JAMA Surg. 2022 Jun 1;157(6):542-543. doi: 10.1001/jamasurg.2022.0663.
Patterns in Transvaginal Mesh Surgery After Government Regulation in the United States. Lewicki P(1), Brant A(1), Basourakos SP(1), Qiu Y(2), Chughtai B(1), Shoag JE(1)(3)(4). Author information: (1)Department of Urology, NewYork-Presbyterian Hospital, Weill Cornell Medicine, New York. (2)Department of Healthcare Policy and Research, Weill Cornell Medicine, New York, New York. (3)Department of Urology, University Hospitals Cleveland Medical Center, Cleveland, Ohio. (4)Department of Urology, Case Western Reserve University School of Medicine, Cleveland, Ohio. This case series examines whether the rate of transvaginal mesh repair of pelvic organ prolapse changed after US Food and Drug Administration prohibitions on the sale and distribution of the mesh. DOI: 10.1001/jamasurg.2022.0663 PMCID: PMC9008563 PMID: 35416946 [Indexed for MEDLINE] Conflict of interest statement: Conflict of Interest Disclosures: Dr Shoag reported receiving grants from the Bristol Myers Squibb Foundation and the Damon Runyon Cancer Research Foundation during the conduct of the study and receiving support from the Frederick J. and Theresa Dow Foundation of the New York Community Trust, Vinney Scholars Award, and a Damon Runyon Cancer Research Foundation Physician Scientist Training Award. No other disclosures were reported.
Female Pelvic Med Reconstr Surg. 2022 Mar 1;28(3):160-164. doi:
J Urol. 2021 Jan;205(1):183-190. doi: 10.1097/JU.0000000000001312. Epub 2020 Aug
4. Long-Term Safety with Sling Mesh Implants for Stress Incontinence. Chughtai B(1), Mao J(2), Matheny ME(3)(4), Mauer E(2), Banerjee S(2), Sedrakyan A(2). Author information: (1)Department of Urology, Weill Cornell Medical College-New York Presbyterian, New York, New York. (2)Department of Healthcare Policy and Research, Weill Cornell Medical College-New York Presbyterian, New York, New York. (3)Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee. (4)Geriatric Research Education and Clinical Care (GRECC) Service, Tennessee Valley Healthcare System VA, Nashville, Tennessee. PURPOSE: We examined long-term risks and predictors of mesh erosion and reoperation following mid urethral sling procedure for stress urinary incontinence. MATERIALS AND METHODS: Women aged 18 years or older who received a mid urethral sling for stress urinary incontinence between 2008 and 2016 in outpatient surgical settings in New York State were included in our study. Those who underwent concomitant mesh pelvic organ prolapse repair were excluded. Primary outcomes were post-implantation time to erosion and reoperations. Kaplan-Meier analysis and Cox proportional hazard models were used to assess the risks of erosion diagnosis and reoperation. RESULTS: Our cohort included 36,195 women with a mean±SD age of 53.7±12.4 years. Estimated risks of erosions and reoperations at 7 years after sling procedures were 3.7% and 6.7%, respectively. Older age (≥65 vs <65: HR 0.83, 95% CI 0.70-0.99) and high volume facilities (high vs low: HR 0.79, 95% CI 0.68-0.92) were associated with a lower risk of erosion. History of hysterectomy was associated with a higher risk of erosion (HR 1.62, 95% CI 1.36-1.92). Predictors of reoperation included concurrent abdominal or native tissue transvaginal prolapse repair, previous hysterectomy and depression. CONCLUSIONS: One in 27 women had sling erosions and 1 in 15 had invasive reoperations at 7 years after sling procedures. The highest erosion cases were observed among younger White women treated at low volume facilities. Continued and vigilant surveillance of mesh in stress urinary incontinence repairs, the nature and burden of stress urinary incontinence recurrence, different types of re-treatment, patient reported outcomes and information about treating surgeons are crucial. DOI: 10.1097/JU.0000000000001312 PMID: 32749936 [Indexed for MEDLINE]
Female Pelvic Med Reconstr Surg. 2021 Jan 1;27(1):e133-e138. doi:
Long-term Device Outcomes of Mesh Implants in Pelvic Organ Prolapse Repairs. Chughtai B(1), Mao J, Asfaw TS, Heneghan C, Rardin CR, Sedrakyan A. Author information: (1)Departments of Urology, Healthcare Policy and Research, and Obstetrics and Gynecology, Weill Cornell Medical College-New York Presbyterian, New York, New York; the Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom; and the Division of Urogynecology, the Warren Alpert Medical School of Brown University, and Women & Infants Hospital, Providence, Rhode Island. OBJECTIVE: To evaluate the longer-term safety and reintervention outcomes of mesh implants in pelvic organ prolapse (POP) repairs. METHODS: We conducted a population-based cohort study of women undergoing POP repairs in inpatient and outpatient surgical settings between 2008 and 2016 in New York State. Multivariable logistic regression was used based on patient and procedural characteristics and hospital volume between mesh and nonmesh groups to obtain propensity scores for each individual. Long-term safety events and reinterventions were assessed using time-to-event analysis. RESULTS: We identified 54,194 women undergoing POP repairs (12,989 with mesh, and 41,205 without mesh). Mean age was 59.8 (±13.1) years, and median follow-up was 4.7 years (interquartile range, 2.4-6.8 years). In the propensity score-matched 12,284 pairs of women, POP repair with mesh was associated with a higher risk of reintervention when compared with POP repair without transvaginal mesh (hazard ratio 1.40, 95% CI 1.27-1.54, P<.001). The estimated risk of undergoing a reintervention at 5 years was 8.8% (95% CI 8.2-9.3%) in the mesh group and 6.3% (5.9-6.8%) in the nonmesh group. Among patients who had reinterventions, 18.5% of those operated with mesh had a reintervention related to mesh-related complications. CONCLUSION: Even though transvaginal mesh has been removed from the market, the risk of mesh complications did not diminish over time and these women warrant close follow-up. Continued surveillance of mesh in POP repairs is essential to ensure safety for the women who have already been implanted. DOI: 10.1097/AOG.0000000000003689 PMID: 32028486 [Indexed for MEDLINE]
J Urol. 2017 Oct;198(4):884-889. doi: 10.1016/j.juro.2017.04.099. Epub 2017 May
Int Urogynecol J. 2017 Aug;28(8):1263-1264. doi: 10.1007/s00192-017-3269-8. Epub
2017 Feb 1. The feasibility of transvaginal robotic surgery in the repair of pelvic organ prolapse. Yaghnam I(1), Thomas D(1), Rosenblatt P(2), Chughtai B(3). Author information: (1)Department of Urology, Weill Cornell Medical College/New York Presbyterian, 425 East 61st Street, 12th Floor, New York, NY, 10056, USA. (2)Mount Auburn Hospital, Cambridge, MA, 02138, USA. (3)Department of Urology, Weill Cornell Medical College/New York Presbyterian, 425 East 61st Street, 12th Floor, New York, NY, 10056, USA. bic9008@med.cornell.edu. INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP), the descent of one or more pelvic organs, occurs in an estimated 40 to 60% of parous women. Conventional transvaginal surgery for POP has been plagued with high failure rates. The purpose was to determine the safety and feasibility of robotic transvaginal POP surgery. METHODS: The da Vinci Surgical Robot, SI was used in the POP surgical procedures. There were two cadavers (aged 18 and 78 years of age; BMI 17.2 and 19.2 respectively). POP-Q scores before intervention were stage 1 for both cadavers. RESULTS: The visualization of anatomical landmarks and the placement of sutures at these locations were successful. CONCLUSION: Robotic transvaginal POP is a feasible option for POP surgery. Further studies are warranted to determine the role of robotic transvaginal POP repair. DOI: 10.1007/s00192-017-3269-8 PMID: 28150031 [Indexed for MEDLINE]
Int Urogynecol J. 2017 Aug;28(8):1183-1195. doi: 10.1007/s00192-016-3244-9. Epub
2017 Jan 13. Role of concurrent vaginal hysterectomy in the outcomes of mesh-based vaginal pelvic organ prolapse surgery. Forde JC(1), Chughtai B(2), Anger JT(3), Mao J(4), Sedrakyan A(4). Author information: (1)Beaumont Hospital, Dublin, Ireland, D09 V2N0. (2)Department of Urology, Weill Cornell Medical College/New York Presbyterian Hospital, 425 East 61st Street, 12th Floor, New York, NY, 10065, USA. bic9008@med.cornell.edu. (3)Department of Urologic Reconstruction, Urodynamics, and Female Urology, Department of Surgery, Division of Urology, Cedars-Sinai Medical Center, Los Angeles, CA, USA. (4)Department of Healthcare Policy and Research, Weill Cornell Medical College, New York, NY, USA. INTRODUCTION AND HYPOTHESIS: Hysterectomy is often performed at the time of pelvic organ prolapse (POP) surgery; yet, there is insufficient evidence regarding the specific effect of hysterectomy on outcomes. We sought to determine the outcomes and associated short-term complications of mesh-based POP surgery with and without concurrent hysterectomy. METHODS: We utilized the New York Statewide Planning and Research Cooperation System (SPARCS) database to identify patients under 55 years of age undergoing surgeries for POP with mesh between 2009 and 2014. Patients who had a hysterectomy at the time of mesh-based POP surgery were compared with those who underwent mesh-based POP surgery without hysterectomy. Outcome measures of the patient groups before and after propensity score matching were compared. We assessed the difference Chi-squared tests and log-rank tests in the entire cohort and Mantel-Haenszel stratified Chi-squared tests and Prentice-Wilcoxon tests in the matched cohort. RESULTS: A total of 1,601 women underwent mesh-based POP surgery. 