Physicians Alliance sponsors the Unbranded Doctor campaign:

The National Physicians Alliance’s Unbranded Doctor is unmasking the pharmaceutical industry’s bogus claim that its marketing efforts are just educational ventures for physicians. By signing up physicians to renounce gifts, lecture fees, and “education” from companies, the Alliance is championing objectivity, integrity, and professionalism.

—Jerome Kassirer, MD
former Editor-in-Chief, New England Journal of Medicine

Similarly, the British Medical Journal (BMJ) has positioned itself as a lead proponent of transparency and open data. On the other hand, CME released a survey of over 500 physicians asking if the new regulations to list publicly whether industry sponsored their attendance at CMEs would curtail their attendance. The result was a resounding – yes.

75% of physicians said the disclosure rules would affect their decision to attend at least somewhat.
47% of physicians said the disclosure rules would affect their decision to attend to a great extent.
46% of CME speakers said the disclosure rule would affect their decision to participate as a panelist or presenter to a great extent
25% percent said it would somewhat affect their participation

Will the Sunshine Act Curb Pharma Payments to Doctors?

Probably not. Unless and until full transparency about medical research, clinical trials and adverse events are made open and accessible to patients and physicians, medical marketing, fabricated data or omitted data, publication bias, and conflicts of interest will continue to pervade our healthcare system. Dangerous medications like the Yasmin suite of birth control pills and unsafe medical devices like J&J’s Gynecare Prolift will remain on the marketplace long after any reasonable person could vouch for their safety.

The Sunshine Act will, however, give patients one more tool to evaluate their physicians and give researchers, investigators and others a way to identify and publicize bad behavior. Who knows, maybe it will even save some money.

To find out if your physician receives money from the pharmaceutical industry go to Dollars for Docs.