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Hundreds of Women Petition FDA on Essure


Posted in Regulatory and Compliance by mthibault on August 10, 2015

Hundreds of people have written to FDA, with most asking the agency to pull Bayer's Essure permanent birth control from the market.


Marie Thibault

 

 

Hundreds of people have sent comments to FDA petitioning against Bayer HealthCare's Essure permanent birth control system. Most of the comments are from women who were implanted with Essure and allege the device caused significant side effects. 

The public comments were sent in response to an FDA notice scheduling a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee for September 24. The panelists will discuss Essure, consider the risks and benefits based on scientific data, and make recommendations on future use, labeling, and, if necessary, any potential studies.

The Essure system, which Bayer acquired with its 2013 purchase of Conceptus, consists of nickel-titanium alloy inserts implanted hysteroscopically in a woman's fallopian tubes. Women undergo a confirmation test three months after implantation to ensure the fallopian tubes are blocked by tissue ingrowth around the inserts. Essure has had FDA approval since 2002. 

There have been more than 5000 complaints related to Essure submitted to FDA's Manufacturer and User Facility Device Experience (MAUDE) database between November 2002 and May 2015, according to FDA

Commenters give firsthand accounts of their troubles with Essure. Numerous women write about unexplained weight gain, pain, migraines, menstrual irregularities, and other complications, which started after Essure implantation. Some of the comments come from patients' loved ones, including sons, husbands, and cousins. One son writes that "I have seen Mother live everyday in pain and ER trips."

A Bayer spokesperson said in an e-mailed statement, "Bayer looks forward to an open and transparent discussion regarding Essure at the meeting of the Obstetrics and Gynecology Devices Panel on September 24, 2015. Bayer has been in regular communication with the FDA about the risk-benefit profile of Essure and the informational needs of both healthcare providers and patients.

"Patient safety is Bayer’s top priority. Given there has been a great deal of interest in the safety of Essure among some patients, we welcome this open dialogue with healthcare providers, patients, researchers, representatives from professional societies, and other members of the public to review and discuss available data regarding the benefits and risks associated with Essure.

"Bayer is strongly committed to women having access to safe and effective birth control options. The only FDA-approved non-surgical option for women who have completed their families and want permanent contraception, Essure is supported by more than a decade of science and real world clinical experience."

Catholic News Agency reported last month that a group of patients campaigning against Essure are planning a hunger strike outside the FDA building following the September 24 panel meeting. Pope Francis will be in Washington, DC the same day to address Congress, and the hunger strike is an attempt to ensure attention stays focused on FDA and Essure, as well as underscore the group's dedication to the cause, according to the article.

Enhance your medtech knowledge by attending MEDevice San Diego, September 1–2, 2015, in San Diego.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

[Image courtesy of OHMEGA1982/FREEDIGITALPHOTOS.NET]


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Comments to FDA conncerning nickel leaching fro Essure

On August 10, 2015 I have submitted comments to FDA regarding Essure problems and the way to fix them. However comments were restricted by FDA.

Comment from Ryszard Rokicki
Reason Restricted: This attachment is restricted to show metadata only because it contains personally identifiable information data
ID: FDA-2014-N-0736-0617
Tracking Number: 1jz-8khw-klei

I totally disagree with the reason of restriction, because my comments mention only already public knowledge as: patents, journal articles, Citizen Petition, and Open Letter to FDA Commissioner which was also previously restricted by FDA.
In my opinion this restriction tactic is not thy way for FDA to try to resolve serious health problems.

I would like to mention that my comments are partially supported by my article entitled "Detecting Nitinol Surface Inclusions" published February 2010 in this magazine.

Docket Id. FDA-2014-N-0736

My comments regard the nickel leaching from nitinol medical implanted devices, which could be the main culprit of medical problems of EssureTM –permanent birth control medical implanted device.
EssureTM micro insert consists of two coils of two dissimilar metals (inner coil made of stainless steel and outer self-expending coil made of nitinol) and polyethylene terephthalate fibers. All three materials are extensively used as implantable materials with rather good bio and hemocompatibility (stents, heart valves, IVC filters, micronet mesh-covered stent MGuard etc.).
However, one of those three materials, namely nitinol, the almost equitonic metallic compound of titanium and nickel, has a propensity to leach nickel to surrounding tissue when implanted. The amount of nickel leached to surrounding tissue depends on many factors: metallurgical homogenicity, quality of passive film covering the surface, chemical nature of surrounding body fluids and, most importantly, presence of intermetallic inclusions residing directly on the surface of implanted device. The 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. These surface intermetallic inclusions are the source of two main disadvantages of nitinol, namely source of nickel leaching and crack initiation sites, which could lead to a fracture of device.
Several years ago, after FDA issued warnings about nitinol IVC filter fracture, I filed a Citizen Petition (FDA-2009-P-0362) requiring FDA Commissioner to better protect patients who receive nitinol peripheral stents by issuing an order for mandatory inspection of every single nitinol peripheral stent for intermetallic inclusions before sterilization”. In the following months I amended my petition for nitinol heart valves, cardiovascular stent and IVC filters.
I proposed a simple, safe and cheap chemical test for detecting nitinol surface intermetallic inclusions on the surface of medical devices ready for implantation. This test allows for rejection of faulty devices before they are implanted.
Unfortunately for the people implanted with nitinol medical devices, the Citizen Petition FDA-2009-P-0362 was finally denied on May 19, 2011. The reason for denial was not the lack of merit of proposed test but FDA determination “that visually inspecting samples from Nitinol lots per ASTM F2063 will protect public health while not overburdening manufacturers of Nitinol products”.
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 removal of nickel hypersensitivity contraindication from EssureTM procedure Instruction For Use (“IFU”) in August 4, 2011 (5).
More astonishingly, on March 8-9, 2012 FDA held a Public Workshop – “Cardiovascular Metallic Implants: Corrosion, Surface Characterization, and Nickel Leaching”.
After my registration to participate as discussant was rejected, I wrote Open Letter to FDA offering my help to resolve problems of nickel leaching from nitinol implantable devices after implantation.
After a year of not finding my Open Letter on Docket No. FDA-2012-N-0057-0001, I wrote to FDA to ask about it. After my inquiry, my letter to FDA was mentioned on July 2, 2013 but it was not published on regulation.gov webpage as per annotation: ”Reason Restricted: This attachment is restricted to show metadata only because it contains personally identifiable information data”.
It is unfortunate that my Citizen Petition was denied and my Open Letter was not taken under consideration.
However, after reading the latest article published in Journal of the Mechanical Behavior of Biomedical Materials, coauthored, among others, by three FDA researchers: S. Gupta, J.D. Weaver and S. Nagaraja and sponsored by FDA, entitled “High compressive pre-strain reduce the bending fatigue life of nitinol wire”(6), I have hope that FDA will take another look at the importance of eliminating nitinol implantable medical devices and arthroscopic nitinol tools with surface intermetallic inclusions, and by this preventing nickel leaching and unexpected fractures.
My hope comes from the article itself, which repeatedly mentions intermetallic inclusions as crack initiation sites (which are intrinsically connected with phenomenon of nickel leaching) e.g. “cracks initiated from surface inclusions in nearly all wires”.
Considering that FDA researchers themselves confirmed the inferiority of nitinol with surface intermetallic inclusions and given the fact that a very simple test-procedure can find and eliminate faulty devices, it would be an act of pure travesty on behalf of FDA not to mandate the use of the test.
It is high time for FDA to revisit my Citizen Petition Docket No. FDA-2009-P-0362 and seriously consider my Open Letter FDA-2012-N-0057-0001 and publish it in non-restricted form. FDA should undertake internal tests by FDA to prove, validate and implement test –procedure for detecting surface intermetallic inclusion mentioned in my Citizen Petition and Open Letter for all bare-metal nitinol implantable medical devices and arthroscopic tools.
The decision by FDA to mandate the test will save countless lives, prevent medical complications and patient suffering, and result in billion dollar savings in medical cost.
References:
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 electropolished and magnetoelectropolished nitinol surfaces.” April 28, 2015
5. Remove Nickel Contraindication From the Essure Procedure Instructions. Mountain View Calif., Aug. 4, 2011(GLOBE NIEWSWIRE_ - Conceptus, Inc. C:\Users\Owner\Documents\Essure\Conceptus(R) Announces FDA Approval to Remove Nickel Contraindication From the Conceptus ® Announces FDA Approval to Essure Procedure Instructions NasdaqCPTS.htm
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.

Ryszard Rokicki August 10, 2015
5657 Fox Ln
Emmaus, PA 18049
Phone (610) 967-5800