Eradicate intrauterine adhesions once and for all
About intrauterine adhesions
Intrauterine adhesions (IUA) or synechiae are fibrous strings at opposing walls of the uterus leading to partial or complete obliteration of the cavity. They may also be referred to as Asherman syndrome. They occur as the consequence of surgery in the uterine cavity and are the major long term complications of operative hysteroscopy.
They are responsible for menstrual disorders, infertility and obstetrical complications such as abnormal placentation. They are associated with miscarriages and retained product of conception with a reported incidence as high as 20% following dilation and curettage for those conditions (1, 2) and up to 45% after myomectomy (3,4).
The recurrence rate after intrauterine adhesiolysis is between 42% and 60% in the case of severe adhesions (5).
Surgical adhesions can be prevented by separating the adjacent injured tissues at the beginning of the scaring phase. While adhesion barrier products exist for abdominal or pelvic surgery like absorbable films or gels, none of them is adequate for intrauterine use, leaving women's uterus unprotected after an intervention.
Intrauterine Adhesion Barrier Film
Womed Leaf is the first and only MECHANICAL BARRIER against adhesions that protects the entire uterine cavity for a week.
At the end of the surgical procedure, Womed Leaf is inserted through the cervix like an IUD and the uterine film is released.
It soaks uterine fluids and grows up to become a film that shields the entire cavity.
By keeping the walls apart, Womed Leaf acts as a mechanical barrier during 1 week.
After a week, the uterine film breaks-up, dissolves and is naturally discharged without any intervention of a healthcare professional.
Intended use: Womed Leaf is intended for the prevention or reduction of new or recurrent intrauterine adhesions formation by creating a temporary mechanical barrier.
Indication: Womed Leaf is indicated for use in all transcervical procedures.
Womed Leaf is a CE marked product.
Not for sales in the US.
At the end of the surgical procedure, Womed Leaf is inserted through the cervix with a flexible inserter, just like an IUD. The uterine film is not sticky and the insertion takes less than 1 minute.
No follow-up required
After a week, the uterine film breaks-up, dissolves and is naturally discharged through the cervix without any intervention of a healthcare professional.
Womed Leaf anti adhesion film self deploys and keeps the uterine walls apart after an intrauterine procedure.
Long lasting effect
Womed Leaf acts as a mechanical barrier during a week, the critical part of the healing phase.
Full cavity protection
Thanks to its swelling ability when in contact with water, Womed Leaf grows to fill the entire uterine cavity.
Safe by design
Product composition and tolerance
Womed Leaf has been designed from well known highly biocompatible compounds: poly(D,L-lactide) acid (PLA) which is commonly used in medical devices like surgical sutures, and poly(ethylene oxide) (PEO) which is a common pharmaceutical excipient. Womed Leaf biocompatibility, tolerance and non toxicity has been thoroughly proven in preclinical studies (6).
A pre-clinical study evaluating possible effects on fertility showed that Womed Leaf had no negative impact on the implantation and development of embryos (6).
Womed Leaf significantly reduces the likelihood of complete IUA formation compared to hyaluronic acid (HA) gel and sham group, demonstrating its efficacy in an animal model (6).
Salazar et al. A comprehensive review of Asherman’s syndrome: causes, symptoms and treatment options Curr Opin Obstet Gynecol 2017, 29:249–256
Hooker et al. Systematic review and meta-analysis of intrauterine adhesions after miscarriage: prevalence, risk factors and long-term reproductive outcome Human Reproduction Update, 2014;20(2)262–278
Taskin et al. Role of endometrial suppression on the frequency of intrauterine adhesions after resectoscopic surgery. The Journal of the American Association of Gynecologic Laparoscopists 2000;7(3):351–4
Guida et al. Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Human Reproduction 2004;19(6):1461-64
Warembourg S et al. Prevention and treatment of intrauterine synechiae : Review of literature. J Gynecol Obstet Biol Reprod. 2015 Apr ; 44 :366-79.
Publication pending (under review)