Reproductive BioMedicine Online (2015) 30, 558
w w w. s c i e n c e d i r e c t . c o m w w w. r b m o n l i n e . c o m
LETTER Adhesion barrier market trends To the Editor I am very interested in adhesion barriers in the field of gynecological operations. I would like to comment on my experience in this field, in the context of the review by Pados et al. (2010) concerning prevention of intraperitoneal adhesions. These authors reviewed adhesion barriers in general. However, barriers manufactured by Korean pharmaceutical companies were not covered. I would thus like to add some further information. Three products made entirely in Korea are currently available. The principal product made in Korea comprises sodium hyaluronate and sodium carboxymethylcellulose (Guardixsol; Hanmi Medicare). In 2011, a combination of hyaluronic acid, methylcellulose, and alginate (Protescal; LG Life Sciences Ltd) became available followed, in 2012, by a combination of hyaluronic acid and hydroxyethylstarch (Medicurtain; Sinpoong Pharmacy). These three products contain principally hyaluronic acid, together with other materials. Pados et al. reviewed hyaluronic acid in the context of solid barrier formation; 14 relevant studies have been published. Thus, Korean pharmaceutical companies have focused principally on the safety and efficacy of hyaluronic acid, which is very gelatinous and thus easy to handle during laparoscopy and exploratory laparotomy, especially hysteroscopy. A further three companies import adhesion barrier materials. The Korean market for adhesion barriers increased rapidly in the past. Twenty billion units of Guardix-sol are sold each year in Korea. Although adhesion barriers are thus popular, certain problems have arisen, and are becoming more severe. First, the Korean market is now decreasing rapidly because, in July 2013, the Korean government placed patients undergoing cesarean sections, and operations on the ovary and uterus (except operations treating cancer and hysteroscopic operations) into a “diagnosis-related group” (DRG). All
operations performed in these patients now attract the same fee. Before this change, patients paid for adhesion barriers, but now do not. The government insists that the fee is adequate to cover adhesion barriers, but clinicians and surgeons disagree. Second, a few data are available from Korean pharmaceutical companies on whether their adhesion barriers aid in recovery from hysteroscopic procedures. A randomized study is required to demonstrate that the barriers prevent uterine adhesion. Prevention of intrauterine adhesion is vital to guard against infertility, dysmenorrhea, and pain. The efficacy of adhesion barriers after intraperitoneal operations on (for example) the ovary and uterus is of major concern. In Korea, IRB-approved clinical trials are required to show that patients undergoing second- look operations benefit from application of adhesion barriers. Presently, the data are inadequate. Thus, the market share of Korean products is static. The products are not approved by the FDA, although some have been approved by the European Community. Both surgeons and patients are familiar with Korean adhesion barriers. We thus thought it worthwhile to add some information on the Korean experience to the review of Pados et al., to form a more comprehensive picture.
Reference Pados, G., Venetis, C.A., Almaloglou, K., Tarlatzis, B., 2010. Prevention of intra-peritoneal adhesions in gynaecological surgery: theory and evidence. Reprod. Biomed. Online 21, 290–303.
Tae-Hee Kim, Hae-Hyeog Lee Department of Obstetrics and Gynecology, Soonchunhyang University College of Medicine, Bucheon 420-767, Republic of Korea E-mail address: [email protected]
http://dx.doi.org/10.1016/j.rbmo.2015.01.007 1472-6483/© 2015 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.
w w w. s c i e n c e d i r e c t . c o m w w w. r b m o n l i n e . c o m
LETTER Adhesion barrier market trends To the Editor I am very interested in adhesion barriers in the field of gynecological operations. I would like to comment on my experience in this field, in the context of the review by Pados et al. (2010) concerning prevention of intraperitoneal adhesions. These authors reviewed adhesion barriers in general. However, barriers manufactured by Korean pharmaceutical companies were not covered. I would thus like to add some further information. Three products made entirely in Korea are currently available. The principal product made in Korea comprises sodium hyaluronate and sodium carboxymethylcellulose (Guardixsol; Hanmi Medicare). In 2011, a combination of hyaluronic acid, methylcellulose, and alginate (Protescal; LG Life Sciences Ltd) became available followed, in 2012, by a combination of hyaluronic acid and hydroxyethylstarch (Medicurtain; Sinpoong Pharmacy). These three products contain principally hyaluronic acid, together with other materials. Pados et al. reviewed hyaluronic acid in the context of solid barrier formation; 14 relevant studies have been published. Thus, Korean pharmaceutical companies have focused principally on the safety and efficacy of hyaluronic acid, which is very gelatinous and thus easy to handle during laparoscopy and exploratory laparotomy, especially hysteroscopy. A further three companies import adhesion barrier materials. The Korean market for adhesion barriers increased rapidly in the past. Twenty billion units of Guardix-sol are sold each year in Korea. Although adhesion barriers are thus popular, certain problems have arisen, and are becoming more severe. First, the Korean market is now decreasing rapidly because, in July 2013, the Korean government placed patients undergoing cesarean sections, and operations on the ovary and uterus (except operations treating cancer and hysteroscopic operations) into a “diagnosis-related group” (DRG). All
operations performed in these patients now attract the same fee. Before this change, patients paid for adhesion barriers, but now do not. The government insists that the fee is adequate to cover adhesion barriers, but clinicians and surgeons disagree. Second, a few data are available from Korean pharmaceutical companies on whether their adhesion barriers aid in recovery from hysteroscopic procedures. A randomized study is required to demonstrate that the barriers prevent uterine adhesion. