Presentation to FDA Panel: "Precision Device" Framework for FDA: Is Essure Medical Device "Right for You?"

Here is my panel presentation to FDA Ob/Gyn Panel on Essure Sept. 24, 2015.

Here are the six slides I presented:

The testimony is on pages 173-175 of the FDA Hearing Transcript here.

Steven Brill's Brilliant Expose, America's Most Admired Lawbreaker: Pharma

Steven Brill's America's Most Admired Lawbreaker reveals the inside story of Johnson & Johnson's pharmaceutical marketing gone bad. His accounts of aggressive off-label marketing of its anti-psychotic drug Risperdal to children and elders, paying for steering and revising medical research and journal articles, and building partnerships to market off-label uses are electrifying.  
Here are the chapters of Brill's 15-day serialized series in Huffington Post.

Chapter 1. The Credo Company - J&J's evolution from its founder's credo of putting patients first to today, putting its management and shareholders first. 
Chapter 2. Blowing Past the Label - Marketing plan and SWAT team go off label.
Chapter 3. Sales Over Science - Risperdal legos. 46% of sales children, elders.
Chapter 4. Massaging the Data, Spreading the Word - Buying research.
Chapter 5. Three Card Monte - How to get away with data manipulation.
Chapter 6. Trouble - The Yo Yo Ma Brochure, and a Whistleblower emerges.
Chapter 7. A Multi-Front War - Cooking research findings for FDA, hiding weight gain and male breast development.
Chapter 8. Firing Blanks, Hunting for Smoking Guns - Gods, Doctors who would be Gods, Conflicts of Interest.
Chapter 9. Under Siege, Ducking and Weaving - Too Big to Nail, so the Game Plays On.
Chapter 10. Chess, at $1,000 an Hour - Playing Wizard's Chess with children's and elders' health at stake.
Chapter 11. Pleasing Wall Street - A plea to settle on illegal marketing to elders, in exchange for a skate on illegal marketing to children.
Chapter 12. Showdown, Almost - Unconscionable. How will candidates for President address this?
Chapter 13. Hardball - Thank goodness for David Kessler. Throw the book at pharma, devices and research crimes against humanity.
Chapter 14. The Good Soldier, The Good Mother, The Faded Star - Time to throw the moneychangers out of the temples of our bodies.
Chapter 15. The Verdict... And Moving On - Pulitzer Prize please. The best since Watergate. 

Thank you, Steven Brill, for an excellent narrative, cross, and summation. The honor system has become a dishonor system, and the sky's the limit. The FDA and U.S. Justice Dept. fiddle while American lives and health go up in flames. 

Reading this series is captivating, electrifying, and nauseating. What I find most troubling is that the US attorneys investigating would spend years and years developing evidence, rather than alerting FDA and taking swift action to protect the public. Think about that each time you consider taking a new drug, or installing a new medical device, that the time for the system to catch up with harm inflicted can take years or even decades.

The FDA drug approval system, which Steven Brill describes as an "honor system," clearly broke down and became a dishonor system. This is the system that Congress now wants to fast track through the 21st Century Cures bill, which the House passed in July. Call your Senators and tell them to put patient safety first. 

We need a Precision Medicine and Precision Devices framework to ensure something is "right for you" before use. Patients vary and are not all average. Here is a petition for Medical and Dental Device Safety Urgent Reform: MEDDSURGE.

NEJM Calls for Revisiting Essure Safety

NEJM published Revisiting Essure - Toward Safe and Effective Sterilization, on the eve of the FDA's Panel Hearing on the Essure permanent contraceptive device. The Essure procedures works by inserting two nickel-titanium coils coated with plastic PET into the fallopian tubes, inducing scarring to prevent passage of the egg to prevent pregnancy. It states:

"The upcoming meeting of the Obstetrics and Gynecology Devices Panel represents a clear opportunity to impose requirements that will more fully elucidate the safety and effectiveness of Essure. A new study focused on patient-centered end points — unintended pregnancy, device migration, tubal perforation, bleeding, pain, and events such as hysterectomy and death — in all enrolled women is needed to provide clear estimates of device performance. Such a study should compare outcomes in women receiving Essure with those in women undergoing laparoscopic sterilization, the standard of care, and should be overseen by an impartial, off-site data and safety monitoring board performing periodic, planned reviews with follow-up for at least 5 years."

"The problems of inadequately rigorous premarketing and postmarketing studies, unregistered clinical trials, and incomplete and delayed dissemination of results are not unique to Essure. Most FDA-required postapproval studies are smaller than the premarketing studies, most follow patients for 1 year or less, and nearly half lack comparator groups.5 The 13-year history of Essure emphasizes the necessity for thorough examination and timely reporting of patient outcomes in well-conducted premarketing clinical trials and dedicated follow-up in postmarketing studies. Only then will we better understand the risks and benefits of various devices. In the case of Essure, these data would allow women to make more informed decisions regarding hysteroscopic sterilization." 

The stories, pictures and experiences women and physicians share at the FDA hearing Thursday are even worse.

Why not call for a moratorium on placement while additional post-market studies are conducted on women already implanted with the device, instead of multiplying the potential for harm, while serious questions of risk have surfaced based on evidence?

Who does the FDA calculation weighing risks and benefits of a device for approval, for warnings, and for removal from the market?  What factors are involved? Whose benefits, and whose risks?  It seems FDA weighs company benefits over patient risks.  Patient benefits are artificially inflated given the existence of safe and effective alternatives, and FDA seeks more to minimize company risks than patient risks.

Update: It was an honor to meet Dr. Ailene M. Gariepy, M.D., M.P.H. of Yale School of Medicine, co-author of this article, at the FDA Panel Hearing on Essure September 24th.

Good Morning America with Melanie Goshgarian on Essure Problems, Sept. 22, 2015

Hear Melanie Goshgarian tell her story on ABC Good Morning America Sept. 22, 2015. Essure women are an amazing force. Join women from across the U.S. at the FDA Panel Meeting on Essure Sept. 24, 2015.

Discovering Essure’s problems the hard way

Discovering Essure’s problems the hard way

MetroWest Daily News

By Melanie Goshgarian and Laura Henze Russell
Guest Columnists

September 04. 2015 11:05PM

FDA’s medical device standards outdated, ineffective

Here is a warning for women: do your homework before putting anything in your body. Why? The Food and Drug Administration (FDA) rules governing medical device safety are about 40 years old. They are practically medieval when it comes to patient health and safety.

Can social media and digital apps track illness and help save health? Yes, says a new study by Epidemico, a Boston-based digital health innovator which partnered with the patient illness group, Essure Problems. The study combined social media outreach with the MedWatcher tool to encourage women with medical device illnesses to report problems to the Food and Drug Administration (FDA). Lead author Chi Y Bahk presented it at a major conference in Boston.

This helps to build a more robust database of side effects for an upcoming FDA hearing on the safety problems with Essure, a form of permanent birth control. Essure is made of a nickel titanium alloy and a polyester-like fiber called polyethylene terephthalate (PET). It triggers an inflammatory response, causing scar tissue to form and block the fallopian tubes, preventing pregnancy. The scarring process takes three months. Women must use other contraceptives until testing confirms the tubes are blocked. Most often this test is not covered by insurance.

Over 19,790 have joined the Essure Problems Facebook group, because this contraceptive device that was supposed to be quick, easy and safe permanent birth control, has turned their bodies into a little house of horrors. Through May 2015, nearly 5,100 adverse event reports had been submitted to the FDA. The new study found the most common complaints include: pain, fatigue, abdominal distention, heavy menstrual bleeding, cramps, headache, abnormal weight gain, arthralgia, migraine, painful intercourse and hair loss.

