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Teflon — Polytetrafluoroethylene (PTFE / Polytef)

Polytef paste (PTFE / Teflon) was the first injectable bulking agent ever used in urology, pioneered by Victor Politano in 1964 for female urinary incontinence and adapted by Prem Puri in 1981 for endoscopic correction of vesicoureteral reflux (the original STING procedure).[1][7][8] It was never FDA-approved for urologic use and has been largely abandoned worldwide after the discovery of distant particle migration to the lungs, brain, lymph nodes, kidneys, and spleen.[2]

Composition & Material Properties​

  • Chemical: polytetrafluoroethylene — (C₂F₄)ₙ; produced by pyrolysis of Teflon.[1]
  • Formulation: PTFE particles in glycerine + polysorbate carrier.
  • Particle size: heterogeneous, 3–100 μm — critically, a substantial fraction is < 50 μm and phagocytosable by macrophages.[4][5]
  • Nonbiodegradable; non-immunogenic (no skin test required).
  • Hydrophobic: serum proteins bind instantly and are denatured at the particle surface, amplifying foreign-body response — especially for smaller particles.[5]

The wide particle size distribution — including a phagocytosable fraction — is the design flaw that distinguishes PTFE from all later-generation bulking agents (Macroplastique > 100 μm, Durasphere 212–500 μm, Coaptite 75–125 μm).[2][4]

Historical Development​

  • 1964 — Victor Politano (Miami): first use of an injectable bulking agent for female SUI. 128-patient series accumulated 1964–1991.[7]
  • 1974 — first formal publication of periurethral PTFE for SUI.
  • 1981 — Prem Puri (Dublin) adapts the technique for VUR: the STING (Subureteral Transurethral INjection) procedure — the acronym persists today even though the material has been replaced.[8][9]
  • 1984 — Malizia JAMA documents distant particle migration in animals.[2]
  • 1984–2003 — continued European/non-US use despite migration concerns; Puri's group accumulates > 12,000 ureters.[10][11]
  • Late 1990s–2000s — progressively replaced by Deflux (FDA 2001) and Contigen/Macroplastique/Bulkamid for SUI; clinical use largely abandoned.[1][3]

Mechanism​

Permanent, nonbiodegradable bulking at the injection site. After injection a foreign-body giant-cell granulomatous reaction develops around the PTFE particles; the paste undergoes diffuse interstitial splitting with multinucleated giant cells, macrophages, and increased collagen deposition.[4][12]

Injection Technique​

For Female SUI[6][7][13]​

  • Local or brief GA/spinal; outpatient ~30 min.
  • Periurethral or transurethral under cystoscopic guidance.
  • 18-G needle or 14F angiocatheter.
  • Large volumes: 5–20 cc per session; cumulative 16–85 mL across multiple injections.
  • Lotenfoe modified technique (paste heating + 3–5 d suprapubic catheter) improved cure 11% → 39%.

For VUR — STING[8][9]​

  • GA in children; ~15 min day-case.
  • Very small volumes (< 1 mL).
  • Needle at 6 o'clock below the ureteral orifice; "volcano-mound" elevation.

Clinical Efficacy​

Female SUI​

StudynFollow-upOutcome
Lopez / Politano 1993128 (1964–1991)31 mo mean73% improved, 54.3% totally dry.[7]
Herschorn / Glazer 20004615.9 mo30.4% dry, 41.3% improved; probability of remaining dry 90% at 1 yr → 60% at 2 yr.[6]
Lotenfoe 199321 (type III)11.4 moStandard 11% / modified 39% cure.[13]
Kiilholma 1993225 yrOnly 18% cure.[15]

Male Post-Prostatectomy​

Notably poor:[14][16][17]

  • Kabalin 1994 (n = 13): only 23% improved; none dry; 16–23 cc per session.
  • Stanisic 1991 (n = 20): 35% long-term improvement; only 20% would recommend.

Pediatric VUR — The Largest Bulking-Agent Experience​

Studyn (ureters)Follow-upOutcome
Puri / Granata 1998 multicenter survey12,251 (8,332 children, 41 centers)1–13 yr75.3% resolved after 1 injection; 12% after 2; 4.5% failure → reimplantation; 0.33% VUJ obstruction; 2.8% recurrence.[10]
Chertin 2002 long-term393 (258 children)11–17 yr76.8% after 1 injection; 95% remain reflux-free at 11–17 yr; 5% recurrence (mostly low grade).[18]
Chertin 2003 high-grade717 (526 children, grade IV–V)11.6 yr median58% after 1; 84% after 1–3 injections; 1.2% recurrence.[11]
Puri 1995 infants75 (52 infants)1–9 yr65% after 1; 93% remain reflux-free.[9]
Yücel 200748 (38 patients)12.5 yr mean73% remain reflux-free; 27% recurrence (median 2 yr; mostly grade IV–V).[19]

The Migration Problem — The Defining Safety Concern​

Malizia 1984 (JAMA)[2]​

Pivotal animal study after periurethral PTFE injection in dogs and monkeys:

  • 50–70 d: particles in pelvic lymph nodes 6/7, lungs 4/7.
  • 10.5 mo: particles in pelvic lymph nodes, lungs, and brain 7/7; kidneys 4/7; spleen 2/7.
  • X-ray microanalysis confirmed PTFE.
  • Polytef granulomas at injection sites and at some distant migration sites.
  • Conclusion: until long-term human effects are known, polytef paste should not be used in children or young adults with normal life expectancy.

Confirmatory Studies​

  • Aaronson 1993: PTFE migration to lungs and brain within 2 weeks in animals; brain particles up to 15 μm — pulmonary bed an "inefficient filter." Stated the data are a contraindication to use in children.[20]
  • Vandenbossche 1993: PTFE particles in rabbit lungs after bladder submucosal injection.[21]
  • Claes 1989: First human case of clinically significant pulmonary migration after periurethral PTFE.[22]
  • Aragona 1997: Giant granuloma + pelvic lymph node adenopathy with heavy multinucleated foreign-body reaction in all 3 children who underwent open surgery after failed STING.[23]

The mechanism — phagocytosable small particles entering lymphatic and venous channels — directly drove the engineering of all subsequent bulking agents above the 80–100 μm phagocytosis threshold.

Local Complications — "Teflonoma"​

Foreign-body granuloma surrounding PTFE particles:[12][24][25][26]

  • Periurethral teflonoma with bladder outlet obstruction — McKinney case 9 years after injection; obstructing mass was "almost totally composed of foreign-body giant-cell response to PTFE."[12]
  • Complete urinary obstruction from granulomatous reaction (Boykin).[24]
  • Periurethral granuloma with urethral wall prolapse, periurethral abscess, urethral diverticulum, Teflon cyst, perineal migration with pain, periurethral fistula.[15][25]
  • VUJ obstruction in 0.33% (41/12,251 ureters) requiring reimplantation.[10]

Laryngeal Teflonomas (ENT)​

PTFE was also widely used for vocal fold medialization with parallel complications:[26][27][28][29][30]

  • Wenig 1990: 8 cases of laryngeal/neck teflonomas clinically simulating malignancy.[26]
  • Giant Teflon granuloma → airway obstruction and persistent dysphonia.[28]
  • Varvares: dysphonia from overinjection, malposition, or the proliferative granulomatous response — deficits persist despite corrective procedures.[29]
  • Nakayama 1993: review of 28 failures concluded "the success and safety of this treatment have been overstated."[30]

Long-Term Durability​

VUR: 95% reflux-free at 11–17 years in Puri's series[18]; 27% recurrence at 12.5 years in Yücel — higher in grade IV–V.[19] Oberritter: disappearance of the Teflon deposit on ultrasound was tightly associated with VUR recurrence.[31]

SUI: poor — 18% cure at 5 yr (Kiilholma); 90% → 60% dry probability over 1 → 2 yr (Herschorn).[15][6]

Regulatory Status​

  • Never FDA-approved for urologic use.[1][32]
  • Used extensively in Europe and elsewhere without formal approval in many jurisdictions.
  • FDA refusal based on Malizia migration data and subsequent reports.[2]
  • PTFE is approved for unrelated applications (e.g., ePTFE vascular grafts) — the injectable particulate paste was never approved for soft-tissue augmentation.
  • Clinical use largely abandoned worldwide.[1][3]

Legacy & Historical Significance​

PTFE holds an irreplaceable position in the history of bulking agents:[1][2][7][8][10]

  • First injectable urologic bulking agent (1964) — created the field.
  • First agent used for endoscopic VUR correction (1981) — the STING procedure remains the basis of all endoscopic VUR treatment.
  • Largest VUR experience of any agent (> 12,000 ureters).
  • Longest follow-up (17 years).
  • Drove the engineering of all later bulking agents above the 80–100 μm phagocytosis threshold.
  • The term "STING" persists in nomenclature today.

