The French Cochlear Implant Registry (EPIIC): General indicators.

Cochlear and brainstem implants have been included on the list of reimbursable products (LPPR) in France since March of 2009. The implants were initially inscribed for 5 years, after which an application for renewal with the French National Commission for the Evaluation of Medical Devices and Health Technologies (Commission Nationale d'évaluation des dispositifs médicaux et des technologies de santé - CNEDiMTS) was required [Haute Autorité de santé, 2009]. Upon registration to the list of reimbursable products, the companies and the reference centers for cochlear and brainstem implants were asked to set up a post-registration registry called EPIIC. This article reports the evolution in the EPIIC registry of the general indicators for 5051 patients over the five years from 2012-2016.

Free-of-charge long-acting reversible contraception: two-year discontinuation, its risk factors, and reasons.

BACKGROUND: Since 2013, the residents of the city of Vantaa, Finland, have been offered their first long-acting reversible contraceptive method (levonorgestrel-releasing intrauterine system, implant, and copper intrauterine device) free of charge. OBJECTIVE: The primary aim of this study was to assess the 2-year cumulative discontinuation rates of long-acting reversible contraceptive methods when provided free of charge for first-time users in a real-world setting. Additional aims were to describe factors associated with discontinuation and to evaluate the reasons for discontinuation. STUDY DESIGN: This is a retrospective register-based cohort study of 2026 nonsterilized women aged 15 to 44 years, who initiated a free-of-charge long-acting contraceptive method in 2013-2014 in the city of Vantaa. Removals within 2 years after method initiation and reasons for discontinuation were obtained from electronic health records and from national registers. We calculated the 2-year cumulative incidence rates of discontinuation with 95% confidence intervals for each method. Furthermore, we assessed crude and adjusted incidence rate ratios of discontinuation with 95% confidence interval by Poisson regression models comparing implants and copper intrauterine device with levonorgestrel-releasing intrauterine systems. RESULTS: During the 2 -year follow-up, 514 women discontinued, yielding a cumulative discontinuation rate of 28.3 per 100 women-years (95% confidence interval, 26.2-30.4). Among the 1199 women who initiated the levonorgestrel-releasing intrauterine system, the cumulative discontinuation rate was 24.2 per 100 women-years (95% confidence interval, 21.7-26.9); among the 642 implant users, 33.3 per 100 women-years (95% confidence interval, 29.5-37.4); and among the 185 copper intrauterine device users, 37.8 per 100 women-years (95% confidence interval, 31.0-45.7). Compared with women aged 30 to 44 years, women aged 15 to 19 years (adjusted incidence rate ratio, 1.58; 95% confidence interval, 1.17-2.14) and 20 to 29 years (adjusted incidence rate ratio, 1.35; 95% confidence interval, 1.11-1.63) were more likely to discontinue. We observed a higher discontinuation rate in women who had given birth within the previous year (adjusted incidence rate ratio, 1.36; 95% confidence interval, 1.13-1.65), spoke a native language other than Finnish or Swedish (adjusted incidence rate ratio, 1.31; 95% confidence interval, 1.06-1.63), and had a history of a sexually transmitted infection (adjusted incidence rate ratio, 1.62; 95% confidence interval, 1.07-2.46). No association was found in marital status, overall parity, history of induced abortion, socioeconomic status, education level, or smoking status. The most common reason for discontinuation was bleeding disturbances, reported by 21% of women who discontinued the levonorgestrel-releasing intrauterine system, by 71% who discontinued the implant, and by 41% who discontinued the copper intrauterine device. One in 4 women who discontinued the copper intrauterine device reported heavy menstrual bleeding, whereas only 1% who discontinued the levonorgestrel-releasing intrauterine system and none who discontinued implants reported this reason. Abdominal pain was the reported reason for discontinuation in 20% of both intrauterine device users and in only 2% who discontinued implants. CONCLUSION: At 2 years, the use of implants and copper intrauterine devices was more likely to be discontinued than that of the levonorgestrel-releasing intrauterine system. Women younger than 30 years and those who gave birth in the preceding year, spoke a native language other than Finnish or Swedish, or had a history of sexually transmitted infections were more likely to discontinue. The levonorgestrel-releasing intrauterine system was least likely to be removed owing to bleeding disturbances.

Reduced incidence and economic cost of hardware removal after ankle fracture surgery: a 20-year nationwide registry study.

Background and purpose - Open reduction and internal fixation (ORIF) is a treatment method for unstable ankle fractures. During recent years, scientific evidence has shed light on surgical indications as well as on hardware removal. We assessed the incidence and trends of hardware removal procedures following ORIF of ankle fractures.Patients and methods - The study covered all patients 18 years of age and older who had an ankle fracture treated with ORIF in Finland between the years 1997 and 2016. Patient data were obtained from the Finnish National Hospital Discharge Register.Results - 68,865 patients had an ankle fracture treated with ORIF in Finland during the 20-year study period between 1997 and 2016. A hardware removal procedure was performed on 27% of patients (n = 18,648). The incidence of hardware removal procedures after ankle fracture decreased from 31 (95% CI 29-32) per 100,000 person-years in the highest year 2001 (n = 1,247) to 13 (CI 12-14) per 100,000 person-years in 2016 (n = 593). Moreover, the proportion and number of removal operations performed within the first 3 months also decreased. The costs of removal procedures decreased from approximately €994,000 in 2001 to €472,600 in 2016.Interpretation - Removal of hardware after ankle surgery (ORIF) is a common operation with substantial costs. However, the incidence and cost of removals decreased during the study period, with a particular decrease in hardware removal operations within 3 months.

Access to IUD removal: Data from a mystery-caller study.

OBJECTIVE: This study describes access and barriers to intrauterine device (IUD) removal appointments in 10 mid-sized cities in the United States. STUDY DESIGN: This mystery caller study utilized a sampling frame of health centers in 10 mid-sized cities gathered from 3 search engines. We gathered data about the timing of the next available appointment, the requirements for additional appointments prior to IUD removal, and the out-of-pocket cost. We used descriptive statistics to describe the availability and cost of IUD removal visits, and compared results between primary care clinics and family planning or gynecology clinics. Any additional information regarding why a visit was not available or other requirements for IUD removal that was provided to the researcher was also recorded. RESULTS: Of 229 clinics included for analysis, 60.7% could offer an IUD removal appointment to the mystery caller, and the majority of these could provide an initial appointment within 2 weeks (61.2%), with a median of 10 days. Of clinics offering IUD removal, 17.3% required more than one visit before removing the IUD, and 43.2% confirmed that IUD removal would occur at the first visit. Five clinics (5.6%) reported that they would not remove an IUD that was not placed at their clinic. Sliding scale fees were offered at 16.3% of clinics. For the clinics that cited an out-of-pocket cost and did not offer sliding scale fees, the median cost of the IUD removal was $262, with a range of $50 to over $1000. Neither appointment availability nor cost differed between primary care and family planning or gynecology clinics. CONCLUSIONS: Overall, timely IUD removal appointments were available at the clinics we sampled, but both financial and clinic policy barriers to IUD removal were documented, including the need for multiple appointments and the total out-of-pocket costs. IMPLICATIONS: In our current climate focused on improving access to IUDs, it is essential to address and reduce barriers to IUD removal when desired, in order to preserve reproductive autonomy.

Unplanned Removal of Medical Devices in Critical Care Units in North West England Between 2011 and 2016.

BACKGROUND: The unplanned removal of medical devices poses a risk of harm to critically ill patients. OBJECTIVE: To determine rates, causes, and consequences of unplanned medical device removal, as well as factors mitigating harm to patients, in critical care units in the United Kingdom by reviewing patient safety incident reports. METHODS: Incidents of unplanned medical device removal in critical care units in North West England between 2011 and 2016 were retrospectively reviewed and classified. The incidents were classified by type of device displaced, staff and patient factors, causes and consequences of removal, and staff actions following removal. Displacement rates were calculated per 1000 patient days per unit. RESULTS: A total of 34 705 incident reports were reviewed, of which 1090 described unplanned device removal. The median rate of device removal was 0.7 (interquartile range, 0.4-2.2) per 1000 patient days per unit. Devices displaced most commonly included nasogastric tubes (317), central catheters (245), tracheostomy tubes (174), and endotracheal tubes (140). A total of 11 cardiac arrests were reported (8 associated with airway devices and 3 with central catheters). Factors contributing to displacement included initial placement (188), patient factors (563), and manual handling (238). Manual handling was cited in 49% of central catheter incidents and only 9% of nasogastric tube incidents. Patients' organic confusion was a factor in 16% of endotracheal tube and 80% of nasogastric tube removals. CONCLUSIONS: Unplanned device removal may cause patient harm and is often preventable. The causes and consequences depend on the type of device removed.

Real world data on Nexplanon® procedure-related events: final results from the Nexplanon Observational Risk Assessment study (NORA).

OBJECTIVES: We conducted this study to characterize the frequency of insertion-, localization- and removal-related events and their clinically significant consequences among Nexplanon® (etonogestrel radiopaque contraceptive implant) users in the United States during standard clinical practice. STUDY DESIGN: The Nexplanon Observational Risk Assessment (NORA) study was a large, prospective cohort study conducted in the United States. A total of 428 Health Care Professionals (HCPs) who had completed the Nexplanon clinical training program recruited women who were newly prescribed Nexplanon. We collected data on insertion-, localization- and removal-related events experienced during routine clinical practice via questionnaires completed by patients and HCPs. Recruitment began in December 2011 and follow-up ended in October 2017. Data analysis characterized the frequency of procedure-related events. RESULTS: We collected data on 7364 insertion procedures. The incidence of incorrect insertion (i.e., initially unrecognized non-insertion, partial insertion or deep insertion) was 12.6 per 1000 insertions (95% CI, 10.2-15.5). Pins and needles/numbness in the arm/hand/fingers was the most common patient-reported event. We obtained data on 5159 removal procedures, of which all were successful but one (due to the location of the implant in deep muscle tissue). No implants were localized outside the arm. The most common challenge reported by HCPs during implant removal was encasement of the implant within fibrotic tissue. CONCLUSIONS: Events associated with the insertion, localization and removal of the Nexplanon contraceptive implant were rare and their clinical consequences were generally not suggestive of serious injury. IMPLICATIONS: This study is the largest prospective evaluation of events associated with insertion and removal of Nexplanon during routine clinical practice. It demonstrates that complications associated with insertion and removal of Nexplanon are rare when performed by trained clinicians.

Trends in penile prosthesis implantation and analysis of predictive factors for removal.

PURPOSE: This study aims to analyze patient demographics, hospital characteristics, and clinical risk factors which predict penile prosthesis removal. We also examine costs of penile prosthesis removal and trends in inflatable versus non-inflatable penile prostheses implantation in the USA from 2003 to 2015. METHODS: Cross-sectional analysis from Premier Perspective Database was completed using data from 2003 to 2015. We compared the relative proportion of inflatable versus non-inflatable penile prostheses implanted. We separated the prosthesis removal group based on indication for removal-Group 1 (infection), Group 2 (mechanical complication), and Group 3 (all explants). All groups were compared to a control group of patients with penile implants who were never subsequently explanted. Multivariate analysis was performed to analyze patient and hospital factors which predicted removal. Cost comparison was performed between the explant groups. RESULTS: There were 5085 penile prostheses implanted with a stable relative proportion of inflatable versus non-inflatable prosthesis over the 13-year study period. There were 3317 explantations. Patient factors associated with prosthesis removal were non-black race, Charlson Comorbidity Index, diabetes, and HIV status. Hospital factors associated with removal included non-teaching status, hospital region, year of removal, and annual surgeon volume. Median hospitalization costs of all explantations were $10,878. Explantations due to infection cost $11,252 versus $8602 for mechanical complications. CONCLUSIONS: This large population-based study demonstrates a stable trend in inflatable versus non-inflatable prosthesis implantation. We also identify patient and hospital factors that predict penile prosthesis removal which has clinical utility for patient risk stratification and counseling.

Implantable cardioverter-defibrillator therapy in Australia, 2002-2015.

OBJECTIVES: To quantify the number of implantable cardioverter-defibrillator (ICD) procedures in Australia by year, patient age and sex, and to estimate age group-specific population rates and the associated costs. Design, setting: Retrospective observational study; analysis of Australian National Hospital Morbidity Database hospital procedures data. PARTICIPANTS: Patients with an ICD insertion, replacement, adjustment, or removal procedure code, July 2002 - June 2015. MAIN OUTCOME MEASURES: Number of ICD procedures by procedure year, patient age (0-34, 35-69, 70 years or more) and sex; age group-specific population procedure rates; number of procedures associated with complications. RESULTS: The number of ICD procedures increased from 1844 in 2002-03 to 6504 in 2014-15; more than 75% of procedures were in men. In 2014-15, the ICD insertion rate for people aged 70 years or more was 78.1 per 100 000 population, 22 per 100 000 for those aged 35-69 years, and 1.40 per 100 000 people under 35. The reported complication rate decreased from 45% in 2002-03 to 19% in 2014-15, partly because of a change in the coding of complications. The number of removals corresponded to at least 4% of the number of insertions each year. The aggregate cost of hospitalisations with an ICD procedure during 2011-14 was $445 644 566. CONCLUSION: ICD procedures are becoming more frequent in Australia, particularly in people aged 70 or more. Patterns of care associated with ICD therapy, particularly patient- and hospital-related factors associated with adverse events, should be investigated to better understand and improve patient outcomes.

