Use Of Transvaginal Mesh Research Articles

MP10-19 TRENDS AND FAILURE RATES IN THE MEDICAL TREATMENT OF PELVIC ORGAN PROLAPSE FOR MEDICARE PATIENTS

INTRODUCTION AND OBJECTIVES: The efficacy of transvaginal mesh for anterior colporrhaphy is well established (Nguyen 2008); however, complications related to use of transvaginal mesh led to the release of FDA safety communications in 2008 and 2011. This led to a significant decrease in the use of transvaginal mesh for pelvic organ prolapse (POP) since 2011 (Clemens 2013). We hypothesized that the decrease in transvaginal mesh use was partly driven by increased patient awareness of complications. We tested this using Google Trends , a public tool that provides data on temporal patterns of search terms and correlated this data with the timing of the FDA communications. METHODS: Weekly relative search volume (RSV) was obtained from Google Trends using the search term 00transvaginal mesh00, with higher RSV indicating an increase in search volume. These were divided into three groups: 2005 to July 13th 2011 (the date of the second FDA communication), a six-month period following the update, and thereafter until June 6th 2015. The distribution of the weekly RSV over the three periods was tested using one-way analysis of variance. We also tested the difference between total number of web pages containing 00transvaginal mesh00 (reported annually by Google) between 2006-2010 versus 2011-2015 using a paired t-test. RESULTS: The mean RSV prior to the 2011 FDA communication was 0.73 [standard deviation (SD)1⁄46.6], compared to 29.9 (SD1⁄417.0) in the six months after the update and 18.8 (SD1⁄47.7) thereafter (p<0.001), with no increase in RSV seen with the 2008 safety communication. The mean number of web pages on Google containing 00transvaginal mesh00 between 2006-2010 was 2,484 (SD1⁄41,388) vs. 38,680 (SD1⁄412,859) between 2011-2015 (p<0.001); the largest increase in search terms was seen between 2010 (4,390 webpages) to 2011 (25,500 webpages), reflecting the effect of the 2011 update. CONCLUSIONS: The FDA communication regarding transvaginal mesh for POP in 2011 was associated with significant increases in both Google search activity and total number of webpages about transvaginal mesh. This suggests the rise in lawsuits and decreased use of transvaginal mesh for POP may be partially driven by increased patient awareness of complications.

MP10-18 GOOGLE TRENDS©: A MEASURE OF THE SOCIETAL IMPACT OF THE FDA TRANSVAGINAL MESH SAFETY COMMUNICATIONS

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Pelvic Prolapse1 Apr 2016MP10-18 GOOGLE TRENDS©: A MEASURE OF THE SOCIETAL IMPACT OF THE FDA TRANSVAGINAL MESH SAFETY COMMUNICATIONS Juzar Jamnagerwalla, Brent Medoff, Karyn S. Eilber, and Jennifer T. Anger Juzar JamnagerwallaJuzar Jamnagerwalla More articles by this author , Brent MedoffBrent Medoff More articles by this author , Karyn S. EilberKaryn S. Eilber More articles by this author , and Jennifer T. AngerJennifer T. Anger More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.2348AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The efficacy of transvaginal mesh for anterior colporrhaphy is well established (Nguyen 2008); however, complications related to use of transvaginal mesh led to the release of FDA safety communications in 2008 and 2011. This led to a significant decrease in the use of transvaginal mesh for pelvic organ prolapse (POP) since 2011 (Clemens 2013). We hypothesized that the decrease in transvaginal mesh use was partly driven by increased patient awareness of complications. We tested this using Google Trends©, a public tool that provides data on temporal patterns of search terms and correlated this data with the timing of the FDA communications. METHODS Weekly relative search volume (RSV) was obtained from Google Trends© using the search term ″transvaginal mesh″, with higher RSV indicating an increase in search volume. These were divided into three groups: 2005 to July 13th 2011 (the date of the second FDA communication), a six-month period following the update, and thereafter until June 6th 2015. The distribution of the weekly RSV over the three periods was tested using one-way analysis of variance. We also tested the difference between total number of web pages containing ″transvaginal mesh″ (reported annually by Google) between 2006-2010 versus 2011-2015 using a paired t-test. RESULTS The mean RSV prior to the 2011 FDA communication was 0.73 [standard deviation (SD)=6.6], compared to 29.9 (SD=17.0) in the six months after the update and 18.8 (SD=7.7) thereafter (p<0.001), with no increase in RSV seen with the 2008 safety communication. The mean number of web pages on Google containing ″transvaginal mesh″ between 2006-2010 was 2,484 (SD=1,388) vs. 38,680 (SD=12,859) between 2011-2015 (p<0.001); the largest increase in search terms was seen between 2010 (4,390 webpages) to 2011 (25,500 webpages), reflecting the effect of the 2011 update. CONCLUSIONS The FDA communication regarding transvaginal mesh for POP in 2011 was associated with significant increases in both Google search activity and total number of webpages about transvaginal mesh. This suggests the rise in lawsuits and decreased use of transvaginal mesh for POP may be partially driven by increased patient awareness of complications. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e109 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Juzar Jamnagerwalla More articles by this author Brent Medoff More articles by this author Karyn S. Eilber More articles by this author Jennifer T. Anger More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

