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It seems the FDA is still having problems with labeling and PMA's, how can this still be happening today? WHY DOES THE FDA CONTINUE TO FAIL?Sent: Monday, October 25, 2004 2:59 AM To: DSMICA@cdrh.fda.gov Subject: tmj implants/silastic HP I was questioning why silastic hp was still being used and placed in 9 year olds jaw in 2000 and have seen silicon placed in a jaw in 2002 http://www.healthboards.com/ubb/Archives/Archive-000004/
HTML/20030413-119 This is in response to your email below to the Food and Drug Administration (FDA) requesting information on silastic sheeting used in jaw implants. The silastic sheeting was involved in the TMJ problems of the late 80's and 90's and were taken off the market. However, silastic sheeting is used for other purposes in plastic surgery and is generally available to surgeons. Therefore, a surgeon could use silastic sheeting that is labeled for some other use in the TMJ under the general practice of medicine, e.g., a doctor may use any product off label if they wish to. So are you saying that the doctors can do what ever they want...and the FDA is still not protecting TMJ patients? I don't understand..Doesn't this leave you and doctors open for lawsuits?FDA does not have any jurisdiction over physicians, they fall under the purview of each individual state licensing board. However, if a physician is using an unapproved medical device, he/she must comply with FDA's Investigation Device Exemption (IDE) regulations. Hope this helps.This taken off your page http://www.fda.gov/cdrh/consumer/tmjupdate.html.On June 15, 1993 Dow Corning discontinued the marketing of H.P. sheeting, Silastic TMJ implants, and medical grade sheeting and block material. Other manufacturers are marketing silicone sheeting that is indicated for a variety of uses. FDA is presently working with manufacturers to appropriately label silicone sheeting with warnings against its use in theTMJ implant. I would have hoped by this statement that the response above would have been...Thank you for bringing this to our attention. We will contact this doctor and find out what company he purchased his product from and get in contact with this company and also send out a warning to all doctors. Seems simple....Isn't this what you promise to do? Why such Gaps in your page, and not updated with important information to patients? By Dow Corning and others being able to bow out is like me taking a bomb to Dow Corning, bow out and walk away. The bomb goes off and I am not liable? Because I bowed out. Makes no sense to me. Why are there still all the same problems going on today? Who isn't doing their job or jobs. Who has more rights the companies, doctors, FDA or the patients? What good does it do to report medical problems if nothing is done about it? Who does the FDA really work for? America is not a country anymore, it is a business and a business with the ethics, character and morals of Dow Corning I quess! My list below is far from done but will send it off to many and see what kind of imput I get from them. I will pray for those who are still having silastic/silicon placed in their jaw joints for a different outcome then mine. Sincerely, Ruthie Ruth A. Peterson 371 ElCamino Dr. Sequim, WA 98382 I will continue to pray for my peace of mind of what my silicon/silicone fragments are doing and the truth. I question how the FDA, Corporations and doctors can have any peace of mind at all. I put this together using the information from www.orthopedicnetworknews.com and the 1999 Consumer Information Update! And My OWN input. WHY ISN'T THE FDA GIVING ALL THIS INFORMATION? WHY SUCH GAPS. CHRONOLOGY OF AN IMPLANT DISASTER The following are some of the relevant publications, filings, and correspondences in this episode. Date(s) Source Event THE BACKGROUND RESEARCH April 6, 1938 – Teflon is Discovered 1963 12/28Lancet CHARNLEY WARNS against the use of TEFLON in JOINTS because of INTENSE FOREIGN-BODY REACTIONS. Describes UNFAVORABLE RESULTS of INJECTING TEFLON into HIS OWN THIGH. 