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07/08/2008 06:41 PM

Chronology of Implant Disaster. Why is FDA's diff

Ruthie
RuthiePosts: 73
Member

What do you all think?

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.srt-psc.com/7case00.html

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.

http://www.fda.gov/downloads/MedicalDevices/Safety/ AlertsandNotices/PatientAlerts/ucm070146.pdf

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 use in the TMJ joint!!!????? REALLY

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/onn62s1.pdf

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"Wink

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"Wink

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 Sad

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

Post edited by: Ruthie, at: 03/10/2010 06:33 PM

Reply

07/10/2008 04:43 PM
Ruthie
RuthiePosts: 73
Member

It seems the FDA is sill having labeling and PMA problems 26 years after the 1992 Congressional Hearings. How can this stil be going on? I just don't get it. Someone should be held accountable. And to think our tax dollars are paying their pay-checks and great medical and pension benefits.

07/16/2008 09:49 AM
Ruthie
RuthiePosts: 73
Member

Just found this today http://www.devicelink.com/grabber.php3?URL=http:// www.devicelink.com/mddi/archive/08/07/009.html

Post edited by: Ruthie, at: 03/10/2010 06:37 PM


09/14/2008 10:46 AM
Ruthie
RuthiePosts: 73
Member

Please help Bhopal victims ss they are still fighting Dow Corning/Chemical/Union Carbide http://www.studentsforbhopal.org/

Because this is only one of a series of events that shows a course of action on Dow Corning/Chemical to delay litigation and be held accountable and compensate victims for their negligence.


12/11/2008 11:36 AM
fluffyluggage
fluffyluggage  
Posts: 4722
VIP Member
I'm an Advocate

Hey Ruthie,

Can you give me an update on how things are going and where the progress is now? I see that you last post was almost 3 months ago, and I'd love to know what's going on now! I'm trying to really get the TMJ forum a lot more active, and I see that you were really active before, so I'd love to have you come back over...

Pop back in and update us when you get the chance! Also, let me know how things are going for you, wouldja?

*hugs* Be well, and pain-free!

Jen Smile


11/08/2009 06:37 PM
Synergy463
 
Posts: 223
Member

Bump

12/07/2009 06:58 PM
uwhusky
Posts: 2
New Member

This is in response to Ruthie's comments about Silastic and Proplast-coated TMJ implants, the failure of the FDA to protect the public vis a vis artificial devices manufactured for use in the human boday, and her bad feelings about her surgeon, Dr. Clyde H. Wilkes, of Minnesota (now retired).

1) Silastic and Proplast were both known to fragment under excessive functional loading in the TMJ by the mid-1980s. Scientific information was published and is well-summarized by articles which appeared in "Oral and Maxillofacial Surgery Clinics of North American," Vol. 1, December, 1989. This publication is available via Medline or the medical library of your local hospital. I would suggest you review it.

2) When Silastic or Proplast fragment under functional loading within the TMJ, in many, but not all, patients there is an intense giant cell inflammatory response provoked which usually leads to resorption of bone (mandibular condyle and glenoid fossa) within the TMJ, causing pain, foreshortening of the condyle, altered occlusion and difficulty with chewing solid or semi-solid food.

3) Surgeons who had placed Silastic or Proplast implants began to remove them by the mid- to late 1980's as evidence of the TMJ damage began to be well-known amongst oral & maxillofacial surgeons, even before the FDA finally ruled that these products be taken off the market for permanent joint implantation. It was subsequently determined that a TMJ that had had its disc (meniscus) removed, and then its implant (Silastic or Proplast) removed might function better if there were some type of interpositional tissue or material between the glenoid fossa and the mandibular condyle to prevent bone-on-bone contact. Such contact in a functionally-loaded joint, inevitably leads to arthritic deterioration. So some surgeons came up with the idea of a temporary silastic interpostional implant, after removal of a failed implant. The implant was placed and allowed to stay in situ for 2-6 months, during which time a fibrous connective tissue capsule formed around the silastic. After the temporary silastic was removed, this pseudomeniscus (capsule) functioned somewhat like a meniscus, protecting the bony surfaces from direct contact with each other. This is why Dr. Wilkes placed a temporary silastic implant into your diseased TMJ. At that time, it was one of the best options for you, having experienced failure of your previous "permanent" implant. Telling Dr. Wilkes nothing about your further difficulties until 25 years later, was not helpful, when earlier intervention might have helped you.