An Update on the Use of Mesh in Pelvic Reconstructive Surgery

By 2008, the use of vaginal mesh in gynecologic surgery was at its peak. Unfortunately, the rise in transvaginal mesh use was accompanied by a significant rise in mesh-related complications. Over the last 5 years, the FDA has been very proactive in regulating the use of transvaginal mesh, and its use has declined substantially since FDA sanctions were placed. Mesh for the treatment of stress urinary incontinence and transabdominal repair of pelvic organ prolapse is still supported by the FDA as well as the gynecologic and urologic societies. Surgeons should exercise caution when using any type of surgical mesh for the treatment of pelvic floor disorders, and its use should remain in the hands of experienced pelvic floor surgeons in patients who meet strict criteria and are well informed about its potential risks and benefits.

Seeking new surgical predictors of mesh exposure after transvaginal mesh repair.

The purpose of this study was to explore new preventable risk factors for mesh exposure. A retrospective review of 92 consecutive patients treated with transvaginal mesh (TVM) in the urogynecological unit of our university hospital. An analysis of perioperative predictors was conducted in patients after vaginal repairs using a type 1 mesh. Mesh complications were recorded according to International Urogynecological Association (IUGA) definitions. Mesh-exposure-free durations were calculated by using the Kaplan-Meier method and compared between different closure techniques using log-rank test. Hazard ratios (HR) of predictors for mesh exposure were estimated by univariate and multivariate analyses using Cox proportional hazards regression models. The median surveillance interval was 24.1months. Two late occurrences were found beyond 1year post operation. No statistically significant correlation was observed between mesh exposure and concomitant hysterectomy. Exposure risks were significantly higher in patients with interrupted whole-layer closure in univariate analysis. In the multivariate analysis, hematoma [HR 5.42, 95% confidence interval (CI) 1.26-23.35, P = 0.024), Prolift mesh (HR 5.52, 95% CI 1.15-26.53, P = 0.033), and interrupted whole-layer closure (HR 7.02, 95% CI 1.62-30.53, P = 0.009) were the strongest predictors of mesh exposure. Findings indicate the risks of mesh exposure and reoperation may be prevented by avoiding hematoma, large amount of mesh, or interrupted whole-layer closure in TVM surgeries. If these risk factors are prevented, hysterectomy may not be a relative contraindication for TVM use. We also provide evidence regarding mesh exposure and the necessity for more than 1year of follow-up and preoperative counselling.

Vaginal Mesh in Pelvic Reconstructive Surgery: Controversies, Current Use, and Complications.

In 2001, the Food and Drug Administration approved the first surgical mesh product specifically designed for the surgical repair of pelvic organ prolapse and between 2004 and 2008, the use of vaginal mesh in gynecologic surgery was at its peak. Unfortunately, the rise in transvaginal mesh use was accompanied by a surge of adverse events and mesh-related complications. As a result, the Food and Drug Administration put forth several efforts to regulate the manufacturing of vaginal mesh products. These notifications have been supported by several gynecologic societies, and recommendations now exist not only on the placement of mesh and patient selection, but also on the evaluation and management of mesh-related complications. In addition, data on outcomes following management of these complications are now emerging.

Trends in Mesh Use for Pelvic Organ Prolapse Repair From the Medicare Database

To investigate recent trends in mesh use for pelvic organ prolapse (POP)-related reconstruction procedures. 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. 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 2008. After the Food and Drug Administration warning in 2008, mesh use plateaued and then decreased in 2011. Mesh was used more commonly in younger (odds ratio [OR] 0.722, P < .001), white (OR 0.712-0.791 for other races, P < .001) women in the South (OR 0.741-0.848 for non-South regions, P < .001). Starting in 2008, the rate of sacrocolpopexy procedures almost doubled yearly until 2011. Sacrocolpopexy was more common in younger patients (49% in women <70 years) and in white women (88%); the majority of sacrocolpopexies were performed in the South (60%) and laparoscopically (83%-98%). The treatment of POP has changed over time. The use of mesh increased significantly until 2008, after which it plateaued following the Food and Drug Administration warning regarding mesh-related complications. Concurrently, the number of sacrocolpopexy procedures increased significantly starting in 2008 as the use of laparoscopic and/or robotic technique and concern regarding transvaginal mesh increased.

Female pelvic medicine and reconstructive surgery practice patterns: IUGA member survey.

The purpose of this study is to describe the current practice patterns of the International Urogynecological Association (IUGA) members regarding the diagnosis, evaluation, and surgical management of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). A 30-item internet-based survey was sent to IUGA members. Response to the survey was voluntary, and subjects answered questions regarding demographics, the evaluation of POP and SUI, including urodynamics (UDS) testing, preferred management of POP and SUI, and the application of mesh in reconstructive surgery. Three hundred and thirty-four IUGA members responded to the survey; most of the responses were from Europe (40 %) and North America (23 %). After the FDA safety communication regarding serious complications of using transvaginal mesh, 45 % of responders reported decreased use of mesh, while 31 % reported that it had no effect or that they did not use mesh for transvaginal prolapse (23.6 %). Regarding the evaluation and treatment of SUI, 51 % of responders would perform urodynamics (UDS) before surgical correction of uncomplicated SUI and 78.5 % of responders would perform UDS if no urine leakage was demonstrated on examination. The preferred method of treatment for SUI is midurethral sling (MUS), regardless of prior treatments (65.1 %), concomitant surgeries (74.5 %), or examination findings (50.8-92.6 %). Regarding POP repair, the preferred approach for apical (61 %) and posterior (99.4 %) prolapse repair is vaginal. Most respondents use a vaginal approach for POP surgery. The FDA safety communication regarding serious complications related to the use of transvaginal mesh for prolapse surgery led to a global decrease in the employment of mesh for POP. Synthetic midurethral slings are predominant in the current treatment of SUI. Despite new recommendations, many responders still perform UDS for uncomplicated SUI.

Management of apical pelvic organ prolapse.

Pelvic organ prolapse is a prevalent condition, with up to 12 % of women requiring surgery in their lifetime. This manuscript reviews the treatment options for apical prolapse, specifically. Both conservative and surgical management options are acceptable and should be based on patient preferences. Pessaries are the most commonly used conservative management options. Guided pelvic floor muscle training is more beneficial than self-taught Kegel exercises, though may not be effective for high stage or apical prolapse. Surgical treatment options include abdominal and vaginal approaches, the latter of which can be performed open, laparoscopically, and robotically. A systematic review has demonstrated that sacrocolpopexy has better long-term success for treatment of apical prolapse than vaginal techniques, but vaginal surgery can be considered an acceptable alternative. Recent data has demonstrated equal efficacy between uterosacral ligament suspension and sacrospinous ligament suspension at 1 year. To date, two randomized controlled trials have demonstrated equal efficacy between robotic and laparoscopic sacrocolpopexy. Though abdominal approaches may have increased long-term durability, when counseling their patients, surgeons should consider longer operating times and increased pain and cost with these procedures compared to vaginal surgery. • Pelvic floor physical therapy (PFPT) with a physical therapist is the best approach to conservative management of apical prolapse [10]. • Pessaries should be managed with regular follow-up care to minimize complications [14•]. • Minimally invasive sacrocolpopexy appears as effective as the gold standard abdominal sacrocolpopexy (ASC) [42•]. • Robotic assisted sacrocolpopexy (RASC) and laparoscopic assisted sacrocolpopexy (LASC) are equally effective and should be utilized by pelvic floor surgeons based on their skill level and expertise in laparoscopy [44, 45•]. • Uterosacral ligament suspension (USLS) and sacrospinous ligament suspension (SSLS) are considered equally effective procedures and can be combined with a vaginal hysterectomy. • Obliterative procedures are effective but are considered definitive surgery [24••]. • The use of transvaginal mesh has been shown in some studies to be superior to native tissue repairs with regard to anatomic outcomes, but complication rates are higher. Transvaginal mesh should be reserved for surgeons with adequate training so that complications are minimized.