Doctors tell us to rely on their knowledge and look askance at the Internet. However, device manufacturers can get FDA approval based on modest numbers with short term data. In the case of Essure, 400 women were followed for one year, and 200 for two years. There is difficulty in getting device illness reports taken seriously, especially when they are filed by patients, but doctors often do not file reports. There is a lag time for information to be collected, papers published and read, and information shared. Physicians who rely on the highest standards of evidence-based medicine will always be behind the curve.

We have both been injured by very different FDA-approved devices. Our symptoms escalated and cascaded, and our growing series of doctors and specialists could not find out what was wrong with us. At first they did not even consider that a device could be causing these systemic problems. Some were disbelieving as they had not read of reported cases of device illnesses in the literature. In each case, a great doctor helped figure out what went wrong, and we built new excellent medical (and dental) teams to work on addressing multiple and systemic problems.

Among the consequences: unable to work, impacts on our families, and high uncovered costs. Device illness patients face lives changing from a series of adventures, enjoyments and accomplishments to a series of medical appointments, medications and procedures.

According to the original Essure brochure given to women, the device should not be used in women who, “Have a known hypersensitivity or allergy to nickel as confirmed by skin test.” The brochure also stated (emphasis added): “There are very little data on the safety of or the chance of pregnancy with Essure beyond this time frame. Once longer-term data are available, the information on the safety of and chance of getting pregnant while using Essure may be different than the data based on 1 or 2 years of use.” By 2014, Bayer's updated brochure included additional warnings of pelvic pain, device migration, ectopic pregnancy, and allergy warnings.

Why does the FDA alert you to do a patch test for hair color 24 hours in advance, yet not require or recommend pretesting for biocompatibility (allergy and immune reactivity tests) before permanent devices are installed in non-emergency situations? Medical devices are not subject to the same type of premarket safety testing as prescription drugs. They have always been the poor stepchild of the FDA, and women, children and men who are unlucky enough to not be “average” pay a tragically high price. Metals allergies – and genetic variations in methylation – are not uncommon - but are rarely tested in advance.

Patients like us learn that our installed medical and dental devices were not “biocompatible” with our bodies, genes and cells after the fact, when it is too late. Historically, reporting of medical device health impacts – called adverse events by the FDA – has been done sporadically by doctors and rarely by patients. There is little incentive for research on post-market health problems – that arise after devices have been approved and are in widespread use. Nobody makes money on limiting uses of devices, vs. expanding their use.

Epidemico’s Medwatcher app empowers patients to report their health problems directly to the FDA quickly and easily, adding a new, direct experience database to document health impacts, and improvements from remediation that include operations to remove the device. Some patients have undergone multiple operations in efforts to contain and reverse the damage.

Many women will be going to an FDA Expert Panel Meeting on Essure September 24, 2015 – the day Pope Francis will be in town to address Congress. They will ask FDA to remove Essure from the market until further testing is done, or at a minimum issue a black box warning. Basically get this product off the market and find a remedy for those who have been harmed. Patients with other device illnesses – there are many – are submitting statements of support.

If you have any health problems whatsoever, look into whether a medical or dental device might be a factor in causing it. Do not be afraid to speak up when they think something is wrong. Only you know your body and nobody can tell you how you feel. Without your information, doctors and the FDA will be missing key impacts. If you have problems, report them on MedWatcher, so your experience can help support others’ health. Learn more, and tell FDA, the Administration and Congress to put patient safety and health first. Act now.

Melanie Goshgarian is a 911 Emergency Dispatcher with over 17 years of experience in police, fire, and medical emergencies. She volunteers as a patient advocate to Women harmed by Essure and collaborated with Epidemico on this MedWatcher study. Laura Henze Russell is Principal of Precision Research & Communications and Hidden River Health Challenge. She is launching a call for Medical and Dental Device Safety Urgent Reform: MEDDSURGE.