Utilization of Public System for Gastric Bands Placed by Private Providers: a 4-Year Population-Based Analysis in Ontario, Canada.

Laparoscopic adjustable gastric band (LAGB) placement remains a common bariatric procedure. While LAGB procedure is performed within private clinics in most Canadian provinces, public health care is often utilized for LAGB-related reoperations. We identified 642 gastric band removal procedures performed in Ontario from 2011 to 2014 using population-level administrative data. The number of procedures performed increased annually from 101 in 2011 to 220 in 2014. Notably, 54.7% of the patients required laparotomy, and 17.6% of patients underwent a subsequent bariatric surgery. Our findings demonstrated that LAGB placement in private clinics resulted in a large number of band removal procedures performed within the public system. This represents a significant public health concern that may result in significant health care utilization and patient morbidity.

Surgical Outcomes of a New Low-Cost Nonvalved Glaucoma Drainage Device in Refractory Glaucoma: Results at 1 Year.

PURPOSE: The purpose of this study was to report the early outcomes in terms of efficacy and safety of a new, indigenously manufactured, low-cost nonvalved drainage device [AADI (Aurolab Aqueous Drainage Implant)] in the management of refractory glaucoma in the Indian population. METHODS: Retrospective review of consecutive patients older than 12 years, who underwent glaucoma drainage device surgery (GDD) using AADI, by a single fellowship-trained surgeon, between January 2014 and December 2016, who had at least 3 months of documented post-op follow-up. OUTCOME MEASURES: Primary-intraocular pressure (IOP).Secondary-number of antiglaucoma medication (AGM), LogMAR best corrected visual acuity (BCVA), and complications.Complete success was defined as IOP ≥5 mm Hg and ≤21 mm Hg or reduction of IOP by ≥20% from baseline without AGM; qualified success with use of AGM. Failure was defined as inability to meet IOP criteria, loss of perception of light, explantation or any additional glaucoma surgery. RESULTS: A total of 54 eyes of 51 patients were included. Mean follow up was 12.1±6.3 months. The IOP and number of AGM required was significantly lower at every visit postoperatively (P<0.001). Median LogMAR BCVA remained unchanged (P=0.5). Complications occurred in 22 patients (40.7%). Complete success was seen in 66.6%; overall success was 92.6%. CONCLUSIONS: New nonvalved GDD (AADI) surgery is effective in reducing IOP and need for AGM with a safety profile similar to published reports of prevailing GDDs. It thus has the ability to breach the cost barrier in low-to-middle income countries; further follow-up is required to determine sustainability over time.

The Disability Impact and Associated Cost per Disability in Women Who Underwent Surgical Revision of Transvaginal Mesh Kits for Prolapse Repair.

OBJECTIVES: The aim of this study was to investigate disability impact in patients and cost to the families of patients who have had complications of transvaginal prolapse mesh kits and underwent surgical revision. METHODS: Patients who developed complications of transvaginal mesh kits for prolapse and who had undergone vaginal prolapse mesh surgical revision/removal in 2009 to 2014 at a single institution were identified by Current Procedural Terminology codes. The group was invited to complete a phone survey pertaining to the initial vaginal mesh used for prolapse surgery utilizing Sheehan Disability Scale (scale 0-10) and Years of life Lived with Disability (YLDs) questionnaires. The data collected were used to estimate the disability and cost analysis. We used our data to estimate the economic and quality-of-life impact of vaginal mesh complications on patients in the United States RESULTS: Sixty-two patients (62/198 [31.2%]) were consented to participate and completed the questionnaires by phone. Extremely disabled patients were 18 (29%) of 62 of whole cases, and 5 (8%) of 62 reported that they had no disability after vaginal mesh surgery. The median for overall disability score after vaginal mesh procedure was 8 (which reflects marked disability on a scale of 0-10). The majority of patients missed a median of 12 months of their school or work because of their mesh complications. Thirty-seven (59.6%) of 62 did not improve after mesh removal. Twenty-one (33.9%) of 62 stated that their family income dropped because of productivity loss related to mesh complications. The mean time between vaginal mesh surgery and mesh removal procedure was 4.7 years. Sheehan Disability Scale scores are significantly correlated with YLDs outcomes. Patients' overall disability score showed a significant correlation with YLDs scores (P < 0.0001). CONCLUSIONS: Vaginal mesh for prolapse reduction complications had a sustained disability impact that continued despite mesh removal. Likewise, the complications were associated with increased economic burden on the families of the effected individuals and a drop in the family income in more than one third of the families.