4) Not all alloplastic TMJ implants failed. The critical factor in failure seemed to be that functional overloading of the TMJ with various parafunctional activities (tooth grinding, jaw muscle clenching, abnormal jaw posturing, etc.) caused fragmentation of the implants with the resulting giant cell inflammatory response. In those patients in which parafunctional jaw activities could be controlled, the implants did not fail (I am a surgeon and have operated over 1,000 TMJ's, both primarily and secondarily for failures (e.g. removal of implants, etc.), so this is my personal experience.

5) Control of parafunctional jaw activities was always required of my patients, preoperatively. If the patient failed to cooperate, the operation was not done, because it would be doomed to failure. This information has been gathered over 35 years of practice and was not known or understood at the time your implants were placed.

5) What kind of patient were you? Fully compliant and cooperative with Dr. Wilkes' treatment plan, both before and after surgery? Expecting that an operation would "solve all my problems" and I don't have to do a thing myself? or Not following the surgeon's plan of supportive care and doing "my own thing" without his knowledge or consent? Your failure to notify or complain to Dr. Wilkes until 25 years later tells me something, unfortunately, about your compliance as his patient. The patient's full cooperation and compliance is always a critical factor in the success of any operation, and TMJ surgery, especially, is no exception.

6) At the time that Dr. Wilkes did your surgery, I am certain that your best interests were his primary concern and that he did what, based on his many years of experience in treatment of TMJ disorders, he felt was the preferred treatment for your particular condition. Just because things did not work out the best for you is NOT a reason to question Dr. Wilkes' motives or integrity, and seems blatantly unfair, especially in view of the fact that you did not inform him of further difficulty until 25 years after the fact.

7) As physicians, we have learned that the FDA has and will probably continue to fail us, and in turn our patients, in the timely and accurate evaluation, reporting and control of the materials, as well as drugs, that come under their perview. As a governmental agency, it is subject to intense political pressures, as well as lobbying by all the private businesses which produce products that fall under its so-called "control." You should be actively informing your U.S. Congressman and U.S. Senator about your concerns. His or her failure to respond should be made known to all constituents in your state and congressional district. The history of the FDA in regard to Silastic and Proplast is, indeed, shameful.

8) Since you currently reside in the Pacific Northwest (Sequim, WA), I would respectfully suggest that you contact the Department of Oral & Maxillofacial Surgery at either the University of Washington, Seattle, or at the Oregon Health & Sciences University, Portland to assist you in finding the proper specialist(s) to treat your current, on-going TMJ-related problems. You may need more than one physician (e.g. TMJ specialist, rheumatologist, Physical Med & Rehab, Neurologist, Surgeon, etc.). There may be a multi-specialty TMJ clinic at one or both of these two university medical centers. I do not know since I leave on the East Coast. Best wishes that you find the treatment that you need. God bless !!


12/08/2009 10:51 PM
Ruthie
RuthiePosts: 73
Member

This is in response to Ruthie's comments about Silastic and Proplast-coated TMJ implants, the failure of the FDA to protect the public vis a vis artificial devices manufactured for use in the human boday, and her bad feelings about her surgeon, Dr. Clyde H. Wilkes, of Minnesota (now retired).

1) Silastic and Proplast were both known to fragment under excessive functional loading in the TMJ by the mid-1980s. Scientific information was published and is well-summarized by articles which appeared in "Oral and Maxillofacial Surgery Clinics of North American," Vol. 1, December, 1989. This publication is available via Medline or the medical library of your local hospital. I would suggest you review it.

I have done a great deal of review regarding the breakdown and fragmenting of my silicone implant and could in all likelihood direct you to information that you may want to review. My point was missed apparently. The procedure was never explained or offered regarding its experimental status. Reviewing articles after the fact seems a bit late, and although education relating to the process is beneficial to some degree, it doesn't change the facts.

2) When Silastic or Proplast fragment under functional loading within the TMJ, in many, but not all, patients there is an intense giant cell inflammatory response provoked which usually leads to resorption of bone (mandibular condyle and glenoid fossa) within the TMJ, causing pain, foreshortening of the condyle, altered occlusion and difficulty with chewing solid or semi-solid food.

Are you serious? Do you think this has gone unnoticed, that I'm not living with these consequences of an unnecessary procedure every day of my life? You may think you're educating me on the properties and expected conditions of a failed implant, but I would hazard a guess that you have very little or no first hand experience in this matter.