The Role of Mid-urethral Slings in 2014: Analysis of the Impact of Litigation on Practice

Over 90,000 legal claims for complications related to transvaginal mesh have been filed to date. Safety issues specifically related to the use of transvaginal mesh for pelvic organ prolapse have not been appropriately differentiated from the use of mesh for stress urinary incontinence by either attorneys or the media. This litigious environment and nebulous communication on the safety issues have led to patient and physician concern regarding mesh slings for the treatment of stress urinary incontinence. The ultimate result is likely to be a decrease in use of the gold standard of care for stress urinary incontinence—the mid-urethral synthetic sling.

Current role of mesh in vaginal prolapse surgery.

This report summarizes the latest literature on transvaginal mesh (TVM) for the treatment of pelvic organ prolapse, with a focus on indications for use and management of complications. We describe trends in TVM by reviewing the recent literature and summarizing national meeting presentations. Vaginal mesh complications are most often managed surgically, and the majority of patients experiencing mesh-related pain have symptom improvement after intervention. New efforts will focus on identifying variables associated with success after intervention for mesh-related complications, to aid reconstructive pelvic surgeons in outcome prediction and patient counselling. Although the use of TVM has plateaued in recent years, we are seeing an exponential rise in synthetic mesh implant removal. Reconstructive pelvic surgeons advising patients with TVM complications should report that surgical intervention is often necessary, improvement rates of pain-related symptoms after surgery are high, and up to a third may require multiple interventions.

Long-Term Follow-up of Treatment for Synthetic Mesh Complications

Transvaginal synthetic mesh products were introduced more than 10 years ago to improve success rates of traditional pelvic organ prolapse and stress urinary incontinence repair methods. However, limited data are available showing symptomatic benefits of transvaginal mesh use. Moreover, with increased use of vaginal mesh, there has been increasing incidence of mesh complications, including vaginal mesh exposure and contraction. Although several treatments of mesh complications have been investigated, it is unclear whether these treatments alleviate their symptoms, especially long-term. This retrospective study had 2 aims. The first was to describe the presenting symptoms, findings, and treatment of complications resulting from placement of synthetic vaginal mesh. The second was to describe the self-reported improvement and function at least 6 months after treatment of complications. Women presenting with mesh complications at a single urogynecology center between 2006 and 2011 were identified by diagnostic codes. Data were abstracted from a chart review of medical records; the women were asked to complete a follow-up questionnaire consisting of several validated survey instruments. One hundred eleven women met criteria for inclusion and were evaluated for complications associated with synthetic mesh. The mean interval from the placement of mesh to presentation for evaluation of symptoms was 2.4 years. Of the 111 women, 93 (84%) were referred from outside hospitals. Mesh complications occurred with the following index surgeries: vaginal mesh kits/vaginally placed mesh (47%), midurethral mesh slings (38%), abdominally placed vaginal mesh (11%), and vaginal mesh kit with concomitantly placed mesh sling (4.5%). The most common complications reported were mesh extrusion (65%), mesh contraction (17%), chronic pelvic pain (16%), and obstructive voiding (9%). Ninety-eight women (88%) underwent multidisciplinary treatment by urogynecologists, pelvic pain specialists, or physical therapists; 85 (87%) of these underwent mesh excision. Follow-up data were provided by 84 (76%) of the patients at a mean interval since management of the complication of 2.3 years. At follow-up, the mean (SD) Pelvic Floor Distress Inventory and EuroQol-5 Dimension questionnaire index scores were 98 (67) and 0.69 (0.23), respectively. Vaginal discharge was reported by 22% of the women; 15% had vaginal bleeding or spotting, and 45% sexually inactive women were abstinent because of mesh-related problems. At follow-up, 71% of the women reported being overall better than their status when presenting with the mesh complication, whereas 29% were the same or worse. These data show that, 2 years after multidisciplinary treatment of vaginal mesh complications, symptoms are still reported that negatively impact quality of life. Mesh complications are difficult to treat successfully. Most patients require surgical intervention.

