What a mesh! An Australian experience using national female continence surgery trends over 20 years.

PURPOSE: To review the evolution of female continence surgical practice in Australia over the last 20 years and observe whether vaginal mesh controversies impacted these trends. MATERIALS AND METHODS: From January 2000 to December 2019, medicare benefit schedule codes for female continence procedures were identified and extracted for: mesh sling, fascial sling, bulking agent, female urethral prosthesis, colposuspension, and removal of sling. Population-adjusted incidences per 100,000 persons were calculated using publicly available demographic data. Three discrete phases were defined over the study time frame for analysis: 2000-2006; 2006-2017, and 2017-2019. Interrupted time-series analyses were conducted to assess for impact on incidence at 2006 and 2017. RESULTS: There were 119,832 continence procedures performed in Australia from 2000 to 2019, with the mid-urethral sling (MUS) the most common (72%). The majority of mesh (n = 63,668, 73%) and fascial sling (n = 1864, 70%) procedures were in women aged < 65 years. Rates of mesh-related procedures steeply declined after 2017 (initial change: -21 cases per 100,000; subsequent rate change: -12 per 100,000, p < 0.001). Non-mesh related/bulking agents increased from + 0.34 during 2006-2017 to + 2.1 per 100,000 after 2017 (p < 0.001). No significant change in mesh extraction was observed over 2006-2017 (+ 0.06 per 100,000, p = 0.192). There was a significant increase in mesh extraction procedures after 2017 (0.83 per 100,000, p < 0.001). CONCLUSION: Worldwide, controversy surrounding vaginal mesh had a significant impact on Australian continence surgery trends. The most standout trends were observed after the 2017 Australian class-action lawsuit and Senate Inquiry.

[Trends in the use of midurethral slings after the new legislation: A nationwide survey]. / Évolution des pratiques après l'arrêté encadrant les bandelettes sous-urétrales : résultats d'une enquête nationale.

INTRODUCTION: The French Department of Health published on October 23, 2020 a decree governing acts associated with mid-urethral sling (MUS) operations. The aim of this study was to evaluate the changes in practice following this new legislation. METHODS: A cross-sectional study was carried out among French urologists and gynecologists using an online survey to collect changes in practices since the publication of the decree. RESULTS: From January to February 2021, 436 surgeons participated in the survey. Among these surgeons, 87% were aware of the new legislation and 56% of them considered the decree as useless. The order resulted in an increase in working time in 81% of cases. Among these surgeons, 66% of the surgeons worked in tertiary referral centers for the management of incontinence, of which 55% had a multidisciplinary meeting in urogynecology. Among the surgeons, 31% considered this meeting to be useful but 80% considered that it did not lead to any change in surgical indications, even though 33% of complications of BSU were discussed there. In conclusion, 61% of surgeons felt more reluctant to schedule a BSU placement with this new legislation. CONCLUSION: The majority of questioned surgeons considered the decree as useless. It generated few changes in practices which already respected the law on information, consultation, consent, experience and training. Most urologists and gynecologists are more reluctant to offer MUS after this new legislation. LEVEL OF EVIDENCE: 4.

Temporal Trends of Urogynecologic Mesh Reports to the U.S. Food and Drug Administration.

OBJECTIVE: To compare temporal trends of urogynecologic mesh medical device reports with sentinel U.S. Food and Drug Administration (FDA) notices and to examine all linked reports of patient death. METHODS: The Reed Tech Navigator is an online tool used to extract and analyze data in the Manufacturer and User Facility Device Experience database. We used FDA product codes to search for reports of synthetic mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Reports with "death" listed as a patient event were queried further. RESULTS: There were 43,970 medical device reports involving urogynecologic mesh reported to the FDA between August 2000 and January 2019, with most occurring after the 2011 FDA communication (n=43,018, 97.8%). Of these medical device reports, 64.6% (n=28,422) were for SUI products, 27.0% (n=11,876) were for transvaginal POP products, and 8.4% (n=3,672) were for transabdominal POP products. Peak reporting occurred in 2013, which corresponded with the first major plaintiff verdicts and class action vaginal mesh settlement. There were 645 (1.5%) medical device reports of death, with 49.3% (n=318) having no cause of death identified. Only four (0.6%) could be directly attributed to the initial surgery. CONCLUSION: Since 2011, urogynecologic mesh has been the focus of thousands of medical device reports annually, although the data submitted are often incomplete. Few reported deaths are directly attributable to mesh products, and the majority lack sufficient information to draw causal conclusions. A high-quality registry is necessary to improve our understanding of the patient effect from urogynecologic mesh products.