3) Surgeons who had placed Silastic or Proplast implants began to remove them by the mid- to late 1980's as evidence of the TMJ damage began to be well-known amongst oral & maxillofacial surgeons, even before the FDA finally ruled that these products be taken off the market for permanent joint implantation. It was subsequently determined that a TMJ that had had its disc (meniscus) removed, and then its implant (Silastic or Proplast) removed might function better if there were some type of interpositional tissue or material between the glenoid fossa and the mandibular condyle to prevent bone-on-bone contact. Such contact in a functionally-loaded joint, inevitably leads to arthritic deterioration. So some surgeons came up with the idea of a temporary silastic interpostional implant, after removal of a failed implant. The implant was placed and allowed to stay in situ for 2-6 months, during which time a fibrous connective tissue capsule formed around the silastic. After the temporary silastic was removed, this pseudomeniscus (capsule) functioned somewhat like a meniscus, protecting the bony surfaces from direct contact with each other. This is why Dr. Wilkes placed a temporary silastic implant into your diseased TMJ. At that time, it was one of the best options for you, having experienced failure of your previous "permanent" implant. Telling Dr. Wilkes nothing about your further difficulties until 25 years later, was not helpful, when earlier intervention might have helped you.

It was not until 1978 when Wilkes used arthography to describe the anatomy,form and function of the TMJ, that disc repositioning became an accepted surgical technique. Wilkes theorized that there was a "very high probability that the signs and symptoms of the Temporomandibular joint-dysfunction syndrome are direct manifestation of internal derangement of the joint (articular disc displacement). "Before that time , routine recommended treatment for TMJ internal derangement was either to do nothing or remove the disc (diskectomy). "I would have been better off if Wilkes had just removed my disc." Wilkes in 1982 proposed the use of temporary silicone replacement to help avoid post-operative adhesions and its subsequent removal in 2-4 months. This was recommended to circumvent some of the longer complications of the wearing and thinning of the silicone with eventual fractures. "Why then did Wilkes place my one and only implant in for 5 months when he classsified me intermediate late stage? Why did he not use me in his studies after my failure? I did go back to him in pain and headaches only to be sent on my merry way given some pills which I took to know avail and had also conceived my first child which I did not know at the time. I saw a doctor in 1988 for my pain after the birth of my second child and the death of my father. This doctor was no help. I contacted Wilkes in the 90's to get my medical records which he said he did not have anymore, told me to contact the hospital and told me he was sorry I was in pain, with no mention of my implant problems. I contacted him again in 2002 after I was overdosed and lost a month of my life. This doctor did not know what to do with me. I also tried an appliance which cost $5000 and changed my bite. I was told by one of the girls that worked on me for over a year that they had meetings on me. I was also on liquid methadone and valium during this time."

4) Not all alloplastic TMJ implants failed. The critical factor in failure seemed to be that functional overloading of the TMJ with various parafunctional activities (tooth grinding, jaw muscle clenching, abnormal jaw posturing, etc.) caused fragmentation of the implants with the resulting giant cell inflammatory response. In those patients in which parafunctional jaw activities could be controlled, the implants did not fail (I am a surgeon and have operated over 1,000 TMJ's, both primarily and secondarily for failures (e.g. removal of implants, etc.), so this is my personal experience.

"I do not grind my teeth and my bite has been off since my surgery. I never snored until after my surgery either. It is getting more and more difficult to swallow." My MRI is ugly and I have chronic inflammation which shows on my face often."

5) Control of parafunctional jaw activities was always required of my patients, preoperatively. If the patient failed to cooperate, the operation was not done, because it would be doomed to failure. This information has been gathered over 35 years of practice and was not known or understood at the time your implants were placed.

"Then I guess I was truly used for experimental surgery without my knowledge or consent as they were being removed when he implanted me. He implanted me with silastic NRV-HP which failed in the hand and was of PDMS (silicone) and silica which was like sand on pearl."

5) What kind of patient were you? Fully compliant and cooperative with Dr. Wilkes' treatment plan, both before and after surgery? Expecting that an operation would "solve all my problems" and I don't have to do a thing myself? or Not following the surgeon's plan of supportive care and doing "my own thing" without his knowledge or consent? Your failure to notify or complain to Dr. Wilkes until 25 years later tells me something, unfortunately, about your compliance as his patient. The patient's full cooperation and compliance is always a critical factor in the success of any operation, and TMJ surgery, especially, is no exception.

"I was an exceptional patient. I ate baby food after my surgery and even tried spaghetti in a blender, which was awful. I am 5'4 3/4 and dropped down to 102 pounds." I continue to baby my jaw 25 years later."