Patient Perception of Transvaginal Mesh and the Media

To assess the penetration of media-based information on transvaginal mesh (TVM) in our patient population and to determine whether exposure affects patient opinion. Since the 2011 Federal Drug Administration communication on TVM, many advertisements from legal practices have been directed toward patients. An 18-item survey was administered to female patients at 2 sites from August 2012 to April 2013. Patients presenting with new diagnoses of pelvic organ prolapse or stress urinary incontinence or patients who reported prior mesh surgery were excluded. Ninety-nine questionnaires were completed. Sixty-six of the patients (67%) were aware of TVM; and of these, 38 (58%) cited advertisements as the initial source of information. Only 12% were aware of the Food and Drug Administration's communication. Regarding opinion of TVM, 9% chose "it is a safe product," 9% "safety depends on factors related to patient," 4.5% "not a safe product," 1.5% "safety depends on the doctor," 68% "I don't know," and 4.5% marked 2 selections. Only 12% indicated knowing the difference in the use of TVM for pelvic organ prolapse vs stress urinary incontinence. When asked what influenced their opinion of TVM the most; responses were as follows: advertisement (33.3%), medical professional (22.7%), friends or family who underwent TVM procedure (12.1%), media article (6.1%), and "not sure" (25.8%). Advertisements of TVM lawsuits had a high penetration into our patient population but did not produce an overtly negative response in our sample. Clinicians should be aware of the impact of these advertisements on patient opinion and counsel patients accordingly with unbiased and scientifically accurate information.

The use of mesh implants in vaginal prolapse surgery: Position statement and recommendations of the South African Urogynaecology Association

This is the 2014 updated guideline and position statement from the South African Urogynaecology Association on the use of transvaginal mesh for the surgical correction of pelvic organ prolapse.

Implications of the FDA Statement on Transvaginal Placement of Mesh: The Aftermath

The release of the U.S. Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh (TVM) for pelvic organ prolapse (POP) has resulted in changes in the pelvic reconstruction community. This monograph reviews the implications of the FDA statements over the last 18-24 months. Recent findings show that there have been significant developments in the areas of regulatory mandates, media and medico-legal activity, and statements from surgical societies. In summary, well-publicized communications from the FDA and major medical organizations are defining a change in the use of TVM for POP.

Anterior vaginal compartment surgery

To review the safety and efficacy of anterior vaginal compartment pelvic organ prolapse surgery. Every 4 years and as part of the Fifth International Collaboration on Incontinence we reviewed the English-language scientific literature after searching PubMed, Medline, Cochrane library and the Cochrane database of systematic reviews, published up to January 2012. Publications were classified as level 1 evidence (randomised controlled trials [RCT] or systematic reviews), level 2 (poor quality RCT, prospective cohort studies), level 3 (case series or retrospective studies) and level 4 case reports. The highest level of evidence was utilised by the committee to make evidence-based recommendations based upon the Oxford grading system. A grade A recommendation usually depends on consistent level 1 evidence. A grade B recommendation usually depends on consistent level 2 and/or 3 studies, or "majority evidence" from RCTs. A grade C recommendation usually depends on level studies or "majority evidence" from level 2/3 studies or Delphi processed expert opinion. A grade D "no recommendation possible" would be used where the evidence is inadequate or conflicting and when expert opinion is delivered without a formal analytical process, such as by Delphi. Absorbable mesh augmentation of anterior compartment native tissue repair improves the anatomical outcome compared with native tissue repair alone with no increased complication rate in meta-analysis of 2 RCTS (grade B). Biological grafts in meta-analysis have improved anatomical outcomes with no change in subjective outcomes compared with native tissue repairs (grade B). There is conflicting level 1 evidence to support porcine dermis and a single RCT to support small intestine submucosa as graft agents in anterior compartment prolapse surgery (grade B). Consistent level 1 data support a superior anatomical outcome for polypropylene mesh compared with a biological graft in the anterior compartment. Mesh exposure rate was significantly higher in the polypropylene mesh group (grade A). Consistent level 1 evidence demonstrates superior subjective and objective outcomes following anterior transvaginal polypropylene mesh as compared to anterior colporrhaphy (grade A). These outcomes did not translate into improved functional results using validated questionnaires or a lower reoperation rate for prolapse. The mesh group was also associated with longer operating time, greater blood loss and apical or posterior compartment prolapse as compared with anterior repair. Anterior polypropylene mesh had a mesh extrusion rate of 10.4% with 6.3% requiring a surgical correction (grade B). Single level 3 evidence does not support the use of transvaginal polypropylene mesh for recurrent anterior vaginal wall prolapse (grade C). Polypropylene anterior compartment mesh offers improved objective and subjective outcomes compared with native tissue repair; however, these benefits must be considered in the context of increased morbidity associated with anterior polypropylene transvaginal mesh.

