Investig Clin Urol.  2018 Mar;59(2):126-132. 10.4111/icu.2018.59.2.126.

An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh

• Sandberg J
• Gray I
• Pearlman A
• Terlecki R

• KMID: 2404982
• DOI: http://doi.org/10.4111/icu.2018.59.2.126

Abstract

PURPOSE
To assess the utility of the Manufacturer And User Facility Device Experience (MAUDE) database in objectively capturing adverse events for transvaginal mesh in the United States.
MATERIALS AND METHODS
We reviewed 1,103 individual medical device reports submitted to the MAUDE database that inspired the United States (US) Food and Drug Administration's 2008 Public Health Notification. Entries were compiled into a categorical database that reported manufacturer, brand, reporter type, report source, and type of adverse event.
RESULTS
There were numerous examples of missing, duplicated, and non-standardized entries. Analysis revealed 64 reports with duplicated information, and six reports representing multiple patients. Forty-seven percent of medical device reports did not identify a reporter source. At least 28% of reported devices are no longer on the US market. There was wide variability in the quality and completeness of submitted reports and true adverse event rates could not be accurately calculated because the number of total cases was unknown.
CONCLUSIONS
The MAUDE database was limited in its ability to collect, quantify, and standardize real-life adverse events related to transvaginal mesh. While it functions to collect information related to isolated adverse events, systematic limitations of the MAUDE database, that no doubt extend to other medical devices, necessitate the development of new reporting systems. Alternatives are under development, which may allow regulators to more accurately scrutinize the safety profiles of specific medical devices.

Keyword

Equipment safety; Registries; Surgical mesh; United States Food and Drug Administration

MeSH Terms

Equipment Safety
Humans
Public Health
Registries
Surgical Mesh
United States Food and Drug Administration
United States*

Reference

1. Administration TFaD. MAUDE-manufacturer and user facility device experience [Internet]. Silver Spring: U.S. Food and Drug Administration;2014. updated 2014 Mar 31. cited 2014 Apr 4. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/textsearch.cfm.

2. Administration TFaD. FDA public health notification: serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. Silver Spring: U.S. Food and Drug Administration;2008.

3. Administration TFaD. FDA safety communication: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Silver Spring: U.S. Food and Drug Administration;2011.

4. Murphy M, Holzberg A, van Raalte H, Kohli N, Goldman HB, Lucente V. Pelvic Surgeons Network. Time to rethink: an evidence-based response from pelvic surgeons to the FDA safety communication: “UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse”. Int Urogynecol J. 2012; 23:5–9. PMID: 22086260.

5. FDA. FDA issues proposal to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse. Med Device Online. 2014; 4. 29. [Epub].

6. Administration TFaD. Urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. Atlanta: Childers, Schlueter & Smith, LLC;2011.

7. Elterman DS, Chughtai BI, Vertosick E, Maschino A, Eastham JA, Sandhu JS. Changes in pelvic organ prolapse surgery in the last decade among United States urologists. J Urol. 2014; 191:1022–1027. PMID: 24513165.

8. Obstetrics & Gynecology Device Advisory Committee Meeting. Surgical Mesh for Treatment of Women with Pelvic Organ Prolapse and Stress Urinary Incontinence: FDA Executive Summary [Internet]. Silver Spring: U.S. Food and Drug Administration;2011. updated 2011 Sep 9. cited 2014 Apr 4. Available from: https://goo.gl/7G6RZa.

9. Yoshimura K, Kadoyama K, Sakaeda T, Sugino Y, Ogawa O, Okuno Y. A survey of the FAERS database concerning the adverse event profiles of α1-adrenoreceptor blockers for lower urinary tract symptoms. Int J Med Sci. 2013; 10:864–869. PMID: 23781132.

10. Poluzzi E, Raschi E, Koci A, Moretti U, Spina E, Behr ER, et al. Antipsychotics and torsadogenic risk: signals emerging from the US FDA Adverse Event Reporting System database. Drug Saf. 2013; 36:467–479. PMID: 23553446.

11. Edwards BJ, Bunta AD, Lane J, Odvina C, Rao DS, Raisch DW, et al. Bisphosphonates and nonhealing femoral fractures: analysis of the FDA Adverse Event Reporting System (FAERS) and international safety efforts: a systematic review from the Research on Adverse Drug Events And Reports (RADAR) project. J Bone Joint Surg Am. 2013; 95:297–307. PMID: 23426763.

12. Chotikawanich E, Korman E, Monga M. Complications of stone baskets: 14-year review of the manufacturer and user facility device experience database. J Urol. 2011; 185:179–183. PMID: 21074791.

13. Harth KC, Rosen MJ. Major complications associated with xenograft biologic mesh implantation in abdominal wall reconstruction. Surg Innov. 2009; 16:324–329. PMID: 20031943.

14. Sakaeda T, Tamon A, Kadoyama K, Okuno Y. Data mining of the public version of the FDA Adverse Event Reporting System. Int J Med Sci. 2013; 10:796–803. PMID: 23794943.

15. Anderson-Smits C. Developing of the Pelvic Floor Disorder Registry (PFDR). Silver Spring: U.S. Food and Drug Administration;2012.

16. Bradley CS, Visco AG, Weber LeBrun EE, Barber MD. The pelvic floor disorders registry: purpose and development. Female Pelvic Med Reconstr Surg. 2016; 22:77–82. PMID: 26829344.