Recent trends in the management of pelvic organ prolapse in Australia and New Zealand.

OBJECTIVE: To compare current practice in the management of female pelvic organ prolapse in Australia and New Zealand with that in 2007, and assess the impact on practice of the withdrawal of Prolift® and Prosima® mesh kits in 2015. MATERIALS AND METHODS: In early 2015, two invitations to participate in a survey, including a link to Surveymonkey, were emailed to 2506 Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) trainees and fellows. The online survey closely resembled a printed survey that was posted to RANZCOG trainees and fellows in 2007 and had additional questions relating to the impact of withdrawal of Prolift® and Prosima® products. RESULTS: Four-hundred-and-three doctors participated, giving a response rate of 16%. Native tissue repair was the procedure of choice for primary and recurrent prolapse of the anterior and posterior vaginal wall. An implant was used to treat 45% of anterior recurrences and 25% of posterior recurrences. Vaginal hysterectomy and repair were the procedures of choice for uterovaginal prolapse. Sacrospinous hysteropexy was the uterine preservation procedure of choice, preferred by 41%. For post-hysterectomy vault prolapse, sacrospinous colpopexy and vaginal repair was preferred by 65% of respondents. Between 2007 and 2015, there was a substantial decrease in respondents' usage of implants across all indications except for midurethral slings and sacrocolpo/hysteropexy. Forty-two percent of respondents changed their practice as a result of Prolift® and Prosima® being withdrawn. CONCLUSION: There is a trend toward increasing use of various native tissue prolapse repair procedures and midurethral slings, and less utilisation of transvaginal mesh for prolapse.

Results of the British Association of Urological Surgeons female stress urinary incontinence procedures outcomes audit 2014-2017.

OBJECTIVES: To analyse the results of the stress urinary incontinence (SUI) audit conducted by the British Association of Urological Surgeons (BAUS), and to present UK urologists' contemporary management of SUI. PATIENTS AND METHODS: The BAUS audit tool is an online resource, to which all UK urologists performing procedures for SUI are invited to submit data. The data entries for procedures performed during 2014-2016 were collated and analysed. RESULTS: Over the 3-year period analysed, 2917 procedures were reported by 109 surgeons, with a median of 20 procedures reported per surgeon. A total of 2 366 procedures (81.1%) were recorded as a primary surgery, with 548 procedures (18.8%) performed for recurrent SUI. Within the time period analysed, changes were noted in the frequency of all procedures performed, with a trend towards a reduction in the use of synthetic mid-urethral tapes, and a commensurate increase in the use of urethral bulking agents and autologous fascial slings. A total of 107 (3.9% of patients) peri-operative complications were recorded, with no association identified with patient age, BMI or surgeon volume. Follow-up data were available on 1832 patients (62.8%) at a median of 100 days postoperatively. Reduced pad use was reported in 1311 of patients (84.5%) with follow-up data available and 86.3% reported a pad use of one or less per day. In all, 375 patients (85%) reported being satisfied or very satisfied with the outcome of their procedure at follow-up, although data entry for this domain was poor. De novo overactive bladder (OAB) symptoms were reported by 15.2% of patients (263/1727), and this was the most commonly reported postoperative complication. For those reporting pre-existing OAB prior to their SUI surgery, 28.7% (307/1069) of patients reported they got better after their procedure, whilst 61.9% (662/1069) of patients reported no change and 9.4% of patients (100/1 069) got worse. CONCLUSIONS: This review identified that, despite urological surgeons undertaking a relatively low volume of procedures per year, SUI surgery by UK urologists is associated with excellent short-term surgeon- and patient-reported outcomes and low numbers of low grade complications. Complications do not appear to be associated with surgeon volume, nor do they appear higher in those undergoing mesh surgery. Shortfalls in data collection have been identified, and a longer follow-up period is required to comment adequately on long-term complications, such as chronic pain and tape extrusion/erosion rates.

Changing surgical trends for female stress urinary incontinence in England.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) surgery has significantly evolved with the introduction of synthetic midurethral slings (MUS). However, following reports from the US Food and Drug Administration and European Commission, the use of vaginal meshes in urogynaecology has been largely scrutinised. We analysed trends in female SUI surgery in England from 2000 to 2017. METHODS: The Hospital Episode Statistics database was retrieved from the Health and Social Care Information Centre website. Specific four-character codes of the evolving OPCS-4 coding system were used to quantify SUI operations. RESULTS: We analysed 180,773 admissions from 2000 to 2017. A steep rise in MUS use was noted until 2008-2009, followed by a consistent drop, with a nadir of 6383 procedures in 2016-2017. Removal of MUS has become increasingly popular, with a peak of 591 in 2012-2013. Numbers for traditional continence operations remained low. Colposuspensions markedly decreased to 189 in 2012-2013, with a slight positive trend only in the last few years, while autologous sling use costantly dropped from 262 to 124 throughout the study period. Admissions for urethral bulking agents increased from 650 to 1324 in the last 2 years. CONCLUSIONS: MUS represents the most commonly performed procedure for SUI, despite an obvious reduction in the last 8 years. Urethral bulking agents are becoming more popular, while the numbers of colposuspensions and autologous slings are still low. Training programmes should take into account current shifts in surgical practice.

AdVance sling use decreasing relative to artificial urinary sphincters.

INTRODUCTION: To evaluate the percent of AdVance male sling usage relative to artificial urinary sphincters (AUS) over a 9 year period since its introduction in order to assess trends across the United States. MATERIALS AND METHODS: As a surrogate for procedures performed, we reviewed device utilization trends of the AdVance sling and AUS broken down by American Urological Association (AUA) section. ANOVA testing between years was used to determine purchasing trends with p values of < 0.05 considered statistically significant. RESULTS: Relative to AUS, AdVance sling percentage significantly increased from 36% in 2007 to 48% in 2008 (p = 0.032). Sling percentage then remained stable over the next 3 years from 2008-2011 with no significant percent change between years (p = NS). Compared with 2008-2011, AdVance usage decreased in 2012 to 29% (p = 0.002) and remained stable at this decreased relative level through 2015 (p = NS, difference between years 2012-2015). Comparing incontinence procedures across AUA sections, the Southeast section performed the highest percentage of male stress urinary incontinence procedures, including 27% of all AdVance slings and 25% of all artificial sphincters. CONCLUSION: Proportion of AdVance sling usage relative to AUS increased after its introduction through 2008. Usage remained stable at an increased level for the next3 years. More recent years have found decreased AdVance usage and a resurgence of the artificial urinary sphincter. Reasons for these trends remain speculative.

Waves of Change: National Trends in Surgical Management of Male Stress Incontinence.

OBJECTIVE: To determine the trend in surgical management of male stress urinary incontinence (SUI) in the context of the rate of radical prostatectomy (RP) as reported by a national database. Traditionally, the artificial urinary sphincter (AUS) has been the gold standard, but the male sling represents a newer and popular alternative. Refinements in prostate surgery may reduce the incidence and degree of subsequent SUI. MATERIALS AND METHODS: A retrospective cross-sectional analysis was performed using the National Inpatient Survey database, which captures discharge data from inpatient and overnight admissions. Cases were identified by their International Classification of Diseases, Ninth Revision procedure codes. We queried the codes 58.93 (implantation of AUS), 59.4 (suprapubic sling operation), 59.5 (retropubic urethral suspension), and 59.6 (paraurethral suspension). We also queried 60.5 (RP) for comparison. Data were collected from January 2000 to December 2012 and weighted to a national average using National Inpatient Survey guidelines. RESULTS: A total of 32,416 anti-incontinence operations (20,790 AUS and 11,625 sling procedures) were performed over the study period. There was a significant downward trend in the total number of incontinence procedures (F(1,11) = 6.15, P = .03). However, when stratifying the data by procedure type, only AUS placement demonstrated a significant decline (F(1,11) = 21.70, P <.01), whereas sling procedures significantly increased (F(1,11) = 12.95, P <.01). There was no significant change in the annual incidence of RP. CONCLUSION: Inpatient surgery for male SUI is decreasing overall. Placement of the AUS declined significantly, whereas sling placement became more common. Future study will determine the etiology of these trends.