1967 WSJ DUPONT sends HOMSY WARNING about COMPLICATIONS caused by IMPLANTED TEFLON. 1968 WSJ PROPLAST developed by HOMSY at DUPONT. 1969 .First report 1969 silastic used in TMJ joint (popular in ther 1970"s) DOW CORNING HAD CONCERNS OF IMPLANTATION IN LOADED JOINTS. 1970 Christensen and Morgan Implants 1970"s ONN HOMSY starts VITEK. 1974 WSJ KENT started collaboration with HOMSY. 1976 Silastic Sheeting (Dow Corning, Midland, MI) 1976 5/28 FDA MEDICAL DEVICE AMENDMENTS: PREMARKET NOTIFICATION is NOT Required for devices developed prior 5/28/76. May 28, 1976 -The Medical Device Amendments were enacted giving FDA authority to REGULATE medical devices, such as TMJ implants, which were already on the market. 1976-1983 Medical Device Amendment 1978 3/1/TMJ EARLIEST KNOWN RECIPIENT of VITEK PROPLAST/TEFLON IMPLANT. 1822 3/30 FOI KENT writes HOMSY that procedures TO RISE to 10,000 PER YEAR for TMJ IMPLANTS. 1982, OCT JOMS WOLFORD compares SILASTIC to PROPLAST in 12 patients. Follow-up ranged from one to four years. No differences in comfort, mobility. PROPLAST HAD BETTER LONG-TERM STABILITY THAN SILASTIC. *****SILASTIC WAS FAILING**** 1982, 11/23 FOI VITEK files intent to market INTERPOSITIONAL IMPLANT (IPI) with FDA. 1982 Dr. Clyde H. WilkesProposed the use of temporary silicone replacement to help avoid post-operative adhesions and its subsequent removal in 2-4 months {40} . This was recommended to circumvent some of the longer complications of the wearing and thinning of the silicone with eventural fractrues {40,44} {40}Ryan D. Alloplastic disc replacement. Oral Maxillofac Surg. Clins N AM 1994;6:30721 {44}Tucker MR, Burkes Jr EJ. Temporary silastic implantation following discectomy in the primate temporomandibular joint J Oral Maxillofac Surg 1989; 47: 129-5 Why did Dr. Clyde H. Wilkes leave my implant in for 5 months in Oct 1984?? $$$$$$$$$$$ DISTRIBUTION BEGINS 1983 Proplast I (Vitek, Houston, TX) 1983, 3/23 FOI FDA notifies HOMSY that IPI is equivalent to device marketed prior to May 28, 1976. March 1983 - Vitek, Inc. notified FDA that it was planning to market the Interpositional Implant (IPI) to treat TMJ problems. The firm claimed that it was SUBSTANTIALY equivalent to anEXISTING product, SILICONE SHEETING which was ALSO USED as a TMJ implant. FDA agreed with the manufacturer's claim of EQUIVALENCE and the IPI device was allowed to be marketed.* 1983-1990 Proplast II (Polytetrafluoroethylene) pre-cut discs 1983 COMMERCIAL DISTRIBUTION of IPI IMPLANTS BEGINS! 1983, 12/9 FOI 510(K) approval for DOW CORNING SILASTIC TMJ IMPLANT H.P. based on SUBSTANTIAL EQUIVALENCE to SILASTIC SHEETING marketed prior toMay 26, 1976. 1984, 2/14 FOI KENT concerned about SAFETY of Vitek implants, WARNS HOMSY of "CALAMITY OF UNBELIEVABLE PROPORTIONS" 1984 WSJ FIRST ANIMAL dog studies, done on IPI. 1984, July JBJS TULLOS, et. Al. Report 36% of 47 hips coated with PROPLAST FAILED after an average of 37 months. CONCLUDED that coating had INSUFFICIENT STRENGTH to WITHSTAND NORMAL WEIGHT-BEARING LOADS. Dow Corning KNEW this back in the 1970's and EVEN BEFORE THIS !!!!!! 1984, October/16 Ruthie TMJ SURGERY on RUTHIE, by DR. CLYDE H. WILKES in Mpls, MN. SILASTIC NRV-HP Lot # MISSING???? How did my implant get from Dow Corning, to the hospital, to the operating room, into Dr. Wilkes hands and into my jaw joint????????? 1985, March/18 Ruthie RUTHIES SILASTIC IMPLANT removed 5 months, WORN ,GROUND THROUGH...FAILED! Implant also removed by DR. CLYDE H. WILKES (Wilkes Design with Dow Corning) Went back still complaining of headaches....gave me some pills...BYE BYE BYE...Never contacted me till I contacted him years later! COMING UP AHEAD....On market 1987-1993...Doctor and Implant also mentioned in 1992 Congressional Hearings...All this is IMPORTANT ! PEAK year for implants! $$$$$$$$$$$$$$$ 1985 Proplast IPI inserted in approximately 25,000 to 30,000 patients GROWING CONCERNS 1985, May TMJI FIRST PROBLEMS with PROPLAST reported by RYAN. ("DEGENERATION OF CONDYLES") 1986, Apr CONG FIRST Vitek Proplast Medical Device Report! EVER? 1986, Apr DCNA MORICONI et. al. "The TMJ IPI'S should be SINGLED OUT as having provided a NEW and MORE PREDICTABLE mode of TMJ RECONSTRUCTION." 1986, Jul JOMS TIMMIS et. al. REPORT GIANT CELL REACTIONS by rabbits Proplast/Teflon And SILACONE IMPLANTS. "Indicate a NEED FOR FUTHER EVALUATION of theseMATERIALS as DISC REPLACEMENTS IN HUMANS!" 1986 Oct, AAOMSm El DEEB reports 6 monkeys showed PROPLAST FRAGMENTATION with GIANT CELL REACTIONS AFTER 3-12 MONTHS! 1986, Oct, WSJ Vitek's survey of oral surgeons 91.5% of 5,070 satisfactory results. Vitek says pronosis for IPI"S success beyond 3 years UNKNOWN in package insert! 1987, 2/20 FOI U.S. Air Force REPORTS PROBLEMS with PROPLAST to VITEK, FDA ("SEVERE PAINFUL AND NONPAINFUL FOREIGN BODY REACTION WITH RESORPTION OF CONDYLE AND GLENOID FOSSA") 1987, Spring HC FIRST Lawsuit against VITEK! 1987 DC WILKES design TMJ IMPLANT marketed by DOW CORNING! REMEMBER Dr. Clyde H. Wilkes who Performed my surgery and KNEW my implant FAILED back in Mar. 18, 1985! SHUTDOWN-THE BUREAUCRACY SWINGS INTO ACTION 1988 When? FDA FDA became aware of COMPLAINTS about the IPI IMPLANTS and explants showing BONE RESORBTION, IMPLANT FRAGMENTATION, and DELAMINATION... 1988, June WSJ Distribution of IPI SUSPENDED by Vitek! 1988, July WSJ FDA conducts FIRST INSPECTION OF VITEK'S PLANT! 1989, Mar HC FDA cites Vitek for NOT REPORTING PATIENT COMPLAINTS through Medical Device Reports (MDRs) 1989, May JOMS El DEEB publishes 1986 FINDINGS ON MONKEYS. 1989, Jul, JOMS VALENTINE et. al. 9 PATIENTS (14 JOINTS) showed DETERIORATIONS, FORIEGN-BODY GIANT CELL REACTION IN ALL JOINTS! 1989, Oct, FDA FDA issued a letter to Vitek, Inc., a REGULATORY LETTER for Medical Device reporting (MDR) and Good Manufacturing Practices (GMP) VIOLATIONS! Dec 1989 OMSC Yih/Merrill report"both silicon rubber and Teflon-Proplast ar not biologically acceptable implant materialsIn the functional TMJ" 1990 Vitek issues safety and cessation of manufacturing January 26, 1990 - FDA issued a letter to Vitek, Inc. Advising them to WARN all oral surgeons of record against implanting further devices and MONITORING their PATIENTS until further clinical data was evaluated demonstrating long term safety and effectiveness. Mar 1990 Reports started to surface of problems with Proplast and Silicone 1990, 3/23 FOI Vitek issues letter advising Docs that IPIs could fragment. March 23, 1990 - Vitek, Inc., issued a "Dear Doctor" letter informing doctors of the hazards associated with the IPI product and advising them to closely monitor all patients by clinical and radiographic examination. FDA classified this action as a voluntary safety alert. 1990, June Oral Surgery Marketing, Inc (OSMI) takes over Vitek products June 1990 - Vitek, Inc., filed for bankruptcy. Oral Surgery Marketing, Inc. (OSMI) and Novamed, Inc., were created. July 27, 1990 - FDA issued Vitek, Inc., a letter informing it that its VOLUNTARY SAFETY ALERT WAS INEFFECTIVE. An audit check of the safety alert disclosed that some consignees were never notified. what about the patients)????????????????????? ________________________ *FDA was given the authority under the Federal Food, Drug and Cosmetic Act to regulate medical devices in 1976, including TMJ implants. Devices on the market before 1976 were "grandfathered"; that is, they were allowed to remain on the market. Under the law, manufacturers can inform FDA that a product they plan to market is substantially equivalent to a product that was on the market before 1976. FDA must then make the final decision about the equivalence. If FDA decides that the new device is equivalent, it can be marketed. 1990, 8/30 FDA FDA...RESCINDS 510(k) for Vitek's IPI IMPLANT! (SILASTIC STILL MOVING ON) Over 5 years since my implant FAILED......Whats going on with Dow and Wilkes?? He is known as the grandfather of TMJ by one he trained whom runs an institue and has ignored my e-mails??????? 