Avoiding Mesh Disasters: Tips and Tricks for Success and Handling Complications

Transcription

1 Avoiding Mesh Disasters: Tips and Tricks for Success and Handling Complications Karyn S. Eilber, M.D. Cedars-Sinai FPMRS Associate Professor, Cedars-Sinai Dept of Surgery Associate Director, Urology Residency Training Program

2 Disclosures Investigator Aquinox, Astellas, Boston Scientific Consultant Allergan

3 Surgery for POP Use of mesh for cystocele repair has greater anatomic cure rates and decreases recurrence (Julieto et al 2016, Lamblin et al 2014) Recurrence rate high for anterior compartment and related to apex (Eilber et al 2012), but no easy and effective native tissue vaginal procedure to suspend uterus Sacrocolpopexy has lower rate of recurrent vault prolapse vs. vaginal SSL colpopexy but longer surgery, longer return to ADL, increased cost (Maher et al. 2008)

4 Use of Surgical Mesh Use of surgical mesh to repair abdominal hernias Use of mesh (indicated for hernia repair) for abdominal repair of POP Use of surgical mesh to repair SUI and POP (TV) FDA cleared Mesh specifically for use in POP Mesh for POP incorporated into kits *FDA safety communications 1950s 1970s 1990s * 2011* FDA Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse July 2011

5 FDA Safety Communication Inform clinicians and patients of adverse events related to urogynecologic use of surgical mesh 1 Provide recommendations on how to mitigate risks 1 Provide recommendations on how to counsel patients 1-13 questions patients should ask their doctor before they agree to have surgery in which mesh will be used. 2 The FDA continues to evaluate the effects of using surgical mesh for the treatment of SUI and will report about that usage at a later date Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse, July 2011, CDRH p8 2. FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse. July 13, and Notices/ucm htm 7

6 FDA Safety Communication Reclassification of transvaginal surgical mesh products for POP to Class III (pre-market approval) and require manufacturers to conduct post-market surveillance studies. Surgical mesh devices for SUI remain in Class II. No additional post-market surveillance studies necessary for retropubic and TOT slings. Pre-market studies for new devices and additional post-market surveillance studies for mini-slings. 1

7 FDA Physician Recommendations Obtain specialized training for each mesh placement technique Be aware of the risks of surgical mesh RECOGNIZE THAT IN MOST CASES, POP CAN BE TREATED SUCCESSFULLY WITHOUT MESH Inform patients mesh is permanent Inform patients about potential serious complications and effect on QOL (pain, dyspareunia, scarring, narrowing of the vagina) Provide patient with a copy of the patient labeling from the surgical mesh manufacturer (IFU, Instructions for Use) 4

8 FDA Patient Recommendations Questions patients should ask: Ask your surgeon about all POP treatment options Why is surgical mesh being chosen for my repair? Why do you think I am a good candidate for surgical mesh? If surgical mesh will be used, is there special patient information that comes with the product, and can I have a copy? If surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy? If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications? (actually listed twice on same web page) 4

9 FDA Patient Recommendations Questions patients should ask: What are the pros and cons of using surgical mesh in my particular case? If surgical mesh will be used, is there special patient information that comes with the product, and can I have a copy? If surgical mesh is to be used, what s been your experience with this particular product and with treating potential mesh complications? What can I expect to feel after surgery and for how long? Surgical Mesh: FDA Safety Communication Information on Surgical Mesh for Hernia Repairs 4

10 What do these have in common? Mass hysteria driven by attorneys

11 Legal vs Medical Claims In 1992, silicone implants were banned for 14 years Medical community split over controversy Dow Corning paid over $1.2 billion in settlements for claims that silicone implants caused a variety of medical ailments What are the best breast implants made of today?

12 Mesh Litigation >73,000 patients filed product liability claims (prolapse and slings) 1% random sample (739) claims analyzed (Perkins/Souders et al, AUA 2016) 63% slings, 13% POP, 23% both Time from surgery to claim date 5.3 years for slings, 5.3 years for POP, 4.8 years for both 88% surgeons not FPMRS

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14 In response to sling litigation? AUGS/SUFU Position Statement on Mesh Midurethral Slings for Stress Urinary Incontinence The polypropylene mesh midurethral sling is the recognized worldwide standard of care for the surgical treatment of stress urinary incontinence. The procedure is safe, effective, and has improved the quality of life for millions of women.