Reconstructive-Urology Relevance​

Contemporary relevance is largely forensic: adult patients with prior pediatric STING may present with:

  • Imaging abnormalities (PTFE deposits, calcified pelvic lymph nodes) of unclear significance.
  • Late teflonoma with bladder outlet obstruction (case reports up to 9 years out).[12]
  • Recurrent VUR requiring definitive reimplantation.

See also: Contigen, Deflux, Macroplastique, Historical Bulking Agents.

References​

1. Kirchin V, Page T, Keegan PE, et al. Urethral Injection Therapy for Urinary Incontinence in Women. Cochrane Database of Systematic Reviews. 2017;7:CD003881. doi:10.1002/14651858.CD003881.pub4

2. Malizia AA, Reiman HM, Myers RP, et al. Migration and Granulomatous Reaction After Periurethral Injection of Polytef (Teflon). JAMA. 1984;251(24):3277-3281.

3. Tullus K. Vesicoureteric Reflux in Children. Lancet. 2015;385(9965):371-379. doi:10.1016/S0140-6736(14)60383-4

4. Petrozza V, Carpino F, Ricci M, Anceschi C, Melis M. Structural and Ultrastructural Modifications Following Transurethral Injection of Teflon Paste. Histology and Histopathology. 1988;3(3):279-282.

5. Zardeneta G, Mukai H, Marker V, Milam SB. Protein Interactions With Particulate Teflon: Implications for the Foreign Body Response. Journal of Oral and Maxillofacial Surgery. 1996;54(7):873-878. doi:10.1016/s0278-2391(96)90540-6

6. Herschorn S, Glazer AA. Early Experience With Small Volume Periurethral Polytetrafluoroethylene for Female Stress Urinary Incontinence. The Journal of Urology. 2000;163(6):1838-1842.

7. Lopez AE, Padron OF, Patsias G, Politano VA. Transurethral Polytetrafluoroethylene Injection in Female Patients With Urinary Continence. The Journal of Urology. 1993;150(3):856-858. doi:10.1016/s0022-5347(17)35632-x

8. Puri P. Endoscopic Correction of Primary Vesicoureteric Reflux by Subureteric Injection of Polytetrafluoroethylene. Lancet. 1990;335(8701):1320-1322. doi:10.1016/0140-6736(90)91197-i

9. Puri P, Palanimuthu M, Dass L. Endoscopic Treatment of Primary Vesicoureteric Reflux in Infants by Subureteric Injection of Polytetrafluoroethylene. A 9-Year Follow-Up. European Urology. 1995;27(1):67-70. doi:10.1159/000475127

10. Puri P, Granata C. Multicenter Survey of Endoscopic Treatment of Vesicoureteral Reflux Using Polytetrafluoroethylene. The Journal of Urology. 1998;160(3 Pt 2):1007-1011. doi:10.1097/00005392-199809020-00011

11. Chertin B, De Caluwé D, Puri P. Endoscopic Treatment of Primary Grades IV and V Vesicoureteral Reflux in Children With Subureteral Injection of Polytetrafluoroethylene. The Journal of Urology. 2003;169(5):1847-1849. doi:10.1097/01.ju.0000062300.71507.3a

12. McKinney CD, Gaffey MJ, Gillenwater JY. Bladder Outlet Obstruction After Multiple Periurethral Polytetrafluoroethylene Injections. The Journal of Urology. 1995;153(1):149-151. doi:10.1097/00005392-199501000-00053

13. Lotenfoe R, O'Kelly JK, Helal M, Lockhart JL. Periurethral Polytetrafluoroethylene Paste Injection in Incontinent Female Subjects: Surgical Indications and Improved Surgical Technique. The Journal of Urology. 1993;149(2):279-282. doi:10.1016/s0022-5347(17)36056-1

14. Kabalin JN. Treatment of Post-Prostatectomy Stress Urinary Incontinence With Periurethral Polytetrafluoroethylene Paste Injection. The Journal of Urology. 1994;152(5 Pt 1):1463-1466. doi:10.1016/s0022-5347(17)32446-1

15. Kiilholma PJ, Chancellor MB, Makinen J, Hirsch IH, Klemi PJ. Complications of Teflon Injection for Stress Urinary Incontinence. Neurourology and Urodynamics. 1993;12(2):131-137. doi:10.1002/nau.1930120206

16. Stanisic TH, Jennings CE, Miller JI. Polytetrafluoroethylene Injection for Post-Prostatectomy Incontinence: Experience With 20 Patients During 3 Years. The Journal of Urology. 1991;146(6):1575-1577. doi:10.1016/s0022-5347(17)38170-3

17. Corrie D, Rodriguez FR, Thompson IM. Periurethral Polytetrafluoroethylene Injections for Post-Prostatectomy Incontinence. Military Medicine. 1989;154(9):442-444.

