_^^ _““_ __^”x”““,““__ “_“.”
xI”,_I”^___
J Oral Maxlllofac 49:1361-1362.
“__
_^~~^^“““_“__
Surg
1991
throughout the immune system.” Dr Homsy’s letter references “foreign-body reaction” as being “a biological response directly analogous to wound healing.” It seems to me that the two statements are in direct contradiction. Over 1,500 personal injury claims have been filed against the Vitek bankruptcy, including mine. Does he believe that 1,500 patients failed to follow their physician’s instructions‘? I think not. I am enraged that Dr Homsy could blatantly blame thousands of innocent people for someone else’s mistake. I have personally had 15 TMJ surgeries as a direct result of Vitek’s implant and am personally acquainted with four other people who have also had multiple surgeries. The number of operations on these four people resulting from the Vitek implant is in excess of 65. I now have total, bilateral (Christensen type) prosthetic joints and one of my friends has had bilateral costochondral graft reconstruction. We are innocent victims whose lives have been destroyed by catastrophic health problems and insurmountable medical bills (many of which, I might add are not recoverable from our insurance companies) due to an inferior product. People like myself are not the cause of this problem, Dr Homsy. we are the result!
No FLAP ABOUT THIS PROCEDURE TO the Editor:--1 read with great pleasure the recent article authored by Drs Yih and Morita on management of large bony defects (J Oral Maxillofac Surg 48:689, 1991). I have been using this technique for the past 28 years, having published a case report in the September 1964 issue of the then Journal ofOral Surgery, and I believe it is surgically sound and an excellent procedure following removal of large cysts from the jaws. My only comment is that I like to have a wider base in the development of the osteoperiosteal flap. I also found that the osteoperiosteal flap is easily fractured at the base of the pedicle. To maintain the bone, I simply pack the defect with Gelfoam after the cavity is carefully debrided and irrigated with copious amounts of saline. I also wish to commend the editor for putting this article in the Journal. It seems as though sometimes the articles published are dedicated solely to orthognathic surgery and various other major surgical procedures. It is refreshing to we “oral surgeons in the field” to read articles written about procedures that are the “bread and butter” of our daily practice. MICHAELJ. SMIRNE.DDS Scranton, Pennsylvania THE PATIENT’S VIEWPOINT ON TMJ IMPLANTS
PAULA BEAULIEU. CDA, EFDA. EFODA Portland, Oregon FURTHER LESSONS ABOUT THE
TO the Editor:-1
would like to respond to the letter entitled “Reasons For Failure Of Proplast/Teflon Disc Replacements” (J Oral Maxillofac Surg 49:778, 1991) by Charles A. Homsy, ScD. former President of the defunct Vitek, Inc. Houston. Texas. I am personally offended by Dr Homsy’s letter, which basically put the blame of failure of the Vitek implant on the patients. To quote him directly, “Patients who fail to follow instructions to unload their joints have caused procedure failure.” If the failure of these implants is simply due to the inability of the patients to follow proper, postoperative instructions, why did the FDA issue a Safety Alert on May 16, 1990? I would like to quote from the FDA report dated January 15, 1991. “The ProplastiTeflon material is not substantially equivalent to Silastic. TMJ IPIs made from this material may fragment, delaminate or otherwise be damaged or punctured in a load bearing position. Debris in the joint from the implants can contribute to progressive bone degeneration of the condyle of the mandible and/or glenoid fossa and to foreign body response which could start in this area and be carried
PROPLAST-TEFLONTMJ IMPLANT To the Editor:--This letter comments on Dr John Kent’s letter “Important Lesson about Biomaterials in the TMJ” (J Oral Maxillofac Surg 49:442. 1991). Since he takes issue with Vitek’s testing of the ProplasUTeflon Interpositional Implant (PTIPI), I believe it is important to clarify his role in its development and marketing. In the 1970s Dr Kent worked jointly with Vitek in designing TMJ implants (condyles) and facial implants. His experience with the use of ProplastiTeflon laminations for TMJ disease began in 1974, when he used them as interpositional implants to restore lost vertical dimension following high condylectomy.’ His early impressions of the safety and efficacy of the laminations for this use were very encouraging. In his experience, no alternative implant material, such as silicone rubber sheeting or autogenous tissue, had proven satisfactory up to that time. In September of 1978, he joined with colleagues to report the clinical results of 1 to 4 years’ experience with the ProplastiTeflon laminations.2 His continued satisfactory use of the laminations was reported in September 19813 in a review of 81 patients who were treated over a 7-year period. By letter in early 1982 he reported analogous results of others” to Vitek. We discussed the previous wear testing, which showed the high resistance to wear of the Teflon FEP polymer used for articulation in the Proplast/Teflon laminates under the maximum expected load determined by using the Hylander and Smith data.’ Most importantly was what Dr Kent and other surgeons observed in those cases where the Proplast laminated to