6) At the time that Dr. Wilkes did your surgery, I am certain that your best interests were his primary concern and that he did what, based on his many years of experience in treatment of TMJ disorders, he felt was the preferred treatment for your particular condition. Just because things did not work out the best for you is NOT a reason to question Dr. Wilkes' motives or integrity, and seems blatantly unfair, especially in view of the fact that you did not inform him of further difficulty until 25 years after the fact.

"If Wilkes did have my best interest at heart he would have helped me. I do question Wilkes integrity as when I called him with my first MRI results he told me that I better get help. He denied my implant was in for 5 months. We got into a heated arguement and we both thought we hung up on each other. He called early the next morning and was then worried about me defaming his character? Why would he say such a thing if he did nothing wrong?" Why with what he knew with the failure of his design in me go on with the (Wilkes Design) and injure many more? Why were there labeling problems in the 1992 Congressional Hearings and look at the time frame they suggest implanting for, not to mention that they were known to be toxic!" I had silastic (R) placed in my finger in 1981 and had a reaction. Why was a warning letter sent to Dow Corning concerning the (Wilkes Design)?"

7) As physicians, we have learned that the FDA has and will probably continue to fail us, and in turn our patients, in the timely and accurate evaluation, reporting and control of the materials, as well as drugs, that come under their perview. As a governmental agency, it is subject to intense political pressures, as well as lobbying by all the private businesses which produce products that fall under its so-called "control." You should be actively informing your U.S. Congressman and U.S. Senator about your concerns. His or her failure to respond should be made known to all constituents in your state and congressional district. The history of the FDA in regard to Silastic and Proplast is, indeed, shameful.

"I have been written many U.S Congressman and all the Senators since 2002. Many have called and responded and some have been very helpful in sending me information. The Implant Disaster continues to this day, just look at the GAO reports. The FDA just won against the Christensen implant. I have an allergic reaction to metals and cannot even wear hypo-allergenic jewelery."

8) Since you currently reside in the Pacific Northwest (Sequim, WA), I would respectfully suggest that you contact the Department of Oral & Maxillofacial Surgery at either the University of Washington, Seattle, or at the Oregon Health & Sciences University, Portland to assist you in finding the proper specialist(s) to treat your current, on-going TMJ-related problems. You may need more than one physician (e.g. TMJ specialist, rheumatologist, Physical Med & Rehab, Neurologist, Surgeon, etc.). There may be a multi-specialty TMJ clinic at one or both of these two university medical centers. I do not know since I leave on the East Coast. Best wishes that you find the treatment that you need. God bless !!

"I have written and been ignored by the University of Washington. I was also ignored by a doctor that Wilkes trained. I have been offered a total joint replacement by e-mail with little information given. I have written to so many through the years. I have been disabled since 2002. My health continues to fail and still little is known. I am my best TMJ Specialist as I am living with it."

"I hope that I have answered your questions and that you see the corrections to your miss-diagnoisis of my medical history. I am not a doctor basher and have had many great doctors that I love, admire, and respect. The doctor that saved my fingers after 2 doctors wanted to cut them off is in my heart and prayers forever."

May God bless you and yours. Love, Ruthie Smile


12/09/2009 06:33 AM
Ruthie
RuthiePosts: 73
Member

3) Surgeons who had placed Silastic or Proplast implants began to remove them by the mid- to late 1980's as evidence of the TMJ damage began to be well-known amongst oral & maxillofacial surgeons, even before the FDA finally ruled that these products be taken off the market for permanent joint implantation.

"We know that Wilkes knew of there failure back in 1982."

It was subsequently determined that a TMJ that had had its disc (meniscus) removed, and then its implant (Silastic or Proplast) removed might function better if there were some type of interpositional tissue or material between the glenoid fossa and the mandibular condyle to prevent bone-on-bone contact. Such contact in a functionally-loaded joint, inevitably leads to arthritic deterioration.

"I now have bone-on-bone contact and arthritic deterioration, I have no discs on either side."

So some surgeons came up with the idea of a temporary silastic interpostional implant, after removal of a failed implant.

"Wow, and I never had the firstfailed implant...Where did Wilkes get the idea to put my implant in?"

The implant was placed and allowed to stay in situ for 2-6 months, during which time a fibrous connective tissue capsule formed around the silastic.

"Wilkes proposed in 1982 2-4 months yet placed mine in for 5."

After the temporary silastic was removed, this pseudomeniscus (capsule) functioned somewhat like a meniscus, protecting the bony surfaces from direct contact with each other.

