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

Here are the six slides I presented at the FDA Ob/Gyn Panel on Essure Sept. 24, 2015.

The testimony is on pages 173-175 of the FDA Hearing Transcript here. They asked a question about biocompatibility testing after my presentation.

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FDA’s medical device standards outdated, ineffective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.

Petition for Medical and Dental Device Safety Urgent Reform (MEDDSURGE)

Please sign this Petition to Congress & Administration: Medical & Dental Device Safety Urgent Reform (MEDDSURGE)

Many friends have been harmed from FDA approved medical and dental devices. 
The regulations are nearly four decades out of date. Fix them now.

Fix FDA regulations for medical devices and dental materials! Unlike for prescription drugs, 

OTCs, personal care and food products, there is NO information required to go to the 
patient or parent about materials they contain. Patients can experience harm from devices 
ranging from dental amalgam fillings to Essure, Mesh, joints, implants, stents and more. 
Reactions vary based on gene types that impact how well we clear materials that are not 
natural to the human body. There is NO pretesting to determine if you will have a reaction in
advance as is recommended for hair color (although a one-time test is available). Peer 
reviewed research links autoimmune, neurological and other illnesses with devices.

For dental fillings, there is NO right of written informed consent. FDA warnings for dental
amalgam (called silver fillings, but 50% mercury) are required only from manufacturer to 
dentist, NOT to patients. There is a flawed MedWatch reporting system for dental device 
reactions, and dental information does not go into patients' Electronic Medical Records so 
it is hard for doctors to connect illnesses. Dental insurance does not cover the higher cost of
replacing amalgam fillings when medically indicated. Patients face high costs and lost income.

Enact Medical and Dental Device Safety Urgent Reform (MEDDSURGE)! 

Refocus CDC and National Institutes of Health (NIH) funding on Chronic Diseases. Provide 

treatment for patients with device illnesses. Ask Surgeon General to take emergency action. 

Put patient safety first.

SIGN THE MEDDSURGE PETITION HERE

MEDDSURGE: Is Your Medical/Dental Device "Right for You?"

Medical and Dental Device Safety Urgent Regulatory Reform

MEDDSURGE: Top Priority for FDA Reform

Is Your Medical/Dental Device “Right for You”? Keep Pace with Science, Reduce Harm, Lower Costs

 For All Medical and Dental Devices, Congress should require:

·         Written information for patients on what materials devices contain, like for Rx & OTC.

·         One-time pretest to determine which devices are “right for you” in advance.

·         Immediate full implementation of the new system of Universal Device Indicators (UDIs).
·         Redirect device tax to Medical & Dental Device Illness Compensation (MEDDIC) Fund, and end federal preemption so ill and injured patients can seek redress in the courts.

Additionally for Dental Materials:

·         Written informed consent for dental fillings.

·         Medical records to include dental devices, fillings and materials information to allow physicians, epidemiologists and Big Data to assess the potential for health impacts.

·         FDA MedWatch Form 3500B to include a section tailored for dental fillings and devices.

·         Order HHS to release FDA January 2012 Safety Communication on Dental Amalgam.

Thousands of Patients Are Harmed by Medical and Dental Devices:

·         According to MedWatch & DENS, over 1,000 complaints have been filed on dental amalgam. Over 100,000 people have sought volunteer counseling from DAMS to find dentists qualified and able to work with patients ill from dental mercury toxicity.

·         FDA’s MAUDE shows thousands of women have filed complaints for medical devices such as Essure contraceptive coils, vaginal mesh, morcellators, and breast implants.

·         FDA’s MAUDE shows thousands of men and women have filed complaints for cardiac devices, implants, joints, stents, etc. If they are “right for you” is learned after the fact.

We Need Precision Medical and Dental Devices
MEDDSURGE Can Improve Health, Reduce Diseases and Lower Healthcare Costs By:

·         People react differently to foods, prescription drugs, and medical devices and materials.

·         Medical and dental devices provide 24/7/365 exposure to sources of inflammation.

·         Inflammation is at the root of many chronic diseases, from autoimmune to neurological.

·         Ensuring devices are ‘right for us’ will lower chronic disease rates and health care costs.

·         Tailoring medical devices selected for treatment to the characteristics of patients.

·         Conducting clinical trials run as “basket studies” by major genetic variants to determine which device materials are safer for which patients, and which should not be used.

·         Making sure any device used is “right for you” before it is installed.

·         Enabling patients to be reimbursed for uncovered medical, dental and supportive treatments by a Medical & Dental Device Illness Compensation (MEDDIC) Fund, and for patients to recover lost income and care expenses when needed.

Sign MEDDSURGE Petition here.