1361
1362
Teflon FEP sheeting implants were removed or viewed on autopsy. He reported positive results and no problems related to these implants. I responded to Dr Kent’s letter on May 18, 1982 asking whether or not loads in the TMJ could be large, especially when there were occlusion abnormalities. Dr Kent and I talked numerous times over the rest of 1982 regarding the proposed Inter-positional Implant. He assured me that the TMJ was not loaded or only minimally loaded even in degenerative joint disease. Dr Kent was consulted in the development of the PTIPI shapes and he provided package insert information as to the indications, contraindications, and the suggested surgical procedure for the implant. As experience by other oral surgeons and Dr Kent indicated, appropriate modifications were made in the package insert. He served as our consultant during the entire period of sales of the PTIPI (1983 through June 1988). At the 1986 AAOMS annual meeting, some surgeons reported that in some patients with preoperative joint degeneration who were treated with meniscectomy and placement of the Proplast/Teflon lamination implant there was clear evidence of continuation of a degradation process that ultimately could, by mechanical abrasion of degenerated bone on the implant, lead to its mechanical disruption. Such damage seemed to elicit a tissue response that could be seen grossly at surgery and microscopically. At that time there were no previous reports on factors which predisposed patients to this sequence of continuing joint degeneration. A detailed letter reviewed by Dr Kent was sent to AAOMS in October 1986 regarding this matter. Vitek also organized a Round Table meeting in April 1987, including surgeons with both good and bad results. The findings, as agreed by the surgeons, were sent to the AAOMS in July 1987. Dr Kent was the leading author on two long-term retrospective reports on the use of Proplast implant material, both as an implant and as a coating on the metallic replacement for the TMJ condyle.6,7 These publications confirmed the 8 to lo-year safety and effectiveness of the material. Furthermore, he had participated in two workshops where experience with the interpositional use of Proplast/Teflon laminates in temporomandibular surgery was presented and reviewed by experienced oral surgeons from around the United States. These workshops generally confirmed the belief that the Proplast/Teflon laminate for use in the TMJ was suitable for that purpose. Dr Kent, during our association, recommended various tests and research to be done under his supervision at LSU. The studies included animal testing of the Pro-
LETTERS TO THE EDITOR
plast laminated to Teflon FEP in the TMJ that began in 1984. Vitek requested the results of that testing in early 1986 and was informed by Dr Kent that the testing data were not valid because of the inappropriate animal model. I decided to remove the PTIPI from the market in June 1988 as a result of a number of lawsuits that, because of the time consumed and the expense, made it uneconomical for a small company such as Vitek to manufacture and sell the implant, however helpful it might be to patients. Dr Kent continued to write the clinical information for the package insert until we made the decision to stop selling it. Vitek, of course, paid Dr Kent an appropriate royalty over the years for his codesigning the PTIPI and his being the clinical advisor for the implant. In 1984, the AAOMS “Criteria for Meniscus Surgery” stated that the surgical failure rate for all TMJ arthroplasty was approximately 10% to 20%. Claims filed against Vitek at the end of the filing period (March 1991), after publications and publicity regarding the PTIPI, amounted to less than 5% of the PTIPIs sold. CHARLES A. HOMSY, ScD
Houston,
Texas
References 1. Farrell CD, Kent JN: Clinical applications of Proplast in oral and maxillofacial surgery. Alpha Omegan 68, December:21-26, 1975 2. Dusek JJ, Kent J, Smith P: Proplast-Teflon implants for treatment of TMJ degenerate diseases. Case Reports and Outlines of Selected Scientific Sessions, Annual Meeting of the American Association of Oral and Maxillofacial Surgeons, Chicago, IL, September 1978 (abstr) 3. Malloy RB, Kent J, Smith P, Staples A: The treatment of TMJ arthroses with Proplast/Teflon implants. Case Reports and Outlines of Selected Scientific Sessions, 83rd Annual Meeting, American Association of Oral and Maxillofacial Surgeons, September 18-22, 1981 (abstr) 4. Kiersch TA: Proplast Teflon grafts for TMJ surgery. VIII International Conference on Oral Surgery, Berlin, West Germany, June 1983 (abstr) 5. Kent JN, Block MS, Homsy CA, et al: Experience with a polymer glenoid fossa prosthesis for partial or total temporomandibular joint reconstruction. J Oral Maxillofac Surg 44520, 1986 6. Kent JN, Misiek DJ, Akin RK, et al: Temporomandibular joint condylar prosthesis: A ten-year report. J Oral Maxillofac Surg 41:245, 1983 7. Kent JN, Westfall RL, Carlton DM: Chin and zygomaticomaxillary augmentation with Proplast: Long-term follow-up. Oral Surg 39:912, 1981-
xI”,_I”^___
J Oral Maxlllofac 49:1361-1362.
