REPEAL THE BIOMATERIALS ACCESS ASSURANCE ACT OF '98
REPEAL THE BIOMATERIALS ACCESS ASSURANCE ACT OF '98
We, the undersigned, call on the United States House of Representatives to consider repealing the Biomaterials Access Assurance Act of 1998 and hold any supplier of raw material such as Dacron, Polytetrafluoroethylene (Teflon), and Polypropylene liable if they knowingly provide said material to a medical device company that does not intend to use the material to manufacture a medically necessary life saving device. While it is understood that there is really no way to track how these materials are being used, better regulation and research must be completed in order to eliminate the possibility of these toxic materials misuse. If there proves to be no way to account for the materials use, then the material need not be sold to the medical device company.
We trust that it is our right as United States Citizens to assume the safety of materials used in devices such as the fibers in Essure permanent birth control and Transvaginal Mesh procedures, have been thoroughly tested and proven safe without biased prior to FDA approval. Sadly, this is not the case.
In fact, these materials come with a warning...
First please watch these brief videos to get an understanding of how textiles/fibers used in Essure and Mesh are materialized. They are pure plastic chemical garbage!
The following all ties together how those plastic fibers/textiles ravished and ruined hundreds of thousands of lives. I’m not just talking about the patients implanted with the Essure sterilization device or Mesh, but their loved ones have been horribly affected as well.
The Essure™ Permanent Birth Control System consists of two microinserts comprising a dynamic outer coil (nickel titanium alloy) within which is contained a flexible inner coil (stainless steel) along and through which runs a layer of polyethylene terephthalate (PET, Dacron®; Meadox Medical Inc., Oakland, NJ, USA) fibers.
Meadox Medical Inc
http://www.nytimes.com/1995/09/30/business/company-news-boston-scientific-near-meadox-takeover.html?smid=pl-share Meadox Medical merges with Boston Scientific in 1995... a year and a half before they merged with Target Therapeutics. http://www.nytimes.com/1997/01/21/business/boston-scientific-to-acquire-specialized-catheter-maker.htm Target developed the catheters for Essure, which are also made from polymers (plastic) and spun off ( http://bit.ly/17iBemh) to form a new company called Conceptus Inc. They were the original manufacturer of Essure before it was purchased by Bayer in 2013.
http://www.drugwatch.com/manufacturer/boston-scientific/ Boston Scientific is currently staring down thousands of lawsuits from women who claim to have suffered injuries related to the company’s transvaginal mesh products, which are used to treat pelvic organ prolapse and incontinence issues.
Relevant Side Note: Former F.D.A. Chief Is Charged With Conflict
http://www.nytimes.com/2006/10/17/washington/17fda.html?_r=0 Senior employees of the food and drug agency are prohibited from owning shares in companies the agency regulates, and when Dr. Crawford became a deputy commissioner in 2002, the government’s charging document says, ethics officials at the Department of Health and Human Services told him that he and his wife would have to sell stock in a dozen regulated companies. Those companies included several large pharmaceutical and medical device concerns, among them Johnson & Johnson, Merck, Pfizer, Medtronic and Boston Scientific.
Meadox Medical was Purchased from Boston Scientific by Maquet/Atrium in 2008; http://prn.to/1AXl26b MAQUET Cardiovascular's history in New Jersey started with Meadox Medical, which was founded in Haledon in 1954. Meadox was acquired by Boston Scientific Corporation in 1995. In 2008, MAQUET acquired the Meadox business and the former Guidant cardiovascular surgery business from Boston Scientific, and formed MAQUET Cardiovascular. In 2009, the company acquired Datascope, another New Jersey- based medical device company, and emerged as a leading global provider of the top-selling cardiac and vascular surgery products on the market today.
Warning Letter from the FDA to Maquet in 2010: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225051.htm This warning subsequently resulted in several recalls involving vascular grafts made from polymer textiles.