Stress urinary incontinence surgery trends in academic female pelvic medicine and reconstructive surgery urology practice in the setting of the food and drug administration public health notifications.

AIMS: To investigate the possible effects of the Food and Drug Administration (FDA) Public Health Notifications in 2008 and 2011 regarding surgical trends in transvaginal mesh (TVM) placement for stress urinary incontinence (SUI) and related mesh revision surgery in Female Pelvic Medicine & Reconstructive Surgery (FPMRS) practice in tertiary care academic medical centers in the United States. METHODS: Surgical volume for procedures performed primarily by FPMRS surgeons at eight academic institutions across the US was collected using Current Procedural Terminology (CPT) codes for stress urinary incontinence repair and revision surgeries from 2007 to 2013. SAS statistical software was used to assess for trends in the data. RESULTS: There was a decrease in the use of synthetic mesh sling for the treatment of SUI at academic tertiary care centers over the past 7 years; however, this was not statistically significant. While the total number of surgical interventions for SUI remained stable, there was an increase in the utilization of autologous fascia pubovaginal slings (AFPVS). The number of mesh sling revision surgeries, including urethrolysis and removal or revision of slings, increased almost three-fold at these centers. CONCLUSIONS: These observed trends suggest a possible effect of the FDA Public Health Notifications regarding TVM on surgical practice for SUI in academic centers, even though they did not specifically warn against the use of synthetic mesh for this indication. Indications for surgery, complications, and outcomes were not evaluated during this retrospective study. However, such data may provide alternative insights into reasons for the observed trends. Neurourol. Urodynam. 36:1155-1160, 2017. © 2016 Wiley Periodicals, Inc.

Age-stratified trends in 20 years of stress incontinence surgery in Australia.

BACKGROUND: Stress urinary incontinence (SUI) is a common, debilitating condition in Australian women. Since its introduction in 1998-1999, the less invasive mid-urethral sling (MUS) procedure has become the new standard for surgical correction of SUI and overall numbers of continence procedures increased. Trends since 2009 have not been analysed. AIMS: To identify patterns in the surgical treatment of women with SUI in Australia from January 1994 to December 2014 stratified by age. MATERIALS AND METHODS: Gender- and age-specific data from Medicare Australia between January 1994 and December 2014 were extracted and the patterns of SUI surgery analysed for the 20-year period. Data on gynaecologists and urologists performing MUS and colposuspension were collected from Department of Human Services. RESULTS: Following the introduction of MUS, total SUI operations increased with the peak in 2002, a plateau between 2006 and 2011, and a new decline from 2012 onwards. There has been a sustained 51.7% increase in total SUI operations in 75- to 84-year-old women, and a 105.2% increase in women aged over 84. However, SUI operations in 45- to 64-year-olds decreased below pre-MUS baseline in 2014. CONCLUSIONS: Mid-urethral sling has become the standard SUI procedure being performed in Australia since its introduction in 1999. SUI operations have increased each year for patients aged over 65, with the greatest increase seen in patients aged over 84 - indicating expanded eligibility for SUI surgery in older women. However, since 2010, there has been a fall in SUI operations to below the pre-MUS baseline.

What is new in the use of mesh in vaginal surgery? Best articles from the past year.

This month we focus on current research in use of mesh in vaginal surgery. Dr. Fischer discusses four recent publications, and each is concluded with a "bottom line" that is the take-home message. The complete reference for each can be found in Box 1 on this page, along with direct links to the abstracts.

Slings for urinary incontinence and the application of cell-based therapy.

The most commonly used technique for the treatment of stress urinary incontinence (SUI) in women is the suburethral polypropylene sling, using either a retropubic or transobturator tape approach This treatment results in a cure rate of over 80%, based on both subjective and objective evaluations. Biological slings have been largely abandoned due to lack of efficacy. Despite the high success rates, 10-20% of women remain incontinent. Cell-based therapy might offer solutions for the future both for the primary setting as for the treatment of failures. Preclinical studies suggest that stem cells (SC) can enhance the recovery of damaged tissue either by direct integration and replacement of damaged tissue (differentiation) or by secreting factors that influence host response mechanisms (paracrine effect). The clinical data to date do not allow strong efficacy conclusions, except that SC therapy seems to be safe in the short term. Most published studies use autologous cells. Allogeneic cell sources need to be investigated as well to allow ready-to-use solutions in the future. Most importantly, we need better insight into the mechanisms of action. We need more basic stem cell research, better acute and chronic animal models, better investigational tools and more efforts using tissue engineering approach.