“__
_^~~^^“““_“__
Surg
1991
throughout the immune system.” Dr Homsy’s letter references “foreign-body reaction” as being “a biological response directly analogous to wound healing.” It seems to me that the two statements are in direct contradiction. Over 1,500 personal injury claims have been filed against the Vitek bankruptcy, including mine. Does he believe that 1,500 patients failed to follow their physician’s instructions‘? I think not. I am enraged that Dr Homsy could blatantly blame thousands of innocent people for someone else’s mistake. I have personally had 15 TMJ surgeries as a direct result of Vitek’s implant and am personally acquainted with four other people who have also had multiple surgeries. The number of operations on these four people resulting from the Vitek implant is in excess of 65. I now have total, bilateral (Christensen type) prosthetic joints and one of my friends has had bilateral costochondral graft reconstruction. We are innocent victims whose lives have been destroyed by catastrophic health problems and insurmountable medical bills (many of which, I might add are not recoverable from our insurance companies) due to an inferior product. People like myself are not the cause of this problem, Dr Homsy. we are the result!
No FLAP ABOUT THIS PROCEDURE TO the Editor:--1 read with great pleasure the recent article authored by Drs Yih and Morita on management of large bony defects (J Oral Maxillofac Surg 48:689, 1991). I have been using this technique for the past 28 years, having published a case report in the September 1964 issue of the then Journal ofOral Surgery, and I believe it is surgically sound and an excellent procedure following removal of large cysts from the jaws. My only comment is that I like to have a wider base in the development of the osteoperiosteal flap. I also found that the osteoperiosteal flap is easily fractured at the base of the pedicle. To maintain the bone, I simply pack the defect with Gelfoam after the cavity is carefully debrided and irrigated with copious amounts of saline. I also wish to commend the editor for putting this article in the Journal. It seems as though sometimes the articles published are dedicated solely to orthognathic surgery and various other major surgical procedures. It is refreshing to we “oral surgeons in the field” to read articles written about procedures that are the “bread and butter” of our daily practice. MICHAELJ. SMIRNE.DDS Scranton, Pennsylvania THE PATIENT’S VIEWPOINT ON TMJ IMPLANTS
PAULA BEAULIEU. CDA, EFDA. EFODA Portland, Oregon FURTHER LESSONS ABOUT THE
TO the Editor:-1
would like to respond to the letter entitled “Reasons For Failure Of Proplast/Teflon Disc Replacements” (J Oral Maxillofac Surg 49:778, 1991) by Charles A. Homsy, ScD. former President of the defunct Vitek, Inc. Houston. Texas. I am personally offended by Dr Homsy’s letter, which basically put the blame of failure of the Vitek implant on the patients. To quote him directly, “Patients who fail to follow instructions to unload their joints have caused procedure failure.” If the failure of these implants is simply due to the inability of the patients to follow proper, postoperative instructions, why did the FDA issue a Safety Alert on May 16, 1990? I would like to quote from the FDA report dated January 15, 1991. “The ProplastiTeflon material is not substantially equivalent to Silastic. TMJ IPIs made from this material may fragment, delaminate or otherwise be damaged or punctured in a load bearing position. Debris in the joint from the implants can contribute to progressive bone degeneration of the condyle of the mandible and/or glenoid fossa and to foreign body response which could start in this area and be carried
PROPLAST-TEFLONTMJ IMPLANT To the Editor:--This letter comments on Dr John Kent’s letter “Important Lesson about Biomaterials in the TMJ” (J Oral Maxillofac Surg 49:442. 1991). Since he takes issue with Vitek’s testing of the ProplasUTeflon Interpositional Implant (PTIPI), I believe it is important to clarify his role in its development and marketing. In the 1970s Dr Kent worked jointly with Vitek in designing TMJ implants (condyles) and facial implants. His experience with the use of ProplastiTeflon laminations for TMJ disease began in 1974, when he used them as interpositional implants to restore lost vertical dimension following high condylectomy.’ His early impressions of the safety and efficacy of the laminations for this use were very encouraging. In his experience, no alternative implant material, such as silicone rubber sheeting or autogenous tissue, had proven satisfactory up to that time. In September of 1978, he joined with colleagues to report the clinical results of 1 to 4 years’ experience with the ProplastiTeflon laminations.2 His continued satisfactory use of the laminations was reported in September 19813 in a review of 81 patients who were treated over a 7-year period. By letter in early 1982 he reported analogous results of others” to Vitek. We discussed the previous wear testing, which showed the high resistance to wear of the Teflon FEP polymer used for articulation in the Proplast/Teflon laminates under the maximum expected load determined by using the Hylander and Smith data.’ Most importantly was what Dr Kent and other surgeons observed in those cases where the Proplast laminated to