1990, Sept OSOMOP Estabrooks reports 88.7% surgical success with Proplast/Teflon implants with average follow-up of 33 months. Only 10% removal. 1990 Oct Bankruptcy of Vitek secondary to Malpractice Claims 1990 Oct FDA (Center for Devices and Radiological Health) identification program to find all implant patients 1990, Oct HC FDA...SEIZED ALL IMPLANTS MANUFACTURED BY VITEK, NOVAMED, INC. And OSMI. (NovaMed, a sister company of Vitek, manufactured hip implants)!!!!!! 1990, 12/28 FDA FDA...SAFETY ALERT to oral and maxillofacial surgeons WARNING OF COMPLICATIONS associated with Proplast/Teflon..(Why didn't FDA warn back in January 26, 1990 when Vitek was told to do so)??????? Wilkes continues on injuring many!!!!!!! 1990, Dec 28 FDA FDA...RECLASSIFIED Viteks, Inc.'s voluntary safety alert to a Class 1 recall and issued a safety alet to all oral and maxillofacial surgeons WARNING of serious problems with proplast/coated TMJ implants manufactured by Vitek, Inc., and Oral Surgery Marketing, The FDA alert also advised surgeons to monitor all patients on a regular basis for possible loss of implant integrity and /or progressive bone degeneration... December 28, 1990 – FDA reclassified Vitek, Inc.'s voluntary safety alert to a Class I recall and issued a safety alert to all oral and maxillofacial surgeons warning of serious problems with proplast-coated TMJ implants manufactured by Vitek, Inc. and Oral Surgery Marketing, Inc. The FDA alert urged surgeons to refrain from using the device and to return all unused devices to the bankruptcy trustee for Vitek, Inc. The alert also advised surgeons to monitor all patients on a regular basis for possible loss of implant integrity and/or progressive bone degeneration. 1991, 1/7 FDA FDA recalls Vitek IPI (Class 1 Recall) January 7, 1991 - FDA issued a press release announcing a recall of Vitek Inc.'s jaw implants, describing the possible health hazard associated with the product. The release encouraged all people with implants to contact their implanting dentist and urged all dentists to reexamine their patients to see if the implants should be replaced. It also directed oral surgeons to return all unused implant to the bankruptcy trustee.1991, Mar? FDA FDA recieved a Public Citizen/Health Research Group PETITION REQUESTING that ALL PATIENTS with TMJ IMPLANTS be ALERTED of ASSOCIATED RISKS!!! 1991, Mar? FDA FDA conducted a MASS SEIZURE of ALL OSMI/MOVAMED ARTICLES AND DEVICESComposed of proplast. A Federal judge subsequently ruled in favor of FDA!!!!!!!! THE SEIZED ARTICLES WERE FORFEITED TO FDA! (This should have been done to Dow Corning) Remember back in 1982 Proplast had better long term stability than Silastic)! DR. CLYDE H. WILKES KNEW IT FAILED WITH ME BACK IN MARCH 1985 March 1991 – FDA received a Public Citizen/Health Research Group petition requesting that all patients with TMJ implants be alerted of associated risks. March 1991 – FDA conducted a mass seizure of all OSMI/Novamed articles and devices composed of proplast. A Federal judge subsequently ruled in favor of FDA. The seized articles were forfeited to FDA. October 1991 – FDA initiated the Patient Notification Program for Vitek's IPI implant. This involved a mass media campaign to publicize problems associated with proplast devices. This effort included press and video news releases, notification to professional and consumer journals and magazines, and letters to oral surgeons and related health care professionals. 1991, 10/2 FDA FDA issues medical alert to patients with Vitek implants! 1991, Fall ONN Bankruptcy court appoints JAMS to referee Vitek lawsuits... 1992, Feb JOMS FONENOT reports that laboratory test of IPI'S show that they have a SERVICE LIFE of about 3 years..Intermediate and long term survival of implant is UNCERTAIN! 1992, Mar HC HOMSY MOVES TO SWITZERLAND.................. 