921 patients underwent concurrent hysterectomy, whereas 680 had mesh-based uterine-preserving POP surgery. After propensity score matching, there was no difference in reintervention rates between groups for up to 3 years. Concurrent hysterectomy with mesh-based POP repair was consistently associated with longer hospitalization (20.0% vs 12.8% stayed longer than 2 days) and higher charges (median charges were $22,689 vs $19,273). CONCLUSIONS: Concurrent hysterectomy during mesh-based POP surgery in patients under 55 years led to more expensive charges and a longer stay compared with uterine-preserving mesh surgery. There was no difference in reintervention rates between groups for up to 3 years. DOI: 10.1007/s00192-016-3244-9 PMID: 28091710 [Indexed for MEDLINE]
Am J Obstet Gynecol. 2017 May;216(5):495.e1-495.e7. doi:
JAMA Surg. 2017 Mar 1;152(3):257-263. doi: 10.1001/jamasurg.2016.4200.
Association Between the Amount of Vaginal Mesh Used With Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence. Chughtai B(1), Barber MD(2), Mao J(3), Forde JC(1), Normand ST(4), Sedrakyan A(3). Author information: (1)Department of Urology, Weill Cornell Medical College, New York-Presbyterian Hospital, New York. (2)Obstetrics, Gynecology, and Women’s Health Institute, Cleveland Clinic, Cleveland, Ohio. (3)Department of Healthcare Policy and Research, Weill Cornell Medical College, New York, New York. (4)Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts5Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts. Comment in JAMA Surg. 2017 Mar 1;152(3):263-264. doi: 10.1001/jamasurg.2016.4201. Eur Urol. 2019 Jan;75(1):196-197. doi: 10.1016/j.eururo.2018.10.048. IMPORTANCE: Mesh, a synthetic graft, has been used in pelvic organ prolapse (POP) repair and stress urinary incontinence (SUI) to augment and strengthen weakened tissue. Polypropylene mesh has come under scrutiny by the US Food and Drug Administration. OBJECTIVE: To examine the rates of mesh complications and invasive reintervention after the placement of vaginal mesh for POP repair or SUI surgery. DESIGN, SETTING, AND PARTICIPANTS: This investigation was an observational cohort study at inpatient and ambulatory surgery settings in New York State. Participants were women who underwent transvaginal repair for POP or SUI with mesh between January 1, 2008, and December 31, 2012, and were followed up through December 31, 2013. They were divided into the following 4 groups based on the amount of mesh exposure: transvaginal POP repair surgery with mesh and concurrent sling use (vaginal mesh plus sling group), transvaginal POP repair with mesh and no concurrent sling use (vaginal mesh group), transvaginal POP repair without mesh but concurrent sling use for SUI (POP sling group), and sling for SUI alone (SUI sling group). MAIN OUTCOMES AND MEASURES: The primary outcome was the occurrence of mesh complications and repeated invasive intervention within 1 year after the initial mesh implantation. A time-to-event analysis was performed to examine the occurrence of mesh erosions and subsequent reintervention. Secondary analyses of an age association (<65 vs ≥65 years) were conducted. RESULTS: The study identified 41 604 women who underwent 1 of the 4 procedures. The mean (SD) age of women at their initial mesh implantation was 56.2 (13.0) years. The highest risk of erosions was found in the vaginal mesh plus sling group (2.72%; 95% CI, 2.31%-3.21%) and the lowest in the SUI sling group (1.57%; 95% CI, 1.41%-1.74%). The risk of repeated surgery with concomitant erosion diagnosis was also the highest in the vaginal mesh plus sling group (2.13%; 95% CI, 1.76%-2.56%) and the lowest in the SUI sling group (1.16%; 95% CI, 1.03%-1.31%). CONCLUSIONS AND RELEVANCE: The combined use of POP mesh and SUI mesh sling was associated with the highest erosion and repeated intervention risk, while mesh sling alone had the lowest erosion and repeated intervention risk. There is evidence for a dose-response relationship between the amount of mesh used and subsequent mesh erosions, complications, and invasive repeated intervention. DOI: 10.1001/jamasurg.2016.4200 PMID: 27902825 [Indexed for MEDLINE]
Int Urogynecol J. 2016 Nov;27(11):1761-1766. doi: 10.1007/s00192-016-3040-6.
