- Significant decrease In minimally invasive hysterectomies and myomectomies( 6 hospitals, 98 surgeons) during 8 months after FDA warning on use of power morcellation
- Risks with morcellation:
- If unknown malignant tumour: Dissemination
- If a benign tumour: Parasitic myoma with pain and/or bowel obstruction
- The possibility of iatrogenic endometriosis.
- Iatrogenic injury
Medical-legal review of power morcellation (Ton et al 2015)
Findings: Despite best intentions, gynaecologists who continue to use power morcellation devices expose themselves to liability.
Outcome: Significant change in the informed consent process, and surgical technique/approach.
Companies pulled out devices, insurance companies stopped paying for procedure and no of hospitals stopped using devices
Implications: Can we still perform power morcellation as per FDA guidelines by maintaining patient safety and avoiding medicolegal liability?
- Recently FDA approved in bag morcellation, but still stands by its warning, patients need to understand risks
- FDA wants patients to understand that no guarantee to stop the spillage with any technique for in bag morcellation
- However, even in traditional surgical techniques there is chance for fluid spread- further refinement required
Current techniques for specimen retrieval
- Rip stop nylon bag
- Nylon bag
- Plastic bag
- Hand glove modified into bag
- Posterior Colpotomy for small to medium size specimen retrieval.
- Vaginal morcellation.
- Minilap morcellation devices
The search for the ideal technique/device is still on.
- In-bag morcellation (IBM) offers a viable option to retrieve the specimen without risking dissemination of an unknown/occult malignancy during gynaecological laparoscopy.
- WA Gynaescope technique is a step forward in the currently accepted techniques for IBM.
Single Centre Study ( Sept 2015- July 2016, N=75)
- Multiport laparoscopic subtotal/total hysterectomy or myomectomy.
- Power morcellation performed in an insufflated specimen retrieval bag (SRB), acting as an artificial peritoneal cavity, without additional port/port site extension.
- Methylene blue was initially used for staining the specimen and peritoneal cavity to check for dissemination and spillage.
- The SRB was then inspected to rule out perforations apart from those used for balloon port. In addition, GT allowed balloon port placement and removal under direct vision preventing risk factor for spillage and viscus injury.
- SRB inserted ( 15mm, Endo Catch 2 Autosuture, Covidien) for specimen retrieval through the supra-pubic port
- Psudopneumopereritonium created in SRB - CO2 flows in pulsatile waveform
- Optical balloon tip port with trocar ( KII Shielded Bladed Access System) reinserted from right lateral port into SRB This procedure happens under direct vision from 10mm umbilical port.
- Balloon inflated to maintain the seal
- Morcellation performed from Suprapubic incision under direct vision from 5mm scope inserted through right lateral optical port.
- SRB is withdrawn under direct vision enabling no spill of any content
All patients underwent GT during laparoscopic IBM without complications including specimen dissemination or visceral injury.
- None of the procedure was associated with SRB failure.
- Dissemination was avoided due to the use of SRB in a case which was later confirmed as leiomyosarcoma on histopathology.
- Further staging surgery for the same patient in tertiary institute did not show any evidence of dissemination/advancement of staging.
- GT during laparoscopic IBM is a safe, reproducible, valuable addition to the current options for specimen retrieval during minimally invasive surgery.
- GT optimizes patient safety by allowing direct visualization of surrounding structures while keeping blades away from the viscera
- Further large prospective studies are required to assess the safety and efficacy of GT.
Contained power morcellation within an insufflation isolation bag, Cohen et al, Obstet Gynecol 2014
Power morcellation inside a secure endobag: a pilot study. Anapolski M, Panayotopoulos D, Alkatout I, Soltesz S, Mettler L, Schiermeier S, Hatzmann W, Noé G. Minim Invasive Ther Allied Technol. 2016 Aug;25(4):203-9.
Sydney contained in bag morcellation for laparoscopic myomectomy.Kanade TT, McKenna JB, Choi S, Rosen DM, Cario GM, Chou D., J Minim Invasive Gynecol.Nov-Dec 2014.