15 When do I use mesh? For 99% of slings Recurrent POP and patient wants vaginal repair Significant cystocele and patient wants vaginal repair but no hysterectomy Someone who already has silicone implants

16 When do I NOT use mesh? Any patient who has had a mesh complication Sacrocolpopexy and risk of infection Any patient for whom dyspareunia is their worst fear Any patient who cannot comprehend the FDA safety communication

17 Potential complications Intraoperative: hemorrhage, visceral injury Perioperative: hemorrhage, pain/dyspareunia, infection, voiding dysfunction, vaginal mesh exposure* Long-term: recurrent prolapse *ONLY MESH SPECIFIC COMPLICATION

18 INTRAOPERATIVE Increased EBL is significant risk for mesh exposure Most venous bleeding Pressure, hemostatic agents Vaginal packing Prevention: Identify correct plane Be wary of elderly women and ketorolac/bridging anticoagulation Hemorrhage POSTOPERATIVE Don t rush to operate for bleeding It s a confined space Transfuse if needed Replace vaginal packing Bleeding around POD 7 likely liquefied hematoma

19 Visceral injury INTRAOPERATIVE Bladder perforation during retropubic sling NOT a complication Don t hesitate to open and/or call for consultants Prevention Know your anatomy Cysto with IV dye after mesh prolapse surgery POSTOPERATIVE Have high suspicion Patients recover quickly after vaginal surgery Don t hesitate to order imaging

20 Intraoperative bladder perforation Cystotomy during dissection Close bladder in 2 layers and leave Foley Cystogram if concern regarding integrity of repair or want to remove Foley early Mesh (probably )should not be placed on cystotomy site Consider interposing or only using biologic graft Bladder perforation with mesh Reposition if just sling Do not place POP mesh if injury not identified and repaired

21 Unrecognized bladder perforation High suspicion for mesh erosion (missed injury?) if persistent UTI Endoscopic removal of mesh usually just delays open removal Image upper tracts

22 Ureteral injury Confirm absence of ureteral injury intraoperatively with cysto (at least with vaginal cases) and document ureteral efflux Transection vs perforation vs deviation Pass wire vs RPG Attempt antegrade study/stent if no extravasation Stay within 2 cm medial to ischial spine when suture/mesh placed Renal ultrasound if persistent groin/flank pain, abdominal distension, patient just not doing well Reimplant if recognized within first week after surgery

23 Bowel injury Rectal stent or packing can facilitate dissection and mesh placement Close rectum in 2 layers if injury recognized Have high suspicion if patient distended, nauseated, or just not doing well CT best imaging

24 Pain Most pain self-limited Intraop and postop ketorolac/oral anti-inflammatories Intraop injection of local anesthesia (groins for TOT) You only get pain when you operate for pain Anti-inflammatories, amitriptyline, and pelvic floor PT cures almost all pain Often only need to release tension on mesh arm Consider infection if pain consistently improves with antibiotics then returns (will need mesh removal)

25 Dyspareunia Vaginal mesh exposure usually diagnosed because of his pareunia Some argue better than no -pareunia Can occur with atrophy and sexual inactivity Mesh does NOT degrade and contract (Thames et al 2016, Dietz et all 2011) Document presence of any dyspareunia preop

26 Dyspareunia Majority of dyspareunia without mesh exposure resolves Aggressive local estrogen Examine for trigger points Vaginal dilation if not sexually active on a regular basis Need to instruct patient Rarely relaxing incisions needed Best prevention: avoid overtensioning of mesh and narrowing posterior vagina

27 Infection Infection of mesh rare but usually requires removal Antibiotic prophylaxis 1 st generation cephalosporin at time of surgery 24 hours antibiotics if patient stays overnight Suspect infection: Extreme tenderness at mesh site and no tension Persistent pain with negative cultures that only improves with antibiotics

28 Infection Difficult to diagnose infection in patients with chronic pain syndromes In this scenario, you are asking yourself why you implanted mesh in the first place MRI may be helpful Have suspicion for osteomyelitis if back pain after sacrocolpopexy Remove as much mesh as possible and irrigate a lot with antibiotic solution Usually unnecessary to remove all mesh

29 Urethral mesh Likely missed injury because urethra not distended with fluid and inspected during cystoscopy If recognized intraop, remove mesh and reconstruct if needed Endoscopic attempt at removal not unreasonable but usually unsuccessful Consider placement of autologous fascial sling at time of removal if severe SUI preop

30 Vaginal mesh exposure Erosion vs exposure Technical vs nature of disease Identify correct plane of dissection Avascular Thick vaginal flaps Avoid total hysterectomy and placement of mesh directly on cuff if concomitant hys

31 Vaginal mesh exposure Can occur many months after surgery Especially if pt premenopausal at time of surgery Common symptoms: Vaginal spotting Patient feels something His -pareunia Trial of vaginal estrogen if small Consider immediate excision if patient sexually active

32 Recurrent prolapse MRI useful to diagnose what is prolapsing Strongly consider abdominal repair if failed vaginal repair with mesh What to do if failed sacrocolpopexy? Pessary Transvaginal enterocele repair/mesh Colpocleisis

33 What is the single best treatment for mesh complications?? COMMUNICATION Talk to your patient Show empathy Women trust women

34 How to avoid a mesh disaster Discuss all treatment options preop Inform patients of FDA safety communications Dissect in same plane as abdominal surgery Avoid total hysterectomy and excessive blood loss Vaginal estrogen Respect the mesh Consult with your colleagues and mentors Thank you