18. Chertin B, Colhoun E, Velayudham M, Puri P. Endoscopic Treatment of Vesicoureteral Reflux: 11 to 17 Years of Followup. The Journal of Urology. 2002;167(3):1443-1445. doi:10.1016/s0022-5347(05)65340-2

19. Yücel S, Tarcan T, Simşek F. Durability of a Single Successful Endoscopic Polytetrafluoroethylene Injection for Primary Vesicoureteral Reflux: 14-Year Followup Results. The Journal of Urology. 2007;178(1):265-268. doi:10.1016/j.juro.2007.03.060

20. Aaronson IA, Rames RA, Greene WB, et al. Endoscopic Treatment of Reflux: Migration of Teflon to the Lungs and Brain. European Urology. 1993;23(3):394-399. doi:10.1159/000474637

21. Vandenbossche M, Delhove O, Dumortier P, Deneft F, Schulman CC. Endoscopic Treatment of Reflux: Experimental Study and Review of Teflon and Collagen. European Urology. 1993;23(3):386-393. doi:10.1159/000474636

22. Claes H, Stroobants D, Van Meerbeek J, et al. Pulmonary Migration Following Periurethral Polytetrafluoroethylene Injection for Urinary Incontinence. The Journal of Urology. 1989;142(3):821-822. doi:10.1016/s0022-5347(17)38903-6

23. Aragona F, D'Urso L, Scremin E, Salmaso R, Glazel GP. Polytetrafluoroethylene Giant Granuloma and Adenopathy: Long-Term Complications Following Subureteral Polytetrafluoroethylene Injection for the Treatment of Vesicoureteral Reflux in Children. The Journal of Urology. 1997;158(4):1539-1542. doi:10.1016/s0022-5347(01)64275-7

24. Boykin W, Rodriguez FR, Brizzolara JP, Thompson IM, Zeidman EJ. Complete Urinary Obstruction Following Periurethral Polytetrafluoroethylene Injection for Urinary Incontinence. The Journal of Urology. 1989;141(5):1199-1200. doi:10.1016/s0022-5347(17)41213-4

25. Ferro MA, Smith JH, Smith PJ. Periurethral Granuloma: Unusual Complication of Teflon Periurethral Injection. Urology. 1988;31(5):422-423. doi:10.1016/0090-4295(88)90740-6

26. Wenig BM, Heffner DK, Oertel YC, Johnson FB. Teflonomas of the Larynx and Neck. Human Pathology. 1990;21(6):617-623. doi:10.1016/s0046-8177(96)90008-8

27. Lakhani R, Fishman JM, Bleach N, Costello D, Birchall M. Alternative Injectable Materials for Vocal Fold Medialisation in Unilateral Vocal Fold Paralysis. Cochrane Database of Systematic Reviews. 2012;10:CD009239. doi:10.1002/14651858.CD009239.pub2

28. Benjamin B, Robb P, Clifford A, Eckstein R. Giant Teflon Granuloma of the Larynx. Head & Neck. 1991;13(5):453-456. doi:10.1002/hed.2880130516

29. Varvares MA, Montgomery WW, Hillman RE. Teflon Granuloma of the Larynx: Etiology, Pathophysiology, and Management. Annals of Otology, Rhinology, and Laryngology. 1995;104(7):511-515. doi:10.1177/000348949510400702

30. Nakayama M, Ford CN, Bless DM. Teflon Vocal Fold Augmentation: Failures and Management in 28 Cases. Otolaryngology Head and Neck Surgery. 1993;109(3 Pt 1):493-498. doi:10.1177/019459989310900318

31. Oberritter Z, Somogyi R, Juhasz Z, Pinter AB. Role of the Teflon Deposit in the Recurrence of Vesicoureteral Reflux. Pediatric Nephrology. 2008;23(5):775-778. doi:10.1007/s00467-007-0725-6

32. Silva LA, Andriolo RB, Atallah ÁN, da Silva EM. Surgery for Stress Urinary Incontinence Due to Presumed Sphincter Deficiency After Prostate Surgery. Cochrane Database of Systematic Reviews. 2014;(9):CD008306. doi:10.1002/14651858.CD008306.pub3