[Operative treatment in orthopedics and trauma surgery : Are more operations carried out in Germany?] / Operative Versorgung in Orthopädie und Unfallchirurgie : Wird in Deutschland immer mehr operiert?

BACKGROUND: Since 2005, when the Diagnosis-Related Group (DRG) system was introduced, an increasing number of surgical procedures have been reported in Germany. In particular, the numbers of elective arthroplasty and spinal surgery procedures have been controversial. OBJECTIVES: The focus of this study was analyzing the development of spinal surgery, arthroplasty, and fracture management. MATERIALS AND METHODS: We analyzed the database for all musculoskeletal operating procedure codes (OPS codes 5­78 to 5­86) from 2005 to 2013 collected by the German Federal Statistical Office. RESULTS: With an increase in total patient numbers of 12.8%, there was a rise in in-patient musculoskeletal procedures of 43.5%; the highest increase in procedures was found in spinal surgery (130%). Despite an ageing population, the numbers of hip- and knee arthroplasty procedures initially decreased after 2011 and after 2009 respectively. The number of osteosyntheses showed a slight increase (16%), whereas the number of (elective) implant removals declined (-7%). An increase in novel techniques was noticeable, such as locked plate osteosynthesis (251%), shoulder arthroplasty (402%) or the use of bone substitutes in spinal surgery (+2,011%). CONCLUSIONS: Despite generally increasing volume growth, the numbers of hip and knee arthroplasty cases decreased. In addition to an ageing population and potential economic incentives, technical innovations and new implant systems should be considered when discussing increasing case numbers.

Factors Associated With Removal of Urinary Catheters After Surgery.

Publicly available data from the Centers for Medicaid & Medicare Services were used to analyze factors associated with removal of the urinary catheter within 48 hours after surgery in 59 Massachusetts hospitals. Three factors explained 36% of the variance in postoperative urinary catheter removal: fewer falls per 1000 discharges, better nurse-patient communication, and higher percentage of Medicare patients. Timely urinary catheter removal was significantly greater in hospitals with more licensed nursing hours per patient day.

Implant Failure Rates and Cost Analysis of Contoured Locking Versus Conventional Plate Fixation of Distal Fibula Fractures.

The authors analyzed 330 consecutive Weber B distal fibula fractures that occurred during a 3-year period and were treated with either a contoured locking plate or a conventional one-third tubular plate to compare the cost and failure rates of the 2 constructs. The primary outcomes were failure of the distal fibular implant and loss of reduction. Secondary outcomes were surgical wound infection requiring surgical debridement and/or removal of the fibular implant, and removal of the fibular plate for persistent implant-related symptoms. No failure of the fibular plates or distal fibular fixation occurred in either group. A total of 5 patients required surgical revision of syndesmotic fixation within 4 weeks of the index surgery. Of these patients, 1 was in the contoured locking plate group and 4 were in the one-third tubular plate group (P=.610). The rate of deep infection requiring surgical debridement and/or implant removal was 6.2% in the contoured locking plate group and 1.4% in the one-third tubular plate group (P=.017). The rate of lateral implant removal for either infection or symptomatic implant was 9.3% in the contoured locking plate group and 2.3% in the one-third tubular plate group (P=.005). A typical contoured locking plate construct costs $800 more than a comparable one-third tubular plate construct. Based on a calculated estimate of 60,000 locking plates used annually in the United States, this difference translates to a potential avoided annual cost of $50 million nationally. This study demonstrates that it is possible to treat Weber B distal fibula fractures with one-third tubular plates at a substantially lower cost than that of contoured locking plates without increasing complications. [Orthopedics. 2017; 40(6):e1024-e1029.].