Trends in reoperation for female stress urinary incontinence: A nationwide study.

AIMS: Using the National Health Insurance (NHI) database in Taiwan, the study aimed to evaluate the rates and associated factors for reoperation of female stress incontinence. METHODS: Records of female patients who had received a primary surgical treatment for stress incontinence from January 2000 to December 2006 were retrieved. Among these, patients who had reoperations during follow-up till December 2010 were identified. The data were analyzed for reoperation rates, surgery methods, patient demography, surgeon, and hospital attributes. RESULTS: Among 14,613 patients with a mean follow-up of 86.28 ± 26.76 months, 563 (3.85%) had reoperations, an incidence rate of 54.37 per 10,000 person year (PY). Injection procedures had the highest reoperation rate of 893.30/10,000 PY. The adjusted hazard ratio (HR) of reoperation was higher for mid-urethral sling when compared to pubovaginal sling (HR 1.54, 95% CI 1.16-2.05) or retropubic urethropexy including Burch operation (HR 1.30, 95% CI 1.04-1.61). Surgeons with high service volumes tended to have fewer reoperations. No correlations were noted between the reoperation rate with patient age, surgeon age/gender, year of operation and hospital status. However, urologists had higher reoperation rates than gynecologists. For repeat surgery, the majority of patients chose the same specialty but different surgical types. Mid-urethral sling was used most commonly in 48.85% of reoperations. CONCLUSIONS: Substantial number of patients need reoperation for stress incontinence. The choice of primary surgery type and surgeon specialty may affect the reoperation rates. Mid-urethral sling is the most common reoperation choice.

Managing urinary incontinence: what works?

Urinary incontinence is a common condition, which, although not life-threatening, impairs the health-related quality of life of affected individuals. All women complaining of incontinence require a basic assessment and those with complex or refractory symptoms may benefit from urodynamic studies. Initial treatment includes lifestyle advice, behavioral modifications, bladder retraining and pelvic floor muscle training. For those women with persistent stress urinary incontinence following conservative therapy, surgical management might be considered. The development of the minimally invasive, retropubic, synthetic, mid-urethral sling procedures has revolutionized stress incontinence surgery and reduced the popularity of 'traditional' procedures, such as colposuspension and autologous fascial sling. In an attempt to reduce further the morbidity, transobturator and single-incision slings have been introduced. While antimuscarinic agents are the mainstay of the current medical management of urgency urinary incontinence, a recently developed selective ß3-adrenergic receptor agonist (mirabegron) offers an alternative pharmacological option. Modalities such as intravesical botulinum toxin and neuromodulation (peripheral or sacral) are available to women with refractory urgency incontinence. Finally, when all other options have been explored and proven unsuccessful, inappropriate or not feasible, reconstructive surgery or catheter insertion might be considered as a last resort. The aim of this paper is to review conservative, medical and surgical management for urinary incontinence by using the best available evidence in the literature.

The surgical trends and time-frame comparison of primary surgery for stress urinary incontinence, 2006-2010 vs 1997-2005: a population-based nation-wide follow-up descriptive study.

INTRODUCTION AND HYPOTHESIS: The purpose of our study was to describe the surgical trends for female stress urinary incontinence (SUI) during 2006-2010, and a time-frame comparison with 1997-2005, based upon the National Health Insurance (NHI) claims data in Taiwan. METHODS: Women who underwent various primary surgeries for SUI during 2006-2010 were identified, with a total of 15,099 inpatients. The variables included surgical types, patient age, surgeon age and gender, specialty, and hospital accreditation levels. Chi-squared tests and SAS version 9.3.1 were used for statistical analysis. RESULTS: During the follow-up study, midurethral sling (MUS) application increased significantly from 53.09 % in 2006 to 78.74 % in 2010. It was associated concomitantly with a decrease in retropubic urethropexy (RPU) from 29.68 % to 12.99 %, and pubovaginal sling treatment (PVS) from 9.33 % to 3.46 %. MUS was most commonly used among all patients' and surgeons' age groups, and different accreditation hospital levels. MUS was more commonly used by gynecologists (71.38 %) than urologists (57.91 %); while PVS and periurethral injection were more commonly performed by urologists than gynecologists. Similar surgical trends were found during time-frame comparison, 2006-2010 vs 1997-2005. SUI surgeries increased in patients aged ≥60, surgeons aged ≥ 50, and in regional hospitals. CONCLUSION: This follow-up study depicts the increase in popularity of MUS and offers evidence of surgical trends and a paradigm shift for female SUI surgery. More older women were willing to seek healthcare and undergo surgery. The surgical skills and knowledge spread from medical centers into regional hospitals. The time-frame shift may have a profound impact on patients, as well as the healthcare providers.

