MAKING ESSURE SAFE
After FDA denied my Citizen Petition and restriced from public view my Open Letter to FDA Commissioner and most recently my comments concerning safety of Essure, FDA should be well aware what causing the Essure problems and how to correct them.
In my opinion there are only two ways to resolve the sometimes-sever medical problems connected to Essure: totally ban it or make it safe.
To make it safe the faulty nitinol material (outer coil) with surface intermetallic inclusions should be detected and discarded before the device is assembled.
The only way to achieved this is to use very simple, cheap and 100% reliable chemical test for detection of nitinol surface intermetallic inclusions.
The uniform nickel leaching from properly finished nitinol without surface intermetallic inclusions, even if galvanically coupled to another metal as in case of Essure, is of negligible importance.
However, nitinol surface inclusions or adjacent matrices are source of catastrophic nickel leaching to surrounding tissue after implantation.
Somebody can ask why we don’t hear similar complaints from people implanted with other kind of nitinol medical devices such as stents heart valves etc. The answer is place of implantation. Stents, heart valves are vascular devices permanently exposed to blood flow and therefore nickel leached from surface inclusions or surrounding matrix is carried away and eventually leaves human organism with urine.
However we have totally different situation with Essure, which is permanently embedded in the tissue of fallopian tube. In this case leached nickel from surface inclusion or adjacent matrix stay and accumulate in tissue which is in direct contact with leakage.
Given the severely detrimental effect of nitinol surface inclusions, it is obvious that devices which contain them should be discarded before implantation.
As present checking nitinol medical devices for surface intermetallic inclusions is governed by ASTM F2063 test which is performed by visually inspecting samples from nitinol lots.
This test was a reason given by FDA for denying my Citizen Petition, which demanded the introduction of more reliable (100% proof) sodium hypochlorite test-procedure.
The FDA stated: “that visually inspecting samples from nitinol lots per ASTM F2063 will protect public health while not overburdening manufacturers of nitinol products”.
However the problems with Essure contradict the FDAs statement and clearly show that visual inspection wasn’t enough for more than 5000 women who reported severe problems caused by Essure to FDA.
To prove my point, I advise the FDA to collect explanted devices and check them for traces of pitting, cracks and corrosion products on the surface of outer nitinol coil of Essure device.
Safety of Essure device is now in hands of FDA.
MAKING ESSURE SAFE
In my opinion there are only two ways to resolve the sometimes-severe problems connected to Essure: totally ban it or make it safe. To make it safe the faulty nitinol material (outer coil) with surface intermetallic inclusion should be detected and discarded before assembling the device. The only way to achieve this is to use very simple, cheap, and 100% reliable chemical test for detection of nitinol surface intermetallic inclusions.
Most probably the main reason for Essure’s medical problems is nickel leaching from the outer nitinol coil of the device. The use of nitinol as material of the outer coil of the device is dictated by its remarkable shape memory properties, which in this case enables the device to be anchored in the required position in the fallopian tube. However, nitinol, the almost equiatonic metallic compound of titanium and nickel, has a propensity to leach nickel to surrounding tissue when implanted. The amount of nickel leaching to surrounding tissue depends on many factors: metallurgical homogeneity, the quality of passive layer covering the surface, the chemical nature of surrounding body fluids and most importantly the presence of intermetallic inclusions residing directly on the surface of implanted device. Intermetallic inclusions are intrinsically tied with nitinol (1, 2, 3, 4) and finding them on the surface of a finished medical device ready for implantation is pure luck. The nickel leaching from properly finished nitinol implanted device without the presence of surface intermetallic inclusions is minimal and does not cause medical problems in most cases. Also, galvanic corrosion, which in the case of implanted Essure device arises from the use of two different metals (stainless steel inner coil and nitinol outer coil), is of negligible importance (5).
However, nitinol surface intermetallic inclusions are the biggest sources of nickel leaching from nitinol which should be reckoned with.
Somebody can ask why we don’t hear similar complaints from people implanted with other kinds of nitinol medical devices such as stents, heart valves, IVC filters, etc. The answer is the place of implantation. Stents, heart valves, etc. are vascular devices permanently exposed to blood flow and therefore nickel leached from surface inclusion or surrounding matrix is carried away and eventually leaves human organism with urine. This doesn’t mean that such devices didn’t have surface intermetallic inclusions. In these cases nickel leaching most probably speeds up stent restenosis and compromises the mechanical integrity of devices, which could lead to device fracture. But in vascular cases the complications from nickel leaching do not produce the same symptoms as in the case of Essure (pain, constitutional symptoms, etc.). However we have totally different situation with Essure, which is permanently embedded in the tissue of fallopian tube. In this case leached nickel from surface inclusions stays and accumulates in tissue which is in direct contact with leakage.
Given the detrimental effect of nitinol surface intermetallic inclusions, it is obvious that devices which contain them should be discarded before implantation.
