TMD Background History of TMJ Implants
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1 2017 MDEpiNet PPP Annual meeting TMD Background History of TMJ Implants Terrie Cowley - President & Co-founder The TMJ Association, Ltd.
2 The TMJ Association The TMJ Association is a patient advocacy organization to improve the healthcare and life for everyone affected by TMD. Founded in 1986 based in Milwaukee, WI
3 Manifestation of TMD Pain in the chewing muscles of the face Same conditions that affect other joints in the body affect the TMJ 36+ million people in the U.S. are affected
4 TMD Does Not Exist Alone Chronic TMD is a complex medical condition a multisystem disorder with overlapping comorbidities mediated by genes, sex, age, behavioral, environmental/epigenetic triggers.
5 Treatments/Costs A 1992 study estimated the annual cost of TMJ treatments to be $32 billion (J. Fricton et al. 1992). There is not one drug or biologic labeled for TMD. There are a multitude of treatments available to TMD patients many off-label and lacking evidence. Patients are treated by an array of different professionals who do not work as a team. There is no specialty for TMD Patients can improve. Patients can be unaffected. Patients can be worsened. Without knowing what will happen to me (risk:benefit), we call this TMJ Russian Roulette.
6 TMJ Implant History 1980s Interpositional Implants o Dacron reinforced Silastic Sheeting o 1982 FDA approves Vitek Teflon coated Proplast 1990 FDA issued Class I Recall of Vitek implant and seized all products open communication to brain. Vitek President moved patents off shore, fled to Switzerland, and resumed business Congressional Hearing: Are FDA and NIH Ignoring the Dangers of TMJ (Jaw) Implants? 1993 Dow Corning discontinued labeling Silastic sheeting for TMJ trismus. Still used off label.
7 TMJ Total Joint Devices 1999 FDA approves TMJ Concepts device 2001 FDA approves TMJ Implants, Inc. device (MoM) 2002 FDA approves Biomet/Walter Lorenz device 2007 GAO Report FDA Concerns FDA management indicated that the clinical data was not expected to be of high quality because the sponsor was a small manufacturer. Either good engineering data or good clinical data was acceptable to approve a device - not necessarily both. Further in the report both were found to be inadequate FDA Issues 522 Order Following an analysis of MedWatch complaints from 2004 to 2010 found 52% of the devices had to be explanted before three years.
8 Patient Reported Outcomes Adverse Events at Time of Surgery Transient ischemic attack (TIA) Stroke Traumatic brain injury (TBI) Facial paralysis Tachycardia, bradycardia Death
9 Device-related Adverse Events Perforations of device into the skull, ear or skin Loose or broken screws Device fracture Device particulation Device migration (components and particulate)
10 abnormal thyroid function Long-Term Adverse Outcomes allergy hives, rashes itching bite changes bladder dysfunction bone degeneration Chronic Fatigue device materials leaching into tissues & blood stream dizziness, balance issues drooling dyslexia dystonic tremor ear pain, diminished or hearing loss, hyperacusis eye lid paralysis necessitating gold leaf implant or suturing eye lids together face unrecognizable after surgery chronic, continuous headaches migraine, tension-type, other Fibromyalgia, Myofascial Pain Dysfunction, muscle aches and various chronic respiratory, urinary tract, pelvic, types of pain in the head, neck and upper or gastrointestinal infections back. cognitive dysfunction and memory issues flu-like symptoms cold extremities foreign body giant cell reaction constant low-grade fever harvest site issues (butt, abdomen, rib, decreased jaw range of motion ear cartilage, muscle, rib, toe, etc.)
11 Adverse Events (cont.) heterotopic bone growth and ankyloses hoarseness infections not responsive to antibiotics intolerance to heat and/or cold lymphadenopathy MS-like symptoms metal sensitivity and allergies metalosis muscle atrophy muscle spasms night sweats numbness that does not alleviate over time paralysis that does not recover over time parotid gland cysts, stones pelvic gastrointestinal infections post-traumatic stress syndrome seizures Sjogren s; dry eyes and dry mucous membranes skin discoloration sleep apnea or sleep disorders snow blindness, blurred vision, dyslexia speech difficulty stroke swallowing difficulties swelling that does not subside traumatic brain injury teeth breaking during and after the procedure urinary tract issues
12 Patient-Reported Outcome Evaluation Co-chairs: Joel Gagnier, Assistant Professor, Department of Orthopaedic Surgery, Department of Epidemiology, School of Public Health, University of Michigan. Tricia Kalinowski, TMJ Patient Goals: (1) to develop outcome assessment and reporting tools based on patient input, and (2) to develop evidence to incorporate patient-centered data into clinical care Responsibilities: (1) identify available validated PRO instruments that include patient quality of life for the evaluation TMJ treatments, such as device implants, and (2) to develop valid instruments to gather PROs as needed
13 Real-World Evidence & Patient Data Co-chairs: Carolina Alvarez-Garriga, Division of Epidemiology, CDRH Michele Kaseta, TMJ Patient Goal: to develop evidence based best practices, treatment protocols and clinical practice guidelines which will include patient-centered data Responsibilities: (1) summarize current recommended therapies and identify adverse events due to implants through patient reported surveys outside of the clinical trial reporting environment, and (2) coordinate with input from the other three TMJ working groups
14 Listening to the Patient s Voice Patients view their treatment and outcomes differently than their doctors The TMJ association has collected testimonials from thousands of patients who want to be heard so that others do not have to have the same experience One working group is dedicated to understanding what scientifically-valid instruments and data are available to translate patient experience into actionable information Our partnership has begun a systematic review published data in order to identify the best way to collect patientcentered data in a way that is meaningful to doctors in delivering customized treatment
15 Introducing Lisa
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