Impact of the 2011 FDA Transvaginal Mesh Safety Update on AUGS Members’ Use of Synthetic Mesh and Biologic Grafts in Pelvic Reconstructive Surgery

To describe the frequency of use and recent change in use of synthetic mesh and biologic grafts in pelvic organ prolapse (POP) and stress urinary incontinence surgery by American Urogynecology Society (AUGS) members. An electronic survey of AUGS members was conducted between December 2011 and January 2012. Frequency of graft use in POP (overall and by transvaginal and transabdominal approaches) and stress urinary incontinence surgery was queried relative to the timing of the 2011 Food and Drug Administration (FDA) safety update. Rates of materials' use before and after the statement were compared using Wilcoxon signed rank test. Fifty-three percent (507/962) of AUGS members responded and were included in analysis; 79% were urogynecologists. Before the FDA warning, in POP surgery, most (90%) used synthetic mesh and fewer (34%) used biologic grafts; 99% used synthetic mesh slings. After the FDA statement, respondents reported an overall decrease in the percent of POP cases in which they used synthetic mesh (P < 0.001) but no change in biologic graft use for POP (P = 0.37) or synthetic mesh sling use (P = 0.10). Specifically, transvaginal mesh use decreased: 40% reported decreased use and 12% stopped use. However, transvaginal mesh was still used by 61% of respondents in at least some cases. No change (62%) or increased use (12%) of mesh was reported for transabdominal POP procedures. Synthetic mesh use in transvaginal POP surgery decreased after the 2011 FDA safety update, but synthetic mesh use for transabdominal POP repair and sling procedures and overall biologic graft use in POP surgery did not decrease.

Indications, Contraindications, and Complications of Mesh in Surgical Treatment of Pelvic Organ Prolapse

Women are seeking care for pelvic organ prolapse in increasing numbers and a significant proportion of them will undergo a second repair for recurrence. This has initiated interest by both surgeons and industry to utilize and design prosthetic mesh materials to help augment longevity of prolapse repairs. Unfortunately, the introduction of transvaginal synthetic mesh kits for use in women was done without the benefit of level 1 data to determine its utility compared with native tissue repair. This report summarizes the potential benefit/risks of transvaginal synthetic mesh use for pelvic organ prolapse and recommendations regarding its continued use.

