FDA WARNINGS: THE IMPACT ON THE USEOF MESH KITS IN A UNIVERSITY HOSPITAL
H. LIN1, R. K. NG 2;
1Obstetrics and Gynaecology, Natl. Univ. Hosp.,Singapore, Singapore, 2Natl. Univ. Hosp., Singapore,Singapore.
Introduction: Pelvic floordysfunction affects up to 24% of adult women1. Failurerate using native tissue techniques in anterior colporraphy isunacceptably high ranging from 40% to 65.5%2,3,. As aresult, there has been an abundance of innovation amongsturogynaecologists to introduce new techniques and synthetic implantsto improve the current results. The vaginal mesh, which rode on thesuccess of the tension-free transvaginal tape was fashioned to treatan entirely different pathology of prolapse. The approval in clinicaluse was based on minimal clinical trials and testing. It promisedreduced operating time, reduced surgical failures and betteranatomical reconstruction. The exponential propagation was fuelled byearly observational studies, which revealed lower failure rates aftermesh-augmented surgeries as compared to traditional repairtechniques. However the early exuberance was quickly cooled by thecomplications that came such as dyspareunia, mesh erosions. Thisinitiated the U.S FDA to publish safety communications in 2008 and2011 on the efficacy and the complications that vaginal mesh kitsproduce4. Sentiments were further exacerbated by a spateof high profile lawsuits. There is since a significant reduction inpelvic organ prolapse surgeries in which a synthetic mesh wasdeployed5.
Objective: We look at the usage ofvagina mesh kits pre and post FDA warning in a local universityhospital. We hypothesize that the urogynaecologists in our hospitalwill reduce the usage of vagina mesh kits in view of the warning. Wealso aim to look for any trends in the type of vaginal surgeryperformed.
Methods: The second FDA safety warning occuredin 2011. We did a retrospective review of all surgeries for prolapse:uterine, vault, anterior wall and posterior wall prolapse from 1January 2007 to 31 Dec 2016. Surgical codes for vaginal hysterectomywith/without bilateral salpingo-oophorectomy, anterior repair,posterior repair, sacrospinous fixation, abdominal sacrocolpopexy,colpocleisis, mesh repair for pelvic organ prolapse and apical repairfor vault prolapse were extracted using the hospital's operatingtheatre reporting system and cases identified. Data was retrievedfrom the hospital's archived electronic database. Descriptiveanalysis were carried out on Microsoft Excel.
Results: Atotal of 904 cases of pelvic floor prolapse surgery including vaginalhysterectomy with or without salpingo-oophorectomy, with or withoutpelvic floor repair, anterior or posterior repair, colpocleisis,sacrocolpopexy were reviewed. Cases which required sacrospinousfixation or mesh augmentation concurrently or alone were reviewed. Atotal of 88 sacrospinous fixation and 83 mesh kits augmentation wereperformed. The use of meshes grew from 2.8% in 2008 to a peak of28.7% in 2011. Expectedly, the role of the sacrospinous ligamentfixation procedure reduced during the same period from 10% in 2008 toa low of 2% in 2010. After the FDA announcements, the use of meshkits decreased from 5.8% in 2012 to 0% in 2014. There was aninversely proportionate rise in the application of the sacrospinousfixation procedure from 6.3% in 2011 to a high of 22% in 2016. Therewere a brief increase in mesh usage in 2015 (7.3%) and 2016 (4.4%)due to the launch of the Elevate as well as the organisation of aweek long mesh immersion program for urogynaecologists with avisiting expert in the local hospital.
Conclusions: Thisretrospective review reflects the change in surgical practice sincethe FDA safety warnings on the use of vaginal mesh kit in pelvicorgan prolapse surgery. The reduction in number of mesh kits beingdeployed can be attributed to surgical preference, fear oflitigation, patient's influence by media and more importantly theavailability of vaginal mesh kits manufactured. This trend tells usthe increasing need for the gynaecologist operating on pelvic organprolapse to be well trained in native tissue repair including theskill set for sacrocolpopexy and sacrospinous ligamentfixation.
References: 1. Weber LeBrun et al, Pelvic FloorDisorders Registry, Study Design and Outcome Measures. Female PelvicMed Reconstr Surg. 2015 jan 28.
2. Altman D et al. Anteriorcolporrhaphy; a randomised trial of three surgical technbiques. Am JObstet Gynecol 2001;185:1299-304 3. Sand PK, et al. Prospectiverandomised trial of polyglactin 910 mesh to prevent recurrence ofcystocoele and rectoceles. Am J Obstet Gynecol 2001;184:1357-625. 4.Food and Drug Administration (2011) FDA Safety Communication: updateon serious complications associated with transvaginal place- ment ofsurgical mesh for pelvic organ prolapse.5. Clemons JL et al, Impactof the 2011 FDA transvaginal mesh safety update on AUGS members' useof synthetic mesh and biologic grafts in pelvic reconstructivesurgery. Female Pelvic Med Reconstr Surg. 2013 Jul-Aug;19(4):191-8