PMID- 37774851
OWN - NLM
STAT- MEDLINE
DCOM- 20240103
LR  - 20240423
IS  - 1527-9995 (Electronic)
IS  - 0090-4295 (Linking)
VI  - 183
DP  - 2024 Jan
TI  - Real-World Complications of the SpaceOAR Hydrogel Spacer: A Review of the 
      Manufacturer and User Facility Device Experience Database.
PG  - 157-162
LID - S0090-4295(23)00835-X [pii]
LID - 10.1016/j.urology.2023.09.016 [doi]
AB  - OBJECTIVE: To characterize adverse events related to use of the perirectal 
      spacing agent SpaceOAR, we examined the Manufacturer and User Facility Device 
      Experience (MAUDE) database. METHODS: The MAUDE database was queried for 
      "SpaceOAR" and "Augmenix" from June 2015 (when SpaceOAR was approved by the Food 
      and Drug Administration) to October 2022. Reports were reviewed for adverse 
      events (AEs), operative procedures performed because of the AE, and changes to 
      the radiation plan. AEs were categorized using Common Terminology Criteria for 
      Adverse Events (CTCAE), version 5.0. RESULTS: Six hundred fifty-four reports were 
      reviewed. Eighty-four were excluded and 4 reports reviewed 2 separate cases of 
      SpaceOAR administration. Five hundred seventy-four cases were ultimately 
      included. Three deaths were reported (0.5% of all AEs). One point six percent of 
      cases represented CTCAE grade 4 injuries (life-threatening consequences; urgent 
      intervention indicated), 15.9% grade 3 (severe but not immediately 
      life-threatening; hospitalization), 24.2% grade 2 (moderate; local/noninvasive 
      intervention), and 57% of events were CTCAE grade 1 (mild; asymptomatic or mild 
      symptoms). Bowel diversion occurred in 29 cases (9%). CONCLUSION: Both 
      asymptomatic (n = 311) and debilitating (n = 12) complications of SpaceOAR 
      hydrogel use were identified. Death, gel embolization, anaphylaxis, rectal 
      ulcerations, and infections requiring bowel or urinary diversions were among the 
      complications reviewed. Providers should consider these potential complications 
      before perirectal spacer administration and during patient counseling.
CI  - Copyright (c) 2023 Elsevier Inc. All rights reserved.
FAU - Fernandez, Adrian M
AU  - Fernandez AM
AD  - Department of Urology, University of California San Francisco, San Francisco, CA. 
      Electronic address: Adrian.Fernandez@ucsf.edu.
FAU - Jones, Charles P
AU  - Jones CP
AD  - Department of Urology, University of California San Francisco, San Francisco, CA.
FAU - Patel, Hiren V
AU  - Patel HV
AD  - Department of Urology, University of California San Francisco, San Francisco, CA.
FAU - Ghaffar, Umar
AU  - Ghaffar U
AD  - Department of Urology, University of California San Francisco, San Francisco, CA.
FAU - Hakam, Nizar
AU  - Hakam N
AD  - Department of Urology, University of California San Francisco, San Francisco, CA.
FAU - Li, Kevin D
AU  - Li KD
AD  - Department of Urology, University of California San Francisco, San Francisco, CA.
FAU - Nabavizadeh, Behnam
AU  - Nabavizadeh B
AD  - Department of Urology, University of California San Francisco, San Francisco, CA.
FAU - Breyer, Benjamin N
AU  - Breyer BN
AD  - Department of Urology, University of California San Francisco, San Francisco, CA; 
      Department of Epidemiology and Biostatistics, University of California San 
      Francisco, San Francisco, CA. Electronic address: Benjamin.Breyer@ucsf.edu.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20230927
PL  - United States
TA  - Urology
JT  - Urology
JID - 0366151
RN  - 0 (Hydrogels)
SB  - IM
MH  - Humans
MH  - United States/epidemiology
MH  - *Hydrogels/adverse effects
MH  - *Intestines
MH  - Databases, Factual
MH  - United States Food and Drug Administration
COIS- Declaration of Competing Interest Benjamin N. Breyer receives Fellowship funding 
      from Boston Scientific Corporation. The other authors declare no conflict of 
      interest.
EDAT- 2023/09/30 09:42
MHDA- 2024/01/03 09:42
CRDT- 2023/09/29 19:14
PHST- 2023/07/18 00:00 [received]
PHST- 2023/08/29 00:00 [revised]
PHST- 2023/09/19 00:00 [accepted]
PHST- 2024/01/03 09:42 [medline]
PHST- 2023/09/30 09:42 [pubmed]
PHST- 2023/09/29 19:14 [entrez]
AID - S0090-4295(23)00835-X [pii]
AID - 10.1016/j.urology.2023.09.016 [doi]
PST - ppublish
SO  - Urology. 2024 Jan;183:157-162. doi: 10.1016/j.urology.2023.09.016. Epub 2023 Sep 
      27.