At present, checking nitinol medical devices for surface intermetallic inclusions is governed by ASTM F2063 test which is performed by visually inspecting samples from nitinol lots.
This test was the reason given by FDA for denying Citizen Petition Docket No. FDA-2009-P-0362, which demanded the introduction of a more reliable (100% proof)) sodium hypochlorite test-procedure (2, 4).
The FDA stated “that visually inspecting samples from nitinol lots per ASTM F2063 will protect public health while not overburdening manufacturers of Nitinol product”.
However, the problems with Essure contradict the FDA’s statement and clearly show that visual inspection wasn’t enough for more than 5000 women who reported severe problems cause by Essure to FDA.
The importance of finding and discarding nitinol implantable medical devices with surface intermetallic inclusions before implantation was highlighted by a recent article (6) coauthored, among others, by three FDA researchers and supported by FDA Commissioner’s Fellowship Program.
The article states that “crack initiated from surface inclusion in nearly all wire”. Please note that nitinol surface intermetallic inclusions mentioned as crack initiation sites are intrinsically connected with phenomenon of nickel leaching after device implantation.
Also, I would like to comment on FDA restriction tactics on invited comments and Open Letters, which were applied in my case two times. First, in 2013 my Open Letter to FDA Commissioner offering my help to resolve problems of nickel leaching from implantable devices after implantation Docket No. FDA-2012-N-0057-0001 was restricted from public view. Secondly, restriction was applied to my comments regarding Essure FDA-2014-N-0736-617. The reason given for restriction was “personally identifiable information data”.
I totally disagree with the reason for restriction, because the comments mentioned are already public knowledge such as: patents, journal articles, Citizen Petition, and an Open Letter to FDA Commissioner.
I think that this restriction tactic is not the way for FDA to try to resolve serious medical problems.
I would like to advise the FDA to remove the restrictions and publish my Open Letter and Essure comments, which I believe can improve the understanding of the importance of nitinol surface intermetallic inclusions of nitinol implanted medical devices.
In conclusion, given patient complaints and safety problems, Essure device in its present state should be banned.
However, by applying a sodium hypochlorite test-procedure to every single nitinol outer coil before assembling the device and discarding the coils which positively test for surface intermetallic inclusion, the safety of Essure device could be highly improved by eliminating nickel leaching problems.
To prove my point, I advise the FDA to collect explanted devices and check them for traces of pitting, cracks, voids and corrosion products in the form of deposit on outer nitinol coil of Essure device.
1. R. Rokicki, “Detecting nitinol surface inclusions”. Medical Device & Diagnostic Industry, February 1, 2010, Volume 32, No. 2, pp 44-48
2. R. Rokicki, US Patent 8377237 “Method for surface inclusions detection in nitinol which are primary corrosion and fatigue initiation sites and indicators of overall quality of nitinol material.” February 19, 2013
3. R. Rokicki, T. Hryniewicz, C. Pulletkurthi, K. Rokosz, N. Munroe, “Towards a better corrosion resistance and biocompatibility improvement of nitinol medical devices” Journal of Material Engineering ad Performance, April 2015, Vol. 24, Issue 4, pp 1634-1640, DOI:10.1007/s11660-015-1429-x Published on line 18 February, 2015
4. R. Rokicki, US Patent 9017489 “Method for surface inclusions detection, enhancement of endothelial and osteoblast cells adhesion and proliferation, sterilization of electro polished and magnetoelectropolished nitinol surfaces.” April 28, 2015
5. A. Kazimierczak, W. Podraza, S. Lenart, I. Wiernicki, P. Gutowski, “Electrical potentials between stent-grafts made from different metals induce negligible corrosion.” Eur J Vasc Endovasc Surg. 2013 Oct; 46(4):432-7. Doi: 10. 1016/j.ejvs.2013.06.010. Epub 2013 Jul 16
6. S. Gupta, A.R. Pelton, J.D. Weaver, Xiao-Yan Gong, S. Nagaraja, “High compressive pre-strains reduce the bending fatigue life of nitinol wire”. Journal of the Mechanical Behavior of Biomedical Materials 44 (2015) 96-108.
Email: [email protected]
Below is my Open Letter to Bayer Chairman. I wonder if he will reply.
OPEN LETTER TO THE CHAIRMAN OF THE BAYER COMPANY CONCERNING ESSURE SAFETY
I am writing this letter as public speaker No. 32 at Obstetrics and Gynecology Device Panel Medical Devices Advisory Committee Meeting, which took place September 24, 2015 in FDA headquarters.
I am sure you watched the video and read heart-braking testimony of women who suffer medical and mental problems due to Essure implants.
I am not in a position to question efficacy of Essure device because I am not a medical doctor.
However, with 30 years of experience in the metal finishing field, including finishing nitinol medical devices, I can question the quality of the finish of metal components, especially the outer nitinol coil of the Essure device presented by speaker No. 33. The micrographs of nitinol ribbon of outer coil of the device have not resembled the finish expected from medical implantable device. They showed cracks, voids, intermetallic inclusions, which should not appear on surface of implantable device.
