Learning from the report of the independent medicines and medical devices safety review: "first do no harm".

This is a review of the learning points from the Independent Medicines and Medical Devices Safety Review,1 chaired by Baroness Julia Cumberlege CBE DL. This system-wide review was initiated by the then Secretary of State for Health and Social Care, following patient-led campaigns. It looked at how the "healthcare system reacted as a whole, and how that response can be made more robust, speedy and appropriate".We aim to highlight the learning points for doctors in Obstetrics and Gynaecology as these are relevant to our current practice and future changes in our healthcare system. These are: Aims of the review: why it was initiated and how it was conductedOverarching themes and missed opportunities to prevent avoidable harmThree clinical scenarios: their histories, issues and adverse events associated with their use and the current response in Scotland The hormone pregnancy test - PrimodosThe anti-epileptic drug - sodium valproateSurgical mesh for prolapse & incontinenceThe recommendations made by the review and implementation guidanceResponses to the review, such as apologies issued by BSUG2/BAUS3/RCOG,4 and compensations schemes such as the Scottish scheme as recommended by the review.

Women's Experiences of Urinary Tract Infections and Impact on Life: An Exploratory Qualitative Study.

IMPORTANCE: Despite high incidences of urinary tract infections (UTIs), little is known about how bothersome symptoms are and the effects on women's life and sexual activity, leaving a gap in our understanding of the physical and emotional effects of UTIs on women. OBJECTIVES: This initial exploratory and descriptive study analyzes women's experiences of UTI and their perceived impact on quality of life. STUDY DESIGN: Qualitative interviews were undertaken with 23 women who had experienced at least 1 UTI, recruited from different settings-primary care, general gynecology clinics, urogynecology clinics, and online via social media. Data were analyzed thematically. RESULTS: Three themes described women's experiences of UTI: Women in all groups reported a wide range of physical symptoms and described the financial and psychological effects of UTIs. These effects seemed worse in women recruited via social media who also reported experiencing strong emotions and worries about close family members. Urinary tract infection support groups were considered useful, with women being grateful for consultations with alternative health practitioners and presuming safety of natural products. CONCLUSIONS: Having a UTI appeared to affect women in a variety of ways, ranging from having different physical symptoms to being psychologically affected by these symptoms, which affected their quality of life in different ways. This research contributes to the growing evidence on how UTIs affect women, specifically further expanding on the impact on women in a range of settings-in the community and different health care settings.

Use of Magnetic Resonance Imaging in women with suspected complications following insertion of implants for pelvic organ prolapse and stress urinary incontinence surgery.

OBJECTIVE: To evaluate the role of Magnetic Resonance Imaging (MRI) in women presenting with suspected implant complications following surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). STUDY DESIGN: Retrospective single-centre cohort study in a designated tertiary referral centre. All women with vaginally and/or abdominally placed implants for POP or SUI who were referred with suspected mesh complications, and investigated with an MRI scan, between January 2018-October 2020 were included in the study. RESULTS: 97 women were identified over this time-period with a total of 123 implants, a median age of 55 years (Range: 34-79) and an average insertion to presentation time of 84 months (Range: 2-300). 78% (74) had one implant in situ, with the remainder having at least 2 in situ. Transobturator tapes (TVT-O/TOT) were the most common implants [35% (43)]. Chronic Pelvic or abdominal pain was the most common clinical symptom [73.2% (71/112 primary complaints)] with provoked tenderness on examination being the most common clinical finding [27.8% (32/115 clinical findings)]. MRI was more likely to detect abdominally placed implants [100% (all 30)] and Retropubic Tapes [89% (16/18)] when compared to Transvaginal POP implants [87.5% (28/32)] and TVT-O/TOT [67% (29/43)]. MRI identified both cases of Sacrocolpopexy mesh rupture as well as all 11 cases of infection (100%). In 91% (10/11) of these cases, MRI revealed the infection to be more widespread than clinical findings initially suspected. Cohen's Kappa demonstrated excellent correlation between MRI and surgical findings in cases with implant related infection, rupture and normal findings (κ = 1; z = 4.58; p = 0.00000459). CONCLUSION(S): MRI can be a useful tool in assessment and management of patients with complications from implants. MRI can detect infection that may be more extensive that is initially clinically apparent in the outpatient setting. Abdominal implants appear to be easier to detect than transvaginal meshes and trans obturator tapes.

The Impact of Vaginal Laser Treatment for Genitourinary Syndrome of Menopause in Breast Cancer Survivors: A Systematic Review and Meta-analysis.