2150 PUBLIC PERCEPTION OF VAGINAL MESH AND THE MEDIA

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Pelvic Prolapse1 Apr 20132150 PUBLIC PERCEPTION OF VAGINAL MESH AND THE MEDIA Jennifer Chamberlain, Taylor Vaughn, J.Christian Winters, Eric S. Rovner, Melissa R. Kaufman, and Michelle Koski Jennifer ChamberlainJennifer Chamberlain New Orleans, LA More articles by this author , Taylor VaughnTaylor Vaughn Charleston, SC More articles by this author , J.Christian WintersJ.Christian Winters New Orleans, LA More articles by this author , Eric S. RovnerEric S. Rovner Charleston, SC More articles by this author , Melissa R. KaufmanMelissa R. Kaufman Nashville, TN More articles by this author , and Michelle KoskiMichelle Koski Charleston, SC More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2059AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Since the 2011 FDA communication on transvaginal mesh (TVM), there has been a rapid increase in lawsuit advertisements in various media directly marketed to patients. We have encountered patients with heightened concerns citing these ads. Through a questionnaire-based study we hoped to assess the penetrance of ads into our patient population and to assess whether exposure to these ads affects patient opinion. METHODS A 17 item multiple choice survey was designed and beginning 8/2012, was given to female patients in urology and urogynecology clinics at two academic institutions after IRB approval. New patients with pelvic organ prolapse (POP) or stress incontinence (SUI) and patients who had undergone prior surgery at our institutions were excluded. We continue to accrue patients. RESULTS 78 questionnaires were completed. 53 (66.7%) of the patients had heard of TVM and of these, 33 (62%) cited such ads as the initial source of information. Regarding opinion of TVM, 1.9% chose “it is a safe product,” 7.5% “safety depends on factors related to patient,” 1.9% “not a safe product,” and 77.4% “I don't know.” 5.7% chose 2 selections and 3.8% patients chose “safety depends on the doctor”. Of those aware of TVM, 9 would consider mesh if they needed surgery for POP, 11 “no,” and 30 “maybe.” Of the “no” or “maybe” respondents- if a doctor told them they would benefit from mesh, 30.2% would change their mind, 9.4% would not, and 39.6% might. Only 11.3% indicated knowing the difference in use of TVM for POP vs. SUI. 15.1% were aware of the FDA safety communication. When asked what was the strongest influence on their opinion of TVM, responses were: advertisement, newspaper, or internet (32.1%), medical professional (26.4%), and “not sure” (28.3%). CONCLUSIONS Advertisements of TVM lawsuits have a high penetrance into our patient population. Few patients knew of the FDA communication or the difference in indication for TVM between POP and SUI. Despite this, patients indicated that they would still consider TVM, especially if advised by a physician. We must be aware of the effect of these ads on patient opinion and provide effective, unbiased, and scientifically accurate counseling of risks and benefits. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e880-e881 Peer Review Report Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jennifer Chamberlain New Orleans, LA More articles by this author Taylor Vaughn Charleston, SC More articles by this author J.Christian Winters New Orleans, LA More articles by this author Eric S. Rovner Charleston, SC More articles by this author Melissa R. Kaufman Nashville, TN More articles by this author Michelle Koski Charleston, SC More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

The Role of Vaginal Mesh Procedures in Pelvic Organ Prolapse Surgery in View of Complication Risk

Synthetic transvaginal mesh has been employed in the treatment of pelvic organ prolapse for more than a decade. As the use of these devices increased during this period so did adverse event reporting. In 2008, the Food and Drug Administration (FDA) Public Health Notification informed physicians and patients of rising concerns with the use of synthetic transvaginal mesh. Shortly thereafter and in parallel to marked increases in adverse event reporting within the Manufacturer and User Device Experience (MAUDE), the FDA released a Safety Communication regarding urogynecologic surgical mesh use. Following this report and in the wake of increased medical industry product withdrawal, growing medicolegal concerns, patient safety, and clinical practice controversy, many gynecologists and pelvic reconstructive surgeons are left with limited long-term data, clinical guidance, and growing uncertainty regarding the role of synthetic transvaginal mesh use in pelvic organ prolapse. This paper reviews the reported complications of synthetic transvaginal mesh with an evidence-based approach as well as providing suggested guidance for the future role of its use amidst the controversy.

Pearls and Pitfalls of Mesh Surgery

This article attempts to offer balanced insight into the use of transvaginal mesh for pelvic organ prolapse especially in the light of the negative publicity in recent times. The role of transvaginal mesh has been in the limelight for a number of reasons and it is important to address this issue in an objective, fair, and balanced manner. The conventional approach to prolapse surgery has undergone a paradigm shift and the principles of mesh replacement surgery sharply contrast with many traditionally held beliefs. This has created a new set of challenges that has revealed a sharp division of opinion among specialists and sub-specialists alike. The article is an attempt to explain how mesh surgery can be safely and efficiently performed in carefully selected cases and is based on the combined wisdom of some of the leading surgeons in the sub-specialty today.