aA nha g2> Sail ymalhatoo Chief Executive office Circular No. (11) 2018 To All Medical Device Companies and Healthcare Facilities Date: 23 October 2018 Sub: Prohibition of Importation of Transvaginal Mesh The National Health Regulatory Authority would alert all medical devices companies and healthcare facilities that it is prohibited to import the Transvaginal Mesh used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI. Many complains were reported from the use of surgical mesh included vaginal mesh erosion (also called exposure, extrusion or protrusion), pain, infection, urinary problems, bleeding, and organ perforation. There were also reports of recurrent prolapse, neuro- muscular problems, vaginal scarring/shrinkage. Therefore it is highly recommended to all medical devices companies and healthcare facilities to be aware of the severity of use this type of treatment and the medical consequences that can be caused after the surgical mesh. NHRA issue a warning of import, sell and use the Transvaginal Mesh and request all healthcare facilities to report to NHRA in case of having this product. Your cooperation is highly appreciated in improving health services in the Kingdom. dada ‘a y opadlistos Kingdom of Banrain 2018 4d (11) of) pyri A ggal) CLe jtiaaallg 5 5g) GIS ear ool! Ayareal Cilia gall y £2018 358i 23 sda Qe Laced Ghadlly gall piaitl Gabel) Zig!) asa Ouplly Syl Lastly 35g) CASS Mell Cae i Leadicall Alig 26325) I yl gis pil akg anya eLcael age La) 4LLLGD 2 ie! sian jue gla IS alg 4532 € 55 ABA 4h (Sl) 5 ye SU) ula goa i hall AS fay AD Ga ISAT On gall ay 95 eal ray) ipa us SG kaa ally Hug Fi Shay as sells aly aoe gh GS suse Sey A Lg ia iS « gall Cy vy ly Syl BUS y Dall fi nae Ska «5 Sie days ae Ayal) Sly Jbl yo gl) Ayaaly Msg) et 13 Pall o£ pS Meal yall Su asl ge Mga gill) Via plakialy gry lysed Gye Aig iat ley Ga gl gb cid api Ula gi Riygll lbs! 35 way, gavel al eM lal Sighs He (SS antag BL Nba ASLaadl Gacall ess, axe By giSall 4c ‘ght! ont! Tel: 997317113333 Fax: 497317113359 Kingdom of Babvain 0. Box: 11464, Manama email Website waw.nhrabh