Table of Contents
Proposal: FDA Independant Study ~ requesting they fund an independent study of the tissue samples surrounding essure coils.
Surgery File/Survey Information Essure Problems Group
Pregnancy File/Survey Essure Problems Group
Pathology Report Data
Clinical Trial Participant Data
Fetal death, Miscarriage, Ectopic, Spontaneous Abortions in Maude Database
Doctor Letters: Number of surgeries for essure removal and common findings
Mark Bell Powerpoint
William Maisel [email protected]
Aron Yustein [email protected]
Marsha Henderson [email protected]
Joyce Whang [email protected]
Benjamin Fisher [email protected]
Marjorie Jenkins [email protected]
Kimberly A. Thomas [email protected]
James Saviola [email protected]
Shanika Craig [email protected]hhs.gov
It was a pleasure meeting with you and other FDA members last week and we truly appreciate the opportunity to discuss our significant concerns regarding Essure. The FDA is responsible for protecting the public health by assuring the safety and efficacy of medical devices and acts as the gatekeeper ensuring certain safety standards are met for medical products. As you are aware the Essure Problems Group strongly believes the Essure device is both unsafe and ineffective. Our group has over 27,000 members and is growing daily at an exponential rate. Suffice it to say, this group is tenacious and is resolute in its goal of having Essure removed from the market or ensuring that every potential patient unquestionably understands the full ramifications and dangers of having the Essure implanted.
At the meeting, we discussed the FDA funding independent research and testing of the tissue surrounding the explanted coils. We believe it imperative that extensive testing be performed both on the composition and degradation of the coils themselves as well as on a radius of surrounding tissue and pathology explanted with the device. This testing is necessary to examine the materials leaching into the surrounding tissue and to identify the source, i.e., whether it is degradation of material from the PET fiber, metal alloys and/or the hydrophilic and/or hydrophobic coatings peeling and separating. We feel the FDA with its vast resources and pool of independent scientists and physicians is in the best position to undertake this study. It is not uncommon for the FDA to fund studies by 3rd. party “unbiased” entities.
If the FDA undertakes the study, we can provide the explanted coils and pathology as long as the information and results of the study are made available to us. We would also request that the identity and results of each individual patient’s tissue studied be retained, although it may be redacted or blinded during the study. We are happy to discuss the parameters of the study and work out an agreeable protocol.
In short, we appreciate the continued dialogue and we are willing to assist your efforts in protecting the public health regarding Essure. We are gathering the substantial data discussed at the meeting and expect to have this information to you in the next two weeks. In the interim, should you have any questions or need any assistance or other data we may not have discussed, please do not hesitate to contact us.
Summary of Surgical Data
February 19, 2016
To Whom It May Concern;
Attached you will find a spreadsheet, the purpose is to show a very small sample of pathology reports of women who required surgery to remove the Essure devices. On the right hand side are some comments from the reports on how the devices are identified. It has been a concern that so many women had reported that the devices were not included in their reports, many other women reporting that the pathologist did not know what they were and therefore, identified them as such you will see in this sample. Names have been purposely omitted to protect privacy HIPPA. Several reports here do not have an age or date of birth.
This is not a research study but, a glimpse at a further concern of why Essure should not be on the market. The same was been said of Radiologists, when women have gone for Ultrasounds, MRI’s, CT. Scans and even HSG’s. Furthermore, often perforations and migrated coils do not show but, often discovered upon removal of Essure and the organs the coils have perforated. Perforations and migration of devices is very painful.
Never thought it was possible for the FDA to give a permanent medical device PMA status and the medical community at large who would potentially come in contact with these implanted women wouldn’t know what ESSURE was. Emergency rooms throughout, this country do not know what Essure is. Women show up in distress, pain and extreme bleeding in some cases. Often explaining to doctors, nurses and technician’s what Essure is. Many are turned away without any answers, referred back to their Gyn’s who further victimize them by often saying the devices are not causing these issues.
In September 2014 a letter was sent to the American College of Radiology www.acr.org and another letter sent to College of American Pathologist www.cap.org. Attached are the two letters for your review. The hope and desire then and still is, was to bring awareness to this ongoing pattern of lack of knowledge into these medical devices. No reply or acknowledgement was received.
It is concerning that women continue to be harmed by these devices when there is obvious disregard for women’s health. If radiologists, doctors (PCP’s) and pathologists do not know what these devices are, women are potentially not receiving appropriate medical treatment and care. This is to also include many other specialists as well.
Thank you for taking the time to review the attached documents.
Essure Problems Admin Team
Lisa Saenz, LMSW
Elena Mendez, RN, CARN
Pregnancy Survey Essure Problems
We have had 607 women report pregnancy to us.
318 reported miscarriage. Of those 318, 16 were ectopic.
11 had abortions
208 were live births (8 sets of twins 1 set of triplets)
112 were still pregnant at time of filling out survey
44 left unknown outcome
9 reported fetal death beyond 24 weeks or stillbirth
Essure Clinical Trial Participants
Below are a sample of the women from the original clinical trials for Essure who have been adversely affected by the device. We have all of their stories, all of our conversations with them, and all of their health information. I can summarize by saying their experiences within the clinical trials were all very similar. Almost every single patient was told that the implant was 100% surgical steel. Nickel was never mentioned to them, nor were the polyethylene terephthalate (PET) fibers. Most experienced pain and adverse events after being implanted with Essure. Most (nearly all) of those experiences were dismissed as not being related to the device. Many patients were dismissed from the trials early. The few for whom we have retrieved trial records all show alterations of the data. Most participants said that they were coached on how to answer the questionnaires. At this time, we will not share our private conversations with them to protect their privacy, and we will not include all of that data nor their records. However, if the FDA wishes to reach out to any of these women and ask permission to view that data, we can arrange contact with these women.Original trials
Kim Hudak Cleveland Clinic- Dr Bradley (altered records)
Barb Musallami O'dell
Gabriella Avina- Dr Gallen
Crystal Brown Greenville SC-Dr Thomas Price and Dr John Nichols (Dr Paul Miller)
Kimberly Lira Huddleston 2000 23 yrs old-Dr Cooper (altered records)
Patricia Rhodes 2000 Arizona Women's Health Research-Dr Cooper (altered records)
Melissa Knight 2000-Dr Cooper
Brenda Rene Snell maiden name Shaabe
Dusti Hargrove Braschler
Janette Lenk -Dr. David Levine out of St. Luke's Hospital in St. Louis.
Diane Dyer Leeds
Caroline Rodgers- Stop device - in Leeds England St.James Hospital David Beavers clinic.
Jan Nelson- Stop device- Professor John Kerin 2000 Adelaide Australia.
Jennifer Marshall- Melbourne Australia
Jacki Thomas- experimental stage- Bungaree Australia
Georgina Fry Australia-Dr Kerin
Sue Morris Australia-Dr Kerin (Susan Winchester)
Shelly O'Mally Ashford hospital in SA
The following list of women have been participants in Essure trials after approval. All of these women joined our group because they were having adverse events from Essure. Again, we have all of their posts to the page, conversations we've held with these women, etc.
Janette Collins was assigned to speak with Corina Campbell and Katie Morrow. After contact was made via email and one phone call, no more contact was made. After the recent meeting held at the FDA with members from our group, Janette reached out to Corina again, asking for information she was already given. Corina may or may not respond, as she has lost her job, and she and her children were evicted from their home; she is now too sick to work and cannot pay the bills.
Of the other post-market trial participants, one, Victoria Williams, became pregnant during the trials. Her placenta and breast milk both tested high for nickel content.
Heather Ralston was a participant in the ESS505 trial. While under sedation, the doctor could not place the ESS505, so he aborted that procedure and decided to implant her with the ESS305 instead. This was done without her knowledge and without her consent. She only recently found out as we instructed her to find out why she was dismissed from the trials and to start obtaining her medical records.
There are significant failures to record accurate experiences across the board with Essure clinical trials. We strongly believe the manufacturer is not presenting accurate findings to the FDA regarding the safety and efficacy of Essure. Their trials appear to be constructed and conducted in a manner which includes a built-in confirmation bias; “problem” patients are dismissed and the remaining are coached on giving “positive” feedback about the device. These are serious issues which should be investigated.
Amanda Garmon ess505
Deidra Carver hydrogel
Kelley Konitzer Messer hydrogel
Corina Campbell- Essure (Model ESS310) Placement Rate Study. Implanted 9-24-14, tube/coil removal 10-29-14 dismissed from trials
Victoria Williams pregnant irb#11-00631300 had baby. high levels of nickel in placenta and breast milk
Heather Ralston ESS505 couldn't place ESS505, aborted and placed 305 without consent or knowledge, dismissed from trials