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Dermal Fillers like Restylane and Perlane placed expertly along with wrinkle treatments are now a normal part of image maintenance. Wrinkle reduction made easy.

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  1. 1. Patients with adverse reactions to subcutaneousinjection of Aquamid (polyacrylamide hydrogel) Lise Christensen, MD, Senior pathologist Rigshospitalet, Copenhagen, Denmark
  2. 2. Polyacryl amide hydrogel (PAAG) A gel consisting of a backbone of approximately 2.5 % cross- linked polyacrylamide and 97.5 % watersoft contact lenses, opthalmic surgery, packaging agentin food, clarification agent for sugar juices , in waterpurificationHas been used in plastic and aesthetic surgery in the formerSoviet Union for more than 15 years and in Europe for 7 yearsExcellent plasticity, widely atoxic and non-immunogenic
  3. 3. Normal host response to foreign material1. 24 hours: neutrophils and small round cells predominate2. 48 hours: monocytes predominate – no neutrophils from now on3. 7 days: early formation of foreign-body giant cells occur4. 2 weeks: the cellular response remains mild5. 4 weeks: monocytes diff. into epitheloid cells, fibroblasts appear6. 6 weeks: foreign-body giant cells common, increase of coll. deposition7. 8 weeks: chronic inflammatory cells and a heavy collagen deposition8. 6 months: stable giant cell and low-grade cellular response along with a reduced amount of more dense collagen and the conversion of fibroblasts into fibrocytes
  4. 4. Heavy for eign bodyr esponse in cheektissue after 2 monthsNo gr anulocytesNo clinical symptoms
  5. 5. PA A G (A quamid) infr ont tissue (glabella)after 7½ months.
  6. 6. After 2 years.Hardly any cellular reaction
  8. 8. Adverse reactions
  9. 9. It is common to see some swelling about 10days after Aquamid injection. This swelling isprobably due to a tissue response to the gel inorder to reach a steady-state.This swelling disappears spontaneously after12-13 daysClassical signs of infection are not present(warmth, pulsation, pain and redness)
  10. 10. Generalised adverse reactions 1. Allergic/hypersensitivity reactions (rash, Quinckes oedema, anaphylactic chok) 2. Autoimmune reactions (collagenoses- LED, rheum arthr. lung fibrosis, PBC, Mb Graves, atherosclerosis etc)Local or regional adverse reactions1. Short-term reactions: pain, oedema, pruritus, ecchymosis, pigmentation changes, excessive elevation and embolism, if gel is accident.injected into the vascular system appear within 2 days of the injection and disappear spontaneously within 1-2 weeks. Pruritus subside within weeks or months2. Long-term reactions: inflammatory nodule (clinically a granuloma) appear after weeks, months or years and present as a tender nodule and/or Swelling and redness at the point of injection. Later this may lead to fistulation, ulceration, discharge of pus and/or filler material and tissue destruction.
  11. 11. Inflammatory noduleCharacterised by polymorphnucleargranulocytes and microorganisms (bacteria)– which may be difficult to detect –As well as the foreign-body reaction whichis seen in all tissues injected with a foreignmaterial.
  12. 12. Adverse reaction, 6 weeksGranulomatous inflamm.
  13. 13. Injection techniqueSterility precautions should be as in open surgery:1. Gloves, mask, hut2. Skin disinfection of injection site3. Retraction of injection needle as prescribed4. Tell patient to refrain from activities increasing risk of contamination with micro-organisms for 8 hours after the injection
  14. 14. Incidence of Microorganisms in Human tissueCultures taken from breast tissue far away from the papillaand not previously operated upon have shown a 53% positivityfor coagulase-negative staphylococci. Propionibacterium acne wasthe most frequently found anaerobic bacterium (Thornton, 88).Cultures from 389 periprosthetic breast tissues with no clinicalsigns of infection have shown 23.5 % microorganisms includingaerobic and anaerobic bacteria as well as fungi and other organisms(Netscher, 95),
  15. 15. We all harbour bacteria within out tissues. Ourimmune system take care of them.Patients with long-term antibiotic treatment fordifferent diseases (colitis ulcerosa, Mb. Crohn, DM)may grow antibiotic-resistant bacterial strainsPatients on long-term steroid or NSAID treatment(collagenoses) have a reduced immune system.