Semi-Automatic Electronic Stent Register: a novel approach to preventing ureteric stents lost to follow up.

BACKGROUND: Ureteric stents are indispensable tools in modern urology; however, the risk of them not being followed-up once inserted poses medical and medico-legal risks. Stent registers are a common solution to mitigate this risk; however, manual registers are logistically challenging, especially for busy units. METHODS: Western Sydney Local Health District developed a novel Semi-Automatic Electronic Stent Register (SAESR) utilizing billing information to track stent insertions. To determine the utility of this system, an audit was conducted comparing the 6 months before the introduction of the register to the first 6 months of the register. RESULTS: In the first 6 months of the register, 457 stents were inserted. At the time of writing, two of these are severely delayed for removal, representing a rate of 0.4%. In the 6 months immediately preceding the introduction of the register, 497 stents were inserted, and six were either missed completely or severely delayed in their removal, representing a rate of 1.2%. A non-inferiority analysis found this to be no worse than the results achieved before the introduction of the register. CONCLUSION: The SAESR allowed us to improve upon our better than expected rate of stents lost to follow up or severely delayed. We demonstrated non-inferiority in the rate of lost or severely delayed stents, and a number of other advantages including savings in personnel costs. The semi-automatic register represents an effective way of reducing the risk associated with a common urological procedure. We believe that this methodology could be implemented elsewhere.

Six- and twelve-month documented removal rates among women electing postpartum inpatient compared to delayed or interval contraceptive implant insertions after Medicaid payment reform.

OBJECTIVE: This study aims to document 6- and 12-month removal rates for women receiving the contraceptive implant inpatient postpartum versus those receiving the same contraceptive method during an outpatient visit, in a setting where postpartum inpatient long-acting reversible contraceptive (LARC) services (devices plus provider insertion costs) are reimbursed by Medicaid. STUDY DESIGN: We conducted a retrospective cohort study among Medicaid-enrolled women using medical record review for all women receiving the etonogestrel implant between July 1, 2007 and June 30, 2014. We compared the percentage of women with the implant removed at 6 and 12 months as well as reasons for early removal, for inpatient postpartum implant insertions vs. delayed postpartum or interval outpatient implant insertions. RESULTS: A total of 4% of women (34/776 insertions) had documented implant removal within 6 months post-insertion, with no difference between postpartum inpatient and outpatient (delayed postpartum or interval). A total of 12% (62/518 insertions) of women had documented implant removal within 12 months. A lower percentage of women with postpartum inpatient insertions had the implant removed at 12 months post-insertion, compared to outpatient insertions (7% vs. 14%, p=.04). After controlling for age, parity, race and body mass index, women with postpartum inpatient insertions were less likely to have the implant removed within 12 months (OR=0.44, 95% CI 0.20-0.97). The most commonly stated reason for removal was abnormal uterine bleeding, regardless of insertion timing. CONCLUSION: In a setting with a Medicaid policy that covers postpartum inpatient LARC insertion, a low percentage of women who received an implant immediately postpartum had it removed within 1 year of insertion. IMPLICATIONS: A Medicaid payment policy that removes institutional barriers to offering postpartum inpatient contraceptive implants to women free-of-charge may facilitate meeting women's desires and intentions to delay subsequent pregnancy, as evidenced by low removal rates up to 12 months post-insertion. Further research with women is needed to assess how these services meet their postpartum contraceptive needs and desires to postpone or prevent subsequent pregnancy.

Gaps in monitoring systems for Implanon NXT services in South Africa: An assessment of 12 facilities in two districts

Background. Implanon NXT, a long-acting subdermal contraceptive implant, was introduced in South Africa (SA) in early 2014 as part of an expanded contraceptive method mix. After initial high levels of uptake, reports emerged of frequent early removals and declines in use. Monitoring of progress and challenges in implant service delivery could identify aspects of the programme that require strengthening. Objectives. To assess data management and record keeping within implant services at primary care facilities. Methods. We developed a checklist to assess the tools used for monitoring implant services and data reporting to district offices. The checklist was piloted in seven facilities. An additional six high-volume and six low-volume implant insertion clinics in the City of Johannesburg (CoJ), Gauteng Province, and the Dr Kenneth Kaunda District, North West Province, were selected for assessment. Results. All 12 facilities completed a Daily Head Count Register, which tallied the number of clients attending the clinic, but not information about implant use. A more detailed Tick Register recorded services that clinic attendees received, with nine documenting number of implant insertions and six implant removals. A more specific tool, an Insertion Checklist, collected data on insertion procedures and client characteristics, but was only used in CoJ (five of six facilities). Other registers, which were developed de novo by staff at individual facilities, captured more detailed information about insertions and removals, including reasons. Five of six low-volume insertion facilities used these registers, but only three of six high-volume facilities. No facilities used the form specifically developed by the National Department of Health for implant pharmacovigilance. Nine of 12 clinics reported data on numbers of insertions to the district office, six reported removals and none provided data on reasons for removals. Conclusion. For data to inform effective decision-making and quality improvement in implant services in SA, standardised reporting guidelines and data collection tools are needed, reinforced by staff training and quality assessment of data collection. Staff often took the initiative to fill gaps in reporting systems. Current systems are unable to accurately monitor uptake or discontinuation, or identify aspects of services requiring strengthening. Lack of pharmacovigilance data is especially concerning. Deficiencies noted in these monitoring systems may be common to family planning services more broadly, which warrants investigation.

Cost-benefit analysis of establishing an inferior vena cava filter clinic.

PURPOSE: Adverse events associated with retrievable inferior vena cava filters (IVCFs) have generated an increased interest in improving IVCF retrieval rates to improve patient safety and quality care. This study aims to demonstrate the cost-benefit of implementing an IVCF clinic to improve patient care in an institution in the United States. METHODS: An IVCF clinic was established at a single institution in September 2012 and for ten months referring physicians were contacted to facilitate retrieval when appropriate. Additionally, a retrospective review was conducted on filter placements over the eight preclinic months. Cost-benefit analysis was conducted by creating a model, which incorporated the average cost and reimbursement for permanent and retrievable IVCFs. RESULTS: A total of 190 IVCFs (152 retrievable IVCFs and 38 permanent IVCFs) were implanted during the IVCF clinic period. Twenty-nine percent of the retrievable IVCFs were successfully retrieved compared to 10 of 119 retrievable IVCFs placed during the preclinic period (8.4%). Cost-benefit analysis, using the average of the institution's six most common reimbursement schedules, demonstrated an average net financial loss per permanent or retrievable IVCF not removed. However, a net financial gain was realized for each retrievable IVCF removed. The additional hospital cost to maintain the IVCF clinic was offset by removing an additional 3.1 IVCFs per year. CONCLUSION: An IVCF clinic significantly increases retrieval rates, promotes patient safety, and is economically feasible. Given the adverse event profile of retrievable IVCFs, strategic efforts such as these ultimately can improve quality care for patients with in-dwelling IVCFs.

Hidden Morbidity of Ventral Hernia Repair with Mesh: As Concerning as Common Bile Duct Injury?

BACKGROUND: Ventral hernia repair with mesh is increasingly common, but the incidence of long-term complications that necessitate mesh explantation is unknown. We aimed to determine the epidemiology of mesh explantation after ventral hernia repair and to compare this with common bile duct injury, a dreaded complication of laparoscopic cholecystectomy. STUDY DESIGN: We evaluated a retrospective cohort of patients undergoing ventral hernia repair by linking the all-payers State Inpatient Databases and State Ambulatory Surgery Databases for New York, California, and Florida. We followed patients longitudinally from 2005 to 2011 for the primary end point of mesh explantation, designated by concurrent procedure codes for ventral hernia repair and foreign body removal. We determined time to mesh explantation and calculated cumulative costs for surgical care, comparing these with historical data for common bile duct injury. RESULTS: During the study period, 619,751 patients underwent at least one ventral hernia repair (91% open, 9% laparoscopic). In a mean follow-up of 3 years, 438 patients (0.07%) had mesh removed at a median of 346 days after repair. Median cumulative cost for patients requiring mesh explantation was $21,889 vs $6,983 without (p < 0.01). Rates of mesh explantation and costs were on par with laparoscopic common bile duct injury, based on published data, but occurred later in the postoperative course. CONCLUSIONS: By this conservative estimate, complications of ventral hernia repair with implantable mesh are comparably as frequent as for common bile duct injury, but occur later in a patient's experience. Long-term follow-up is critically necessary to fully understand the ramifications of implanted devices.