1992, Jun HC Implant inventory of NovaMed and OSMI....CRUSHED WITH A BULLDOZER, BURIED IN HOUSTON DUMP! June 1992 - FDA ordered Novamed, Inc., and Oral Surgery Marketing, Inc., (subsidiaries of Vitek then defunct) to immediately notify all customers to cease distribution and use of replacement devices for the TMJ joint, VK, VK-1, and VK-11, and blocks and sheets of proplast used in weight-bearing positions in the body. The firms were also ordered to contact all health professionals and device user facilities currently in possession of the devices and inform them of FDA's order concerning the devices and instruct them to cease use of these devices in the TMJ joint. FDA determined that the firms made an inadequate effort to comply with this order. THE AFTERMATH 1992, 6/4 CONG Congressional Hearings on TMJ implants.................................. June 29, 1992 - FDA/CDRH staff met with representatives of AAOMS to discuss patient abandonment, reimbursement issues, and recommendations for patient follow-up and future research efforts. AAOMS agreed to distribute a "TMJ Implant Advisory" to more than 6,000 AAOMS members and to publish the "Advisory" in their Journal. July 7, 1992 - FDA/CDRH staff met with representatives of the Health Insurance Association of America to discuss insurance coverage for TMJ-related disorders. September 1, 1992 - FDA published a proposed regulation classifying the IPI, condylar and fossa prostheses into Class III September 18, 1992 - FDA published a proposal in the Federal Register to reclassify TMJ Implants and components including interpositional use, from Class II to Class III devices. 1992, Oct OSOMOP SPAGNOLI/KENT report that of 465 patients with IPI, 86% of implants were still in placeafter an average of 32 months. 92.4% were asymptomatic, however 249 showed some degree of CONDYLE RESORPTION....PROJECT that 54% may fail. October 1992 - At FDA's request, the Medic Alert International Implant Registry established an 800 number for patients and physicians to request information about Vitek TMJ implants and to join a registry. October 30, 1992 - FDA participated in NIDR workshop to develop a surveillance instrument for assessing the frequency, cost, and effects of TMJ surgery in the U.S. 1992, Nov AAOMS AAOMS workshop on TMJ implants. "Recommend removal of Teflon/Proplast implant and Affected soft tissues." November 28, 1992 - "FDA Needs Your Help" was exhibited at the Greater New York Dental Meeting. This exhibit alerted doctors to the need to notify patients with Vitek implants to call Medic Alert and enroll in the registry. December 2, 1992 - FDA notified Dr. Christensen that the Christensen Fossa and Condylar prostheses have pre-Amendment status. Based on what...LOOK WHAT HAPPENED WITH THIS IMPLANT December 7, 1992 - FDA Inspection of Dow was requested due to consumer reports of problems associated with the Wilkes design and Silastic sheeting (35 MDR/PRP reports). ALL RECORDS SHOULD HAVE BEEN SEIZED ACCORDINGTO RUTHIE! (INCLUDING DR. CLYDE H. WILKES) December 29, 1992 - FDA notified all six TMJ manufacturers that two TMJ devices are pre-Amendments devices, which allows the other four companies to market their devices through the premarket notification [510(k)] process instead of the more rigorous premarket approval (PMA) process. WHICH 2 DEVICES??? AND BASED ON WHAT...WHY 1993 FDA sends letters to Dow Corning, The Temporomandibular Research Foundation (Morgan), Osteomed Corporation, Techmedica Incorporated, TiMesh Incorporated, TMJ Implants Incorporated (Christensen) 1993, 1/26 ONN DOW CORNING EXITS THE TMJ BUSINESS........WHY?..Guilty..Afraid of getting caught!!! February 11, 1993 - The Dental Devices Panel met and reaffirmed FDA's position to reclassify TMJ implants as Class III devices. 