Epub 2016 May 21. Trends in internet search activity, media coverage, and patient-centered health information after the FDA safety communications on surgical mesh for pelvic organ prolapse. Stone BV(1), Forde JC(1), Levit VB(1), Lee RK(1), Te AE(1), Chughtai B(2). Author information: (1)Department of Urology, Weill Cornell Medical College, New York Presbyterian Hospital, 425 E 61st Street, 12th floor, New York, NY, 10065, USA. (2)Department of Urology, Weill Cornell Medical College, New York Presbyterian Hospital, 425 E 61st Street, 12th floor, New York, NY, 10065, USA. bic9008@med.cornell.edu. INTRODUCTION: In July 2011, the US Food and Drug Administration (FDA) issued a safety communication regarding serious complications associated with surgical mesh for pelvic organ prolapse, prompting increased media and public attention. This study sought to analyze internet search activity and news article volume after this FDA warning and to evaluate the quality of websites providing patient-centered information. METHODS: Google Trends™ was utilized to evaluate search engine trends for the term “pelvic organ prolapse” and associated terms between 1 January 2004 and 31 December 2014. Google News™ was utilized to quantify the number of news articles annually under the term “pelvic organ prolapse.” The search results for the term “pelvic organ prolapse” were assessed for quality using the Health On the Net Foundation (HON) certification. RESULTS: There was a significant increase in search activity from 37.42 in 2010 to 57.75 in 2011, at the time of the FDA communication (p = 0.021). No other annual interval had a statistically significant increase in search activity. The single highest monthly search activity, given the value of 100, was August 2011, immediately following the July 2011 notification, with the next highest value being 98 in July 2011. Linear regression analysis of news articles per year since the FDA communication revealed r2 = 0.88, with a coefficient of 186. Quality assessment demonstrated that 42 % of websites were HON-certified, with .gov sites providing the highest quality information. CONCLUSIONS: Although the 2011 FDA safety communication on surgical mesh was associated with increased public and media attention, the quality of relevant health information on the internet remains of poor quality. Future quality assurance measures may be critical in enabling patients to play active roles in their own healthcare. DOI: 10.1007/s00192-016-3040-6 PMID: 27209310 [Indexed for MEDLINE]
Regulatory Warnings and Use of Surgical Mesh in Pelvic Organ Prolapse. Sedrakyan A(1), Chughtai B(2), Mao J(1). Author information: (1)Department of Healthcare Policy and Research, Weill Medical College of Cornell University, New York, New York. (2)Department of Urology, Weill Medical College of Cornell University, New York-Presbyterian Hospital, New York. Comment in JAMA Intern Med. 2016 Feb;176(2):277-8. doi: 10.1001/jamainternmed.2015.7155. DOI: 10.1001/jamainternmed.2015.6595 PMID: 26713426 [Indexed for MEDLINE]
Sep 4. Trends in Mesh Use for Pelvic Organ Prolapse Repair From the Medicare Database. Wang LC(1), Al Hussein Al Awamlh B(1), Hu JC(1), Laudano MA(1), Davison WL(1), Schulster ML(1), Zhao F(2), Chughtai B(1), Lee RK(3). Author information: (1)Department of Urology, Weill Medical College of Cornell University, New York, NY. (2)Department of Urology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China. (3)Department of Urology, Weill Medical College of Cornell University, New York,
Electronic address: ril9010@med.cornell.edu.