History of Meadox
Ormond Julian of Chicago and Ralph Deterling of New York collaborated with William von Liebig, the general manager of Meadox Weaving Corporation, an upholstery and drapery fabric manufacturer in New Jersey, to design and produce fabric grafts. Of that period, Deterling somewhat irreverently declared: “It seemed almost heretical that the introduction of cloth as a vascular replacement allowed people with practically no background in the field to go to Macy's and ask a clerk, ‘What's the best thing for an aorta?'” He also astutely observed: “The aggressiveness of the vascular surgeon is a tremendously important thing. The willingness at the end of a hard day to go back and repair a graft if it shows early failure is something that separates the men from the boys.” From their beginnings in 1954, the first woven grafts manufactured by Meadox were distributed by the Ethicon Division of Johnson & Johnson. By 1961, William von Liebig emerged as the new owner, and Meadox Medical, Inc., was launched, later to team also with Denton Cooley in production of the graft line that carries his name. Liebig credited erstwhile associate Walter Golaski of Philadelphia for a number of important technical developments during the start-up phase of Meadox grafts. Emerick Szilagyi, working first with John Sidebotham of Philadelphia, and later with Meadox, produced a woven Dacron graft of specially elasticized yarn that proved to be highly porous but quite efficacious, providing 97% patency at 3 to 5 years after implantation of 286 aortoiliac grafts. http://www.jvascsurg.org/article/S0741-5214(98)70286-1/fulltext A variety of other prosthetic materials and fabrications were tried in those early years. Norman Shumway et al. of Minneapolis experimented with rolled sheets of polyvinyl sponge (Ivalon), and Shumacker and colleagues of Indianapolis used layered nylon, incorporating a thin polyethylene film to provide hemostasis. Allan Callow of Boston called attention to the need for better control of the manufacturing process of vascular grafts, while Sterling Edwards warned that it was not feasible to continue to tailor-make grafts—the industry had to develop adequately tested, prefabricated tubes in a variety of shapes and sizes. Deterling and Bhonslay of New York summarized physical and chemical data as well as in vivo experiments on a wide range of fabrics in 1955, concluding that “...Dacron appeared to have the most desirable qualities in the overall evaluation.”Dacron, a polyester polymer developed about 1939, had been introduced in the United States by E. I. DuPont de Nemours and Company, Inc., in 1946 and was adapted to vascular applications 8 years later.85 It consisted of a basic 70-denier yarn, 54 filaments to the strand, texturized to provide bulk and elasticity. In a report to the Society for Vascular Surgery meeting in 1956, Oscar Creech, Chairman of a Committee for the Study of Vascular Prostheses, concluded that Dacron and Teflon were the most satisfactory materials for use at that time, because Vinyon-N was no longer commercially available and because both nylon and Orlon exhibited significant loss of tensile strength over time.(So this ties DuPont and Dacron into Meadox)
"In closing, allow me to mention one cautionary note. Just when vascular surgeons had become comfortable with the durability and availability of Dacron prostheses, we were shocked to hear that the future supply of the raw material is threatened. Dupont, the solitary source of Dacron for 50 years, has withdrawn the textile from medical use as a result of product liability issues. Although the graft applications of Dacron appear to have constituted only a small fraction of Dupont's total market, inordinate business expenses for legal defense of the material were cited as the rationale for withdrawing the product. It is said that the major graft makers presently have only a 3-year stockpile of Dacron yarn with which to continue to manufacture grafts. At that point, they will have to switch to alternate sources of polyester. We have been assured by the industry, however, that other raw material sources have been identified and that surgeons will not discern any difference in the quality of the new grafts. One can only hope that their predictions are true. Meanwhile, an agency called The Alliance of Patients, Physicians, and Industry for Access to Medical Devices has urged Congress to address biomaterials shortages and other related tort reform issues. As you know, biomaterials legislation was incorporated into a broader product liability bill that was passed by Congress last year but vetoed by the President. With the current Congress, the Biomaterials Access Assurance Act has been redrafted by Representative George W. Gekas (R-Pa.). The surgical community remains hopeful that for the benefit of our patients acceptable legislation will pass and be enacted."
IMPLANT INDUSTRY IS FACING CUTBACK BY TOP SUPPLIERS
Published: April 25, 1994
“In the past, companies like Du Pont have made products like Dacron polyester, Delrin polyacetal resin and Teflon polytetrafluoroethylene fiber and resins available to medical companies accompanied by warnings that they had not been tested in any way to establish their suitability for medical applications. (Dacron polyester is the trade name for polyethylene terephthalate. If you watched the video above you know to make them into fibers you have to create a liquid polymer. The two main derivatives or chemicals in Dacron is terephthalic acid and ethylene glycol. Ethylene glycol is the main ingredient in anti-freeze)
ACCESS ASSURANCE ACT OF 1998 http://www.gpo.gov/fdsys/pkg/PLAW-105publ230/pdf/PLAW-105publ230.pdf
http://commdocs.house.gov/committees/judiciary/hju44196.000/hju44196_0.htm BIOMATERIALS ACCESS ASSURANCE ACT OF 1997 "And for the sake of those who do not know exactly what the bill does, it simply provides a mechanism whereby the supplier of generic materials, materials that can be used for a million different purposes, are ordered and bought by a company that is engaging in the business of creating new medical devices and putting materials together for lifesaving purposes in many cases. The supplier innocently sells a batch of these materials and then finds that it, the supplier, is subjected to voluminous suits both in dollars and in time and energy that would be visited upon them, because something along the line may have gone wrong and the patient, within the rights of that patient, brings a legal liability suit."
https://www.govtrack.us/congress/bills/105/s966 This bill was sponsored by Senator John Breaux. After his congressional career, Beaux went on to become a lobbyist, co-founding the Breaux-Loft leadership group. The firm later was aquired and merged with law and lobbying firm Patton Boggs. Patton Boggs is a known lobbiest for the original manufacturer of Essure, Conceptus Inc!! http://www.opensecrets.org/lobby/client_reports.php?id=D000067184&year=2004 ;
Beaux campaign contributions from DuPont http://influenceexplorer.com/organization/dupont-co/61617ca172cd44f586328cfd7a67f44a?cycle=1998
Here is the MSDS sheet for Dacron
MEDICAL USE: CAUTION: Do not use DuPont materials in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues. Do not use DuPont materials in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from DuPont under a contract which expressly acknowledges the contemplated use. For other medical applications, see DuPont Caution Bulletin No. H-50102.
Here is an exerpt from a resent trial involving Mesh;
"For example, Frank Zakrzewski, the Chevron Phillips employee designated to testify regarding the Phillips Sumika4 Marlex material safety data sheet (“MSDS”), testified that Phillips Sumika does not have any medical device expertise. (Zakrzewski Tr. at 173:13-15.) These companies do not assess the propriety of using their materials in finished medical devices. As Mr. Zakrzewski repeatedly testified, Chevron Phillips and Phillips Sumika do not determine whether the resin is suitable for a particular use, but rather, expect the end users of its Marlex resin to make this determination. (Id. at 75:1-8; 168:20-169:14.) Nor do raw materials manufacturers like Chevron Phillips and Phillips Sumika expect companies to inform them of how they intend to use the polypropylene resin they provide."
http://www.cpchem.com/msds/100000000792_SDS_EU_EN.PDF Marlex is Polyethylene FYI and this is the MSDS...
MEDICAL APPLICATION CAUTION: Do not use this material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues fluids or tissues. Do not use this material in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from Chevron Phillips Chemical Company LP or its legal affiliates under an agreement which expressly acknowledges the contemplated use. Chevron Phillips Chemical Company LP and its legal affiliates makes no representation, promise, express warranty or implied warranty concerning the suitability of this material for use in implantation in the human body or in contact with internal body fluids or tissues.
BIOLOGICAL RESPONSES TO MATERIALS http://www.bioen.utah.edu/faculty/pat/Courses/Biomaterials/BiologicalResponse.pdf
IN A NUTSHELL; Companies like DuPont were selling these materials to medical device companies even though they KNEW it had not been studied or proven safe for medical device implantation. The biggest lawsuit they faced involved the TMJ Jaw Implant. http://1.usa.gov/1FzJKft “These implants, all of which are made of ProplastR (TeflonR -carbon or Teflon – aluminum oxide fiber composite), have been associated with implant perforation, fragmentation and/or a foreign body response.” Teflon; http://www.polymer-search.com/teflon.html Surprise Surprise! Another Polymer!!
DuPont started to withdraw this raw material or “plastic” from the market out of fear of litigation. Well, lobbyist used the argument that they needed these materials to manufacturer life saving devices such as heart valves and pacemakers. They won and the Biomedical Access Assurance Act was passed in 1998.
Here’s the kicker… Over 20 years later, and these materials were sold to medical device companies for use in devices such as pelvic mesh and Essure… NOT life saving devices!! There are still NO studies to prove the safety of these plastics, and we all have the same symptoms as the patients harmed by this material before the Biomaterials Access Assurance Act was passed… autoimmune, foreign body reactions! Add the possibility of perforations, allergic reactions, toxicity with the metal coils in Essure, and much much more.. These devices were destined to fail and they have been implanted in hundreds of thousands of men and women (some very very young) to wear for the rest of their lives. Again…ZERO testing!!!
Thank you for taking the time to read this. I feel this is incredibly important for people to realize because everyone is telling us the fibers are Ok and safe, and that they have a long history and have been proven in heart stents. No, the fibers have NOT been proven! They have been lobbied and bought!! Repeal the Biomaterials Access Assurance Act of 98!!!
~Written by Amanda Dykeman (Essure Injured Patient)