  16. 16. 1. Aquamid should be treated like any other implant(heart valves, artificial blood vessels, breast siliconeprostheses and hip replacement prostheses).The local immune defence is reduced2. In case of sepsis(e.g. tooth extraction, pneumonia, abdominal surgery)antibiotic treatment should be given
  17. 17. A negative tissue culture is no proofthat microorganisms are not presentA negative GRAM or PAS stain onmicroscopy of a cell smear or tissue section is noproof that microorganisms are not presentAntibiotic therapy prior to a culture swapor biopsy may immobilize or reduce the numberof microorganisms hindering their detection
  18. 18. Report on 56 cases of adverse events out of 40.000patients injected with Aquamid (1.4 ‰)Information from treating physicists and patients on filled-inpre-printed forms distributed by and sent to the manufacturerNumber of patients: 56Patient age (75%): 23-60 years - mean 44, median 45
  19. 19. Study period: May 21. 2001 to September 15. 2003Contributing countries:Australia (9 pt.s), Austria (4 pt.s), Belgium (1 pt.),Brazil (5 pt.s), Equador (1 pt.), France (7 pt.s),Germany (7 pt.s), Holland (3 pt.s), Israel (1 pt), Italy(7 pt.s), New Zealand (1 pt), Spain (6 pt.s), Sweden (1pt), Switzerland (2 pt.s), USA (1 pt.)
  20. 20. Injection sites:Lip 32Naso-labial folds 24Glabella 5Cheekbone 4Cheek 2Chin 2Forearm, allergy test 2Nosetip 1
  21. 21. Type of physician:Plastic surgeon 23Dermatologist 12Aesthetic/cosmetic doctor 20Unknown 1Symptoms: Swelling, redness, pain, fistulation, pusdischargeSymptom delay (Time from last injection to first symptomof adverse reaction: median 12 days.
  22. 22. Established causes of adverse reactions (found in 18 (32%) of patients)Bacteria Herpes labialis1. Positive culture 5 casesStreptococci viridans: 3 cases Too superficially injectedAtypical mycobacteriae: 1 case 2 cases2. DNA cloningShigella 1 case Palsy 1 caseStreptococci viridans 1 case3. Microscopy (gram stain)Gram positive cocci 2 cases Breast cancer subsequentlyGram positive rods 1 case . 1 caseTotal: 9 cases
  23. 23. Known contraindications:Several previous injections at the same site: 9 patientsMb. Crohn and Colitis Ulcerosa: 2 patientsPemphigus: 1 patientInsulin dependent Diabetes Mellitus: 1 patientDentistry at the injection site: 1 patientFace-lift just prior to injection: 1 patientOral sex right after injection: 1 patientMake-up during injection: 1 patient
  24. 24. First line Treatment:None: 6 patientsAntibiotic alone: 10 patientsAntibiotic+steroid: 13 patientsAntibiotic+steroid+NSAID: 7 patientsSteroid: 6 patientsNSAID: 6 patientsAnti-histamine: 4 patientsDrainage only: 4 patientsTotal 56 patients
  25. 25. Second line treatment: 32 patientsAntibiotic: 29 patientsSteroid: 3 patientsThird line treatment 8 patientsAntibiotic: 8 patients___________________________________________________Primary treatment .Steroid + weak antibiotic: 2 patientsSteroid alone: 2 patientsSteroid + NSAID and/or antihistamine 3 patientsAntihistamine 1 patientThey all received antibiotics the third time with improvement or completerecovery.
  26. 26. Fastest recovery was obtained for those patients treatedwith antibiotics from the start - in spite of negative findingson culture and/or microscopy.A prolonged course resulted if primary (antibiotic)treatment was delayed/weak or if it included steroids orNSAIDs.Anti-histamines or anti-viral drugs did not hinder recovery.
  27. 27. Cause of adverse reactions Bacteria, sometimes preceded by herpesTreatment of adverse reactionsAntibiotics in high dosage i.m. or i.v.– steroidsor NSAIDs are stongly contraindicated
  28. 28. Treatment of adverse inflammatory reactions:Immediate administration of a broad-spectered antibiotic in high dosage, e.g.:1. Fluoroquinolon (Ciproxin) 500 mg x 2 for up to 7 days2. Vancomycin/Teicomycin, i.m. 1 g x 2 , or Lincomycin 300 mg x 2 for 2 days followed by ½ dosis for the next 10-20 days.*Tell patient to go to injecting doctor for treatment and show patience