INTRODUCTION: Genitourinary syndrome of menopause (GSM) is caused by hypo-estrogenism, resulting in vaginal dryness, pain, dyspareunia, and urinary tract infection. It is more severe and common in breast cancer (BC) survivors owing to the severity of induced menopause following treatment (ie, chemotherapy, GnRH agonists/anti-estrogen therapy). It has a detrimental effect on quality of life. The gold standard therapy is topical estrogen, which is highly effective; however, it is contraindicated in patients with BC owing to concerns with recurrence. Recently, vaginal laser therapy has been used to restore vaginal mucosal thickness, lubrication, and elasticity with good effect in menopausal women with GSM. The aim of this study is to assess the impact of vaginal laser therapy on BC-associated GSM. MATERIALS AND METHODS: This study is a systematic review and meta-analysis. RESULTS: A total of 48 papers were identified, revealing 10 observational studies of GSM symptoms before and after vaginal laser therapy with no randomized trials. Vaginal laser was effective in treating GSM in BC survivors with improvement in the Vaginal Health Index and the Visual Analogue Scale score for dyspareunia and vaginal dryness, sexual function, and overall satisfaction in the short term with minimal adverse events. CONCLUSION: Vaginal laser may be effective in treating GSM in BC survivors in the short term, but there are no long-term data on safety and efficacy. More research is needed looking at longer term follow-up, health economic costs, and sub-group analysis as well as the complex interplay between GSM and the other negative impacts of BC therapy on intimate relationships.

Efficiency of using a vaginal drain after hysterectomy: A systematic review.

Objective Hysterectomy is the second most frequently performed surgical procedure for women of reproductive age topped only by caesarean section. Hysterectomies may be associated with a significant risk of ultrasonographically detected vault haematomas in up to 59% with consequent postoperative morbidity. The aim of this systematic review was to compare women who had a vaginal drain placed intraoperatively after a hysterectomy and the impact on peri and postoperative outcomes related to vault haematomas. Study Design Electronic searches of AMED, BNI, CINAHL, EMBASE, HBE, HMIC, Medline, PsycINFO and PubMed, Cochrane register of controlled trials (CCTR), Cochrane database of systematic reviews (CDSR) CINAHL and Google scholar were performed. A systematic review and meta-analysis of studies comparing women with and without a vaginal drain after a hysterectomy and the impact on different outcomes was carried out. Results Ten studies involving 1778 women, 811 with a vaginal drain and 967 without a drain, were included in the meta-analysis. This suggests that the use of a vaginal drain after hysterectomy may significantly reduce the incidence of vault haematoma (OR 0.22, 95% CI 0.08 - 0.57) and febrile morbidity (OR 0.54, 95% CI 0.40 to 0.73), non- significantly reduce the rate of usage of antibiotics (OR 0.80, 95% CI 0.46-1.42) and makes no difference to the length of hospital stay (MD 0.12, 95% CI -0.14 to 0.38). Conclusion The use of a vaginal drain after hysterectomy could reduce the incidence of vault haematoma and febrile morbidity.

Efficiency of using a Foley catheter as a pelvic drain in vaginal hysterectomy.

OBJECTIVES: Vaginal hysterectomy can be associated with a significant risk of vault haematomas with consequent postoperative morbidity. The aim of this study was to assess the use of a Foley Catheter as a vaginal drain in premenopausal women undergoing a vaginal hysterectomy and the impact on different outcomes including development of vault haematoma, length of hospital stay, antibiotics usage, readmissions to the hospital and febrile morbidity in the immediate postoperative period. STUDY DESIGN: This study was conducted at a tertiary teaching hospital and was a retrospective cohort study of women undergoing a vaginal hysterectomy. The study compared 52 women in the study group with a Foley catheter drain to 51 age matched controls without a drain who underwent surgery for similar indications. Outcomes were compared using the Chi square test and student t-test. RESULTS: Comparing women with a drain to those without demonstrated a statistically significant difference with worse outcomes for all parameters in women without a drain: evidence of vault haematomas (0 vs 8; p = 0.0025); length of hospital stay over 2 days (3 vs 15; p = 0.001); discharge with antibiotics for vault haematomas (5 vs 0; p = 0.028) and readmission rates (0 vs 7; p = 0.005). There was no statistical difference in the number of women with temperatures over 38 °C (4 vs 2; p = 0.3) in either group. CONCLUSION: A Foley catheter used as a pelvic drain following a vaginal hysterectomy reduces postoperative complications associated with vault haematomas with shorter hospital stay, lower antibiotic usage and lower readmission rate.