1361
1362
Teflon FEP sheeting implants were removed or viewed on autopsy. He reported positive results and no problems related to these implants. I responded to Dr Kent’s letter on May 18, 1982 asking whether or not loads in the TMJ could be large, especially when there were occlusion abnormalities. Dr Kent and I talked numerous times over the rest of 1982 regarding the proposed Inter-positional Implant. He assured me that the TMJ was not loaded or only minimally loaded even in degenerative joint disease. Dr Kent was consulted in the development of the PTIPI shapes and he provided package insert information as to the indications, contraindications, and the suggested surgical procedure for the implant. As experience by other oral surgeons and Dr Kent indicated, appropriate modifications were made in the package insert. He served as our consultant during the entire period of sales of the PTIPI (1983 through June 1988). At the 1986 AAOMS annual meeting, some surgeons reported that in some patients with preoperative joint degeneration who were treated with meniscectomy and placement of the Proplast/Teflon lamination implant there was clear evidence of continuation of a degradation process that ultimately could, by mechanical abrasion of degenerated bone on the implant, lead to its mechanical disruption. Such damage seemed to elicit a tissue response that could be seen grossly at surgery and microscopically. At that time there were no previous reports on factors which predisposed patients to this sequence of continuing joint degeneration. A detailed letter reviewed by Dr Kent was sent to AAOMS in October 1986 regarding this matter. Vitek also organized a Round Table meeting in April 1987, including surgeons with both good and bad results. The findings, as agreed by the surgeons, were sent to the AAOMS in July 1987. Dr Kent was the leading author on two long-term retrospective reports on the use of Proplast implant material, both as an implant and as a coating on the metallic replacement for the TMJ condyle.6,7 These publications confirmed the 8 to lo-year safety and effectiveness of the material. Furthermore, he had participated in two workshops where experience with the interpositional use of Proplast/Teflon laminates in temporomandibular surgery was presented and reviewed by experienced oral surgeons from around the United States. These workshops generally confirmed the belief that the Proplast/Teflon laminate for use in the TMJ was suitable for that purpose. Dr Kent, during our association, recommended various tests and research to be done under his supervision at LSU. The studies included animal testing of the Pro-
LETTERS TO THE EDITOR
plast laminated to Teflon FEP in the TMJ that began in 1984. Vitek requested the results of that testing in early 1986 and was informed by Dr Kent that the testing data were not valid because of the inappropriate animal model. I decided to remove the PTIPI from the market in June 1988 as a result of a number of lawsuits that, because of the time consumed and the expense, made it uneconomical for a small company such as Vitek to manufacture and sell the implant, however helpful it might be to patients. Dr Kent continued to write the clinical information for the package insert until we made the decision to stop selling it. Vitek, of course, paid Dr Kent an appropriate royalty over the years for his codesigning the PTIPI and his being the clinical advisor for the implant. In 1984, the AAOMS “Criteria for Meniscus Surgery” stated that the surgical failure rate for all TMJ arthroplasty was approximately 10% to 20%. Claims filed against Vitek at the end of the filing period (March 1991), after publications and publicity regarding the PTIPI, amounted to less than 5% of the PTIPIs sold. CHARLES A. HOMSY, ScD
Houston,
Texas
References 1. Farrell CD, Kent JN: Clinical applications of Proplast in oral and maxillofacial surgery. Alpha Omegan 68, December:21-26, 1975 2. Dusek JJ, Kent J, Smith P: Proplast-Teflon implants for treatment of TMJ degenerate diseases. Case Reports and Outlines of Selected Scientific Sessions, Annual Meeting of the American Association of Oral and Maxillofacial Surgeons, Chicago, IL, September 1978 (abstr) 3. Malloy RB, Kent J, Smith P, Staples A: The treatment of TMJ arthroses with Proplast/Teflon implants. Case Reports and Outlines of Selected Scientific Sessions, 83rd Annual Meeting, American Association of Oral and Maxillofacial Surgeons, September 18-22, 1981 (abstr) 4. Kiersch TA: Proplast Teflon grafts for TMJ surgery. VIII International Conference on Oral Surgery, Berlin, West Germany, June 1983 (abstr) 5. Kent JN, Block MS, Homsy CA, et al: Experience with a polymer glenoid fossa prosthesis for partial or total temporomandibular joint reconstruction. J Oral Maxillofac Surg 44520, 1986 6. Kent JN, Misiek DJ, Akin RK, et al: Temporomandibular joint condylar prosthesis: A ten-year report. J Oral Maxillofac Surg 41:245, 1983 7. Kent JN, Westfall RL, Carlton DM: Chin and zygomaticomaxillary augmentation with Proplast: Long-term follow-up. Oral Surg 39:912, 1981-