1993, Apr JOMS WOLFORD reports revision surgery after Proplast/Teflon failure 88% of 163 joints showed Significant Osseous Changes after 2 to 126 months.... April 4, 1993 - FDA issued a warning letter to Dow citing the need for the submission of 510 (k)s for the Silastic HP sheeting, Medical Grade Sheeting and Wilkes design. Dow responds that, effective March 31, 1993, they discontinued marketing all implant-grade silicone. FAILING IN 1982...FAILED IN ME 1985  1993, Apr 4 FDA FDA issued a WARNING LETTER to DOW CORNING citing the need for submission of 510(K)s for the Silastic HP sheeting, Medical Grade Sheeting and Wilkes design. Dow Corning responds that, effective March 31, 1993, the DISCONTINUED MARKETING ALL IMPLANT-GRADE SILICONE.... ( Do you see a pattern here)???? .HOW DID DOW CORNING GET OFF SCOTT FREE?????????..... 1993, 4/26 ONN Class Action lawsuit filed AGAINST DOW CORNING AND DUPONT ON BEHALF OF BOTH VITEK AND DOW CORNING SILASTIC TMJ RECIPIENTS.........WOW.. June 9, 1993 - FDA notified Dr. Morgan that his TMJ implants have pre-Amendments status. On June 15, 1993 Dow Corning discontinued the marketing of H.P. sheeting, Silastic TMJ implants, and medical grade sheeting and block material. DO YOU SEE THE PATTERN HERE??? 1993, Jun 18 FDA A 510(K) for TMJ implant was received from Osteomed... June 18, 1993 - A 510(k) for a TMJ implant was received from Osteomed. Summer 1993 - FDA's Office of Compliance authorized "urgent use" of the Techmedica TMJ implant in 12 patients August 29, 1993 - Tracking requirements of the Safe Medical Devices Act became effective. Manufacturers of certain devices, including TMJ implants, must establish tracking systems, which will enable them to promptly locate devices in distribution. Newly marketed devices subject to tracking are also subject to postmarket surveillance studies. 1993, Aug 31 WSJ WSJ article about TMJ patients. 1993, Sept-Oct 20/20, American Journal, Current Affair segments aired on ABC TV.... 1993, Sept 10 FDA FDA learned that Dr. HOMSY was attempting to market Proplast TMJ products in Europe and FDA wrote a letter to WHO citing AGENCY CONCERNS.. WHAT ABOUT DOW CORNING CONCERNS????????????????????????????????????? September 10, 1993 - FDA learned that Dr. Homsey was attempting to market Proplast TMJ products in Europe and FDA wrote a letter to WHO citing Agency concerns. October 12, 1993 - FDA staff met with representatives of Dow to discuss an increase in the number of problem reports associated with the Wilkes IPI and Silastic sheeting used in TMJ. Dow agreed to send an advisory to its consignees. ...(.WHAT ABOUT RUTHIE) October 29, 1993 - FDA developed a 510(k) guidance document for manufacturers of TMJ implants advising them how to set up protocols for evaluations of their products. The guidance addressed the length of time required to conduct studies and follow-up of their products. WHAT WAS FOUND OUT) Still problems with this****GAO Reports October 29, 1993 - FDA sent letters to Techmedica and Osteomed requesting additional information on their TMJ implants. This resulted in withdrawal of both 510(k)s. FDA would expedite the processing of new applications received. .How did DOW get away with so much......No reports...letters...ACCONTABILITY!!!! December 8, 1993 - Dow issues letter to consignees regarding Silastic sheeting and the Wilkes IPI ( 1 YEAR AFTER FDA INSPECTION DONE DEC. 7, 1992)??????????????? February 14, 1994 - A draft classification regulation to re-propose the fossa and condylar prostheses into Class III was published. April 17 - 20, 1994 - FDA co-sponsored a conference with National Institute of Dental Research entitled, "Management Requirements for a National Implant Data System." The planning conference served to accelerate the process of producing a unified approach to the study of biological host and implant response performances of various biomaterials and devices in HUMAN CLINICAL USE. 1994, Jul 15 FDA FDA sent a "Dear Doctor" letter to all U.S. plastic and reconstructive surgeons, orthopedic Surgeons, and otolaryngologists concerning problems with Proplast TMJ Implants.... WHAT ABOUT SILASTIC SHEETING AND WILKES DESIGN??????? July 15, 1994 - FDA sent a "Dear Doctor" letter to all U.S. plastic and reconstructive surgeons, orthopedic surgeons and otolaryngologists 1994 Sept Remainder of products removed from the market except the grand fathered Christensen and Morgan 1994, Sept ? FDA FDA revised its "TMJ Implants: A Consumer Information Update." September 12-13, 1994 - FDA sponsored an "International Satellite Workshop on the TMJ and Related Pain Conditions." September 14, 1994 - FDA sent a letter to Japan, Italy, Switzerland, Canada, Mexico, Australia, New Zealand and the Director General of EC in Belgium to inform regulatory bodies about the Proplast TMJ experience in the U.S September 1994 - FDA revised its "TMJ Implconcerning problems with Proplast TMJ implants.ants: A Consumer Information Update." 1994, Nov 17 FDA FDA sent a letter to all TMJ implant patients in the Medic Alert International Implant Registry(IIR) informing them that the IIR will NO LONGER INFORM THE MEDICAL DENTAL COMMUNITY and TMJ resource organizations of any problems related to Vitek TMJ Implants!!!!!!!!!!!!!!!! November 17, 1994 - FDA sent a letter to all TMJ implant patients in the Medic Alert International Implant Registry (IIR) informing them that the IIR will no longer continue its operation. FDA will continue to inform the medical and dental community and TMJ resource organizations of any problems related to Vitek TMJ implants. 1994, 12/20 ONN FDA reclassifies TMJ implants as Class III..... December 20, 1994 - A final rule to classify the IPI, total joint, fossa, and condylar prostheses into Class III devices was published in the Federal Register... 1995, Oct 16-17 FDA FDA participated in the NIH Workshop "Biomaterials and Medical Implant Science: Present and Future Perspectives." October 16-17, 1995 - FDA participated in the NIH Workshop "Biomaterials and Medical Implant Science: Present and Future Perspectives." 1995, 4/1 ONN Claims against Vitek EXCEED 2,200, EXCLUDING ABOUT 500 PATIENTS WHO RECEIVED ...$1,000...TOTAL REIMBURSEMENT...........WOW......... April 29-May 1, 1996 - NIH convened the Technology Assessment Conference: "Management of Temporomandibular Disorders." July 17, 1996 - The Anspach Total Temporomandibular Implant (formerly known as the Techmedica Implant, and now distributed through TMJ Concepts) received premarket notification 510(k) clearance which will require device tracking and postmarket surveillance. August 2, 1996 - FDA issued letters stating the agency's intention to rescind the determinations of substantial equivalence (SE) for nine 510(k)s Proplast devices which are used in loaded situations, (for example in joints July 1997 Bankruptcy Court awards to over 2500 litigants based on point system: all awards less than $$10,000 Dental Research of National Institutes of Health (NIH) Meeting with funding for research into chronic problems of Alloplastic Disc replacement July 1997 FDA approves the marketing of Techmedica Total Joint Prostheses again; the first models to be ready in 1997 (new name is TMJ Concepts) June 19, 1998 - FDA rescinded the determinations of SE for four of the nine 510(k)s and the remaining five are being reviewed. December 30, 1998 - FDA published a final 515(b) regulation in the Federal Register that requires manufacturers of TMJ implants to submit PMAs with data showing the safety and effectiveness of the implants. This should have been figured out back in 1976) NOT 22 YEARS LATER!!!!!!! I not only hope this passes, but also it is taken serious and REALLY PROTECTS the PATIENTS ! HEALTH LEADERS IN CONGRESS INTRODUCE LEGISLATION REVERSING SUPREME COURT'S MEDICAL DEVICE DECISION Legislation will Protect Patients from Dangerous & Defective Devices http://kennedy. senate.gov/ newsroom/ press_release. cfm?id=86739FE7- B6C1-4C2F- 9BF3-409D6348BED 0 Praise God for this! Love, Ruthie
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"Hello...my name is crystal, my father recently passed away from with pancreatic ..." (xcrystalx216)