Comment in J Urol. 2017 Feb;197(2):481-482. doi: 10.1016/j.juro.2016.11.012. OBJECTIVE: To investigate recent trends in mesh use for pelvic organ prolapse (POP)-related reconstruction procedures. MATERIALS AND METHODS: Using the 2001-2011 5% Medicare claims database, we identified POP diagnoses and related procedures. Transvaginal mesh use and sacrocolpopexy were first reported in 2005 and 2004, respectively. RESULTS: A total of 613,160 cases of vaginal and abdominal POP repair procedures were identified. The majority of procedures involved multiple compartments. The rate of mesh use increased dramatically from 2% of repairs in 2005 to 35% by
After the Food and Drug Administration warning in 2008, mesh use plateaued
Diagnosis, Evaluation, and Treatment of Mixed Urinary Incontinence in Women. Chughtai B(1), Laor L(1), Dunphy C(1), Lee R(1), Te A(1), Kaplan S(1). Author information: (1)Department of Urology, Weill Cornell Medical College, New York, NY. Mixed urinary incontinence (MUI) is a common clinical problem in the community and hospital setting. The broad definition of the term makes it difficult to diagnose, as well as determine effective treatment strategies. There are no current guidelines recommended for physicians. The estimated prevalence of this condition is approximately 30% in all women with incontinence. It has also been suggested that patients with MUI report more bothersome symptoms than either stress or urge incontinence; approximately 32% of 40- to 64-year-olds with MUI report symptoms of depression. The authors examine the diagnosis, evaluation, and treatment of patients with MUI. DOI: 10.3909/riu0653 PMCID: PMC4857898 PMID: 27222643
Can J Urol. 2014 Oct;21(5):7460-4.
Urodynamic characterization of lower urinary tract symptoms in women less than 40 years of age. Jamzadeh AE(1), Xie D, Laudano MA, Elterman DS, Seklehner S, Shtromvaser L, Lee R, Kaplan SA, Te AE, Tyagi R, Chughtai B. Author information: (1)Weill Cornell Medical College of Cornell University, New York, New York, USA. INTRODUCTION: Lower urinary tract symptoms (LUTS) in young women is becoming a more recognized urologic issue that can arise from many causes, each with their own management strategy. The purpose of this study was to determine the rates of various etiologies for LUTS in women under 40 years of age. MATERIALS AND METHODS: Video urodynamic studies (VUDS) were performed in 70 women age 40 years or less with LUTS for greater than 6 months between March 2005 and June 2012 at Weill Cornell Medical College. Patients with culture-proven bacterial urinary tract infections, pelvic organ prolapse greater than grade I, symptoms for less than 6 months, a history of neurologic disease, or previous urological surgery affecting voiding function, were excluded from the analysis. RESULTS: The mean age of the patients was 31.95 ± 5.57. There were 48 patients that presented with more than one urinary symptom (68.57%). The most frequent complaints included: urinary frequency (n = 42, 34.15%), incontinence (n = 26, 21.14%), and urinary urgency (n = 22, 17.89%). The most common urodynamic abnormality was dysfunctional voiding (n = 25, 28.74%), detrusor overactivity (n = 15, 20.00%), bladder outlet obstruction (n = 8, 11.43%). There were no significant differences seen in complaints or AUA symptom and quality of life scores across diagnosis groups. CONCLUSIONS: Persistent LUTS can present in younger women with an unclear etiology, which may be characterized using VUDS. The most common etiology found is dysfunctional voiding followed by detrusor overactivity. This study shows that the etiology can be more accurately determined using VUDs, which can assist in management. PMID: 25347371 [Indexed for MEDLINE]
J Urol. 2014 Apr;191(4):1022-7. doi: 10.1016/j.juro.2013.10.076. Epub 2013 Oct
22. Ambulatory pessary trial unmasks occult stress urinary incontinence. Chughtai B(1), Spettel S, Kurman J, De E. Author information: (1)Continence Center, Urological Institute of Northeast New York and Division of Urology, Albany Medical College, Albany, NY 12208, USA. Objective. We evaluated the use of a one-week ambulatory pessary trial in predicting patients’ postoperative outcomes for occult stress incontinence. Methods. Patients with anterior vaginal wall prolapse were offered a pessary trial to predict response to reconstruction. We performed a retrospective review of 4 years of cases. All patients underwent a detailed evaluation including videourodynamics with and without pessary reduction. Results. Twenty-six patients completed the 1-week pessary trial. Ten (38%) women showing no evidence of stress urinary incontinence (SUI) underwent surgical repair of prolapse without anti-incontinence procedure. None of these patients had SUI postoperatively. Sixteen women (61%) had occult stress urinary incontinence on evaluation and underwent concurrent sling procedure. Three (19%) of these patients were identified by the pessary trial alone. Twenty-five of the 26 patients were without clinical stress incontinence at a mean follow up of 12 months (range 4-37 months). The pessary trial correctly predicted persistent urgency in six patients and persistent frequency in five. No patients with SUI or persistent voiding difficult were missed in a pessary trial. Conclusion. An ambulatory pessary trial is an effective, easy, and inexpensive method to approximate anatomic results achieved by surgery under real-life conditions. In our series, 20% of patients with occult SUI were identified by pessary trial alone. DOI: 10.1155/2012/392027 PMCID: PMC3178112 PMID: 21949665