" I guess this did not work as well."

This is why Dr. Wilkes placed a temporary silastic implant into your diseased TMJ. At that time, it was one of the best options for you, having experienced failure of your previous "permanent" implant.

"This was not the best option for me. I went in with bad headaches and popping of the jaw, he lead me to believe that this surgery would eliminate my problems."

Telling Dr. Wilkes nothing about your further difficulties until 25 years later, was not helpful, when earlier intervention might have helped you.

"As you can see in my previous response to this...I did contact him. What are his responsibilities? Do no harm? After the knowledge of my failure I would think he would want to take new xrays to see if there were new problems as a result of the failure?" Why in my many contacts did he never tell me of the Implant Disaster nor ever even notify me?"

4) Not all alloplastic TMJ implants failed. The critical factor in failure seemed to be that functional overloading of the TMJ with various parafunctional activities (tooth grinding, jaw muscle clenching, abnormal jaw posturing, etc.) caused fragmentation of the implants with the resulting giant cell inflammatory response.

"Since surgery I have a clenching problem. If I relax my jaw I have tremors and my jaw shakes uncontrollably. I am in a constant battle with my mouth."

5) Control of parafunctional jaw activities was always required of my patients, preoperatively. If the patient failed to cooperate, the operation was not done, because it would be doomed to failure.

"You truly must have been ahead of Wilkes and others. Where you removing implants in the 1980's? How long have you practiced having removed considering this statement?"

(I am a surgeon and have operated over 1,000 TMJ's, both primarily and secondarily for failures (e.g. removal of implants, etc.), so this is my personal experience.

This information has been gathered over 35 years of practice and was not known or understood at the time your implants were placed.

"Are you saying that you have gathered and practiced since 1984 or that others gathered this information in 35 years?"

5) What kind of patient were you? Fully compliant and cooperative with Dr. Wilkes' treatment plan, both before and after surgery? Yes I followed the diet sheet that was given in the hospital and to this day do the exercises he suggested to keep my range of motion, which is disappearing.

" Expecting that an operation would "solve all my problems" and I don't have to do a thing myself?

"Wilkes told me he could fix my problem before I had surgery."

or Not following the surgeon's plan of supportive care and doing "my own thing" without his knowledge or consent?

"With how he treated me...I guess he had no plan after failure and had no plan for supportive care...I went on trying to live my life with his complete knowledge and I feel his appreciated consent." I guess we both walked away from this experience with our own knowledge and never would I have given my consent to have silicone placed in my head. I used that that stuff on my chugga boots in Minnesota and saw what it did to the leather."

6) At the time that Dr. Wilkes did your surgery, I am certain that your best interests were his primary concern and that he did what, based on his many years of experience in treatment of TMJ disorders, he felt was the preferred treatment for your particular condition.

"Did he really? I highly doubt this because of the treatment I received after surgery as well as my contact with him through the years."

Just because things did not work out the best for you is NOT a reason to question Dr. Wilkes' motives or integrity, and seems blatantly unfair, especially in view of the fact that you did not inform him of further difficulty until 25 years after the fact.

"Why didn't he keep my medical records or tell me in a phone conversation in the 90's of the problems that had been found out? I went to another doctor in 1998 which I forgot to mention. He informed me that patients that had under gone surgeries had to have another about every 5 years. I did not know that I had a silicone implant yet. He took molds of my bite and wanted to put splints in me. He saw the problems with my balance and pointed out to my husband that I sat with my tilted forward to let my jaw hang. My hubby worked for the state and we had great medical insurance yet TMJ coverage still cost a fortune even back then. My daughter was also diagnosed with TMJ at this time.

Your failure to notify or complain to Dr. Wilkes until 25 years later tells me something, unfortunately, about your compliance as his patient. The patient's full cooperation and compliance is always a critical factor in the success of any operation, and TMJ surgery, especially, is no exception.

"I tried to comply with Dr. Wilkes...I went to him...he never came to me! A pathologist informed me that I would not be in so much pain had I not had my silicone implant."

"My first response I had written to you was lost some how and in my second I left out some answers to your questions and needed to add some questions of my own. Sad that there are so many unanswered questions all around. The truth,,is the truth, is the truth and this never changes and in this I have peace in my heart. Praise God glory on high!"

God love you, Ruthie


12/09/2009 08:15 AM
uwhusky
Posts: 2
New Member

Thank you for your detailed response, Ruthie. May you go in peace. God bless !!
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