Recent developments in technology for the assessment and management of incontinence.

Urinary incontinence, the leakage of urine, is a common condition, which can have a significant impact on a patient's quality-of-life. Incontinence may arise as a consequence of a weakness of the urinary sphincter or bladder dysfunction, usually over-activity. Incontinence therapies occupy a large proportion of the healthcare budget. As no single device to manage incontinence is appropriate for all situations, a diverse range of products are available on the market and the development of improved products based on fundamental designs has been slow. This review highlights some of the key issues of continence care and describes the current technology and recent developments involved in the diagnosis, assessment and treatment of incontinence, along with the strengths and limitations of these methods. These issues are imperative to address if improved technology is to be developed.

Midurethral sling is the dominant procedure for female stress urinary incontinence: analysis of case logs from certifying American Urologists.

OBJECTIVE: To investigate contemporary trends in the use of midurethral sling procedures for the surgical correction of female stress urinary incontinence over the past decade. METHODS: Annualized case log data for female incontinence surgeries from certifying and recertifying urologists were obtained from the American Board of Urology. Descriptive analysis of the number and type of cases per year was performed. Associations between surgeon characteristics and the use of female incontinence procedures were evaluated. RESULTS: A total of 6355 nonpediatric urologists applied for certification or recertification between 2003 and 2012. Two-thirds (4185) reported performing any procedures for female incontinence. Procedures sharply increased from 4632 in 2003 to 7548 in 2004, then remained relatively stable between 2005 and 2012 (range, 8014-10,238 cases). Traditional procedures decreased from 17% of female incontinence procedures in 2003 to 5% in 2004 to <1% since 2010 (P <.0005). Midurethral sling procedures have risen sharply from 3210 procedures in 2003 to 7200 in 2012 (P <.0005). Endoscopic injection treatments have remained stable. CONCLUSION: Midurethral slings have been widely adopted by urologists over the last decade. Increase in sling usage coincided with a drastic decline in traditional repairs, implying that the newer midurethral slings were replacing these traditional procedures for the treatment of female incontinence. In addition, the fact that the use of periurethral injections did not change significantly during this time period indicates that increased sling usage is responsible for most of the decline in traditional repairs.

Changing trends in surgery for stress urinary incontinence.

PURPOSE OF REVIEW: Currently, a number of different stress urinary incontinence (SUI) procedures exist. The relatively recent adoption of the midurethral sling into clinical practice has changed the surgical management of SUI. This critical evaluation of the trends in SUI surgery emphasizes the public health burden of SUI surgery, provides insight into modern clinical practice, determines whether these trends reflect evidence-based data, and highlights potential areas for future research. RECENT FINDINGS: Trends in SUI surgery have shown a rise in the use of midurethral mesh slings with a concomitant decrease in retropubic procedures. The rates of other types of SUI surgery remain quite low. Although the overall rate of slings has increased dramatically, limited population-based data exist regarding specific types of midurethral slings, such as retropubic vs. transobturator vs. mini-slings. There is a need for continued evaluation of these trends in response to heightened public awareness of the potential risks of synthetic mesh. SUMMARY: The midurethral sling has become the gold standard surgery for SUI. It will be important to evaluate future trends in SUI surgery given the dynamic changes in new techniques for midurethral slings and long-term evidence regarding the effectiveness and risks of specific sling types.

Mesh sling in an era of uncertainty: lessons learned and the way forward.

Following transvaginal mesh, synthetic slings to correct stress urinary incontinence have been put under further scrutiny. Since the recent FDA website update, we reviewed the latest developments and then reflected on the lessons learned by applying this process and the way forward.