I was very disappointed that panelists completely ignored my and speaker No. 33’s suggestions concerning the finish of nitinol outer coil of Essure device.
I would like to repeat again what I said in my speech that the main problem of Essure device is catastrophic nickel leaching from nitinol surface intermetallic inclusions or from adjacent matrix, which could be very easily corrected.
The recommendations made by FDA committee do not even mention the problem of nitinol outer coil finish.
Now I would like to tell you my personal story, which relates to the Bayer Company’s image.
Ten years ago I had a heart attack and underwent quintuple by-pass surgery. When I was discharged from the hospital the doctor prescribed for me baby Aspirin (81mg) to be taken for the rest of my life. When I went to buy medication at a pharmacy, my hand involuntary grabbed Bayer Aspirin even though it was the most expensive brand. The explanation for this involuntary reflex is the imprint on my memory from my childhood where in our medicine cabinet the Bayer Aspirin was present.
I think that for most people in the world the word Aspirin is immediately associated with the Bayer Company.
However, after seeing the micrographs presented by speaker No. 33 of nitinol outer coil of Essure device next time I buy Aspirin I will have second thoughts about which brand to buy.
I am writing to you because it is within your power to order that the quality of nitinol outer coil of Essure device be improved and consequently most of Essure safety problems resolved.
Do not let me switch the Aspirin brand.
THE TRUE REASON WHY THE FDA RESTRICTED MY COMMENTS CONCERNING THE SAFETY OF ESSURE FROM PUBLIC VIEW
On August 10, 2015 I filed my comments concerning the safety of Essure to the FDA. The next day after opening the FDA Docket I found the following note about my comments:
Reason Restricted:This attachment is restricted to show metadata only because it contains personally identifiable information data.
I was not surprised to see this absurd note, because the same happened to me when I filed my Open Letter to the FDA Commissioner to offer my help to resolve the serious problem of catastrophic nickel leaching from faulty nitinol products in 2012.
I called the FDA explanation to justify the restriction of my comments absurd, because they contained information which is already public knowledge such as: patents, journal articles, a Citizen Petition, and an Open Letter to the FDA Commissioner and the fact that they are signed by me, which is obvious when you file non anonymously.
However in my opinion the true reason for restriction of my comments by FDA is to prevent embarrassing themselves by the decision which they made in 2011: namely, Approval to Remove Nickel Contraindication from the Essure Procedure Instruction ( at that time Essure was still owned by Conceptus).
As I stated in my restricted comments: “The FDA decision to deny Citizen Petition Docket No. FDA-2009-P-0362 from May 19, 2009 on May 19, 2011 was almost immediately followed by FDA approval of the removal of nickel hypersensitivity contraindication from Essure™ procedure Instruction For Use (“IFU”) on August 4, 2011“.
I would like to remind the readers that the reason for denying the petition given by the FDA was not the merit of the proposed test-procedure but concern for not overburdening the manufacturer of nitinol products.
The label change which eliminated the nickel hypersensitivity warning in my opinion was a magnet for women which before may have had second thoughts about deciding on an Essure implantation procedure.
The Conceptus statement from August 4, 2011reads as follows: “The label change expands the number of potential patients for Essure, and is supported by nearly a decade of commercial use and data gathered from the Essure clinical trials that demonstrate no causal relationship between nickel sensitivity and wearing the Essure micro-insert.”
Now somebody could ask if the FDA decision was done purposely to lure more women to decide to use an Essure implant or not; the answer to this question I leave to the reader. However the decision for the approval of removal of nickel hypersensitivity contraindication from Essure was total unprofessional on behalf of the FDA.
I also would like to mention a second potential embarrassment for FDA mentioned in my restricted comments: namely, totally ignoring the research done by their own researchers regarding the importance of nitinol surface intermetallic inclusions in the safety of nitinol.
As I stated in my Open Letter to Bayer Chairmen published on “Essure Problems:
“I was very disappointed that panelists completely ignored my and speaker No. 33’s suggestions concerning the finish of nitinol outer coil of Essure device.
I would like to repeat again what I said in my speech that the main problem of Essure device is catastrophic nickel leaching from nitinol surface intermetallic inclusions or from adjacent matrix, which could be very easily corrected.”
Somebody could ask why tax payer money should support research, which is not even taken under consideration by their own sponsors to try to resolve very serious medical health problems. This is really mind boggling.
The panel recommendation about changing the labeling etc. without even trying to determine the real cause of the safety problems sounds like humor from a cheap horror movie.
It is my belief that if FDA prioritized patients’ safety over protecting industry and my Citizen Petition from 2009 had been approved that time we would not hear women complain from the time of making this test mandatory.
Concluding, I would like to repeat my opinion how to resolve Essure safety problems: ban it totally or make it safe.