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Historical Bulking Agents

Historical bulking agents are older or experimental urologic injectables that are no longer in routine use. Patients treated with them years ago still present with late effects. Each article separates historical efficacy reports from safety findings and current options.

MaterialMain reason to revisit the history
Teflon (PTFE / Polytef)Persistent particles and foreign-body granulomas: periurethral PTFE migrated to pelvic nodes, lungs and brain in dogs and monkeys,[1] and three children reoperated for recurrent reflux after STING all had PTFE-laden pelvic nodes, with a giant granuloma in one.[5] Injected for incontinence from the 1960s and for reflux (STING) from the 1980s.
Contigen (GAX-collagen)Prior bovine-collagen injections, declining continence benefit and agent-specific reactions. FDA approved in 1993 and withdrawn in 2011.[2]
Autologous FatFailed historical urethral-bulking approach with a fatal embolism in its placebo-controlled trial; distinguish it from cell-based research.[3]
Autologous ChondrocytesExperimental cultured-cartilage implants, their durability and late imaging findings.[4]

Evaluation After Prior Injection​

Presentations to expect include the following.

  • Calcified subureteral mounds (chondrocyte and Deflux implants) that mimic ureterovesical-junction stones on imaging.[4]
  • Persistent or recurrent stress incontinence after periurethral fat injection, which was no more effective than saline in a randomized trial (6/27, 22.2%, versus 6/29, 20.7%, cured or improved at 3 months),[3] or after collagen injection, which left 14 of 53 women (26%) subjectively improved beyond 5 years.[6]
  • PTFE deposits, PTFE-laden pelvic lymph nodes or a late teflonoma after prior PTFE injection.[1][5]

Document the agent, injection site, timing, repeat treatments and subsequent operations when possible. Current symptoms may reflect recurrent incontinence or reflux, obstruction, inflammation, infection, retained material or an unrelated problem.

Assess tissue quality, obstruction, infection and the planned operation; symptomatic masses or fibrosis can alter the approach.

See also: Bulkamid, Macroplastique, Deflux, Incontinence Procedures.

References​

1. Malizia AA Jr, Reiman HM, Myers RP, et al. "Migration and Granulomatous Reaction After Periurethral Injection of Polytef (Teflon)." JAMA. 1984;251(24):3277–3281. doi:10.1001/jama.1984.03340480059030. PMID 6374180

2. US Food and Drug Administration. Contigen Bard Collagen Implant, premarket approval P900030 (approved September 30, 1993; withdrawn October 25, 2011). FDA PMA record

3. Lee PE, Kung RC, Drutz HP. "Periurethral Autologous Fat Injection as Treatment for Female Stress Urinary Incontinence: A Randomized Double-Blind Controlled Trial." J Urol. 2001;165(1):153–158. doi:10.1097/00005392-200101000-00037

4. Gargollo PC, Paltiel HJ, Rosoklija I, Diamond DA. "Mound Calcification After Endoscopic Treatment of Vesicoureteral Reflux With Autologous Chondrocytes: A Normal Variant of Mound Appearance?" J Urol. 2009;181(6):2702–2707. doi:10.1016/j.juro.2009.02.053

5. 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." J Urol. 1997;158(4):1539–1542. doi:10.1016/s0022-5347(01)64275-7

6. Gorton E, Stanton S, Monga A, et al. "Periurethral Collagen Injection: A Long-Term Follow-Up Study." BJU Int. 1999;84(9):966-971. doi:10.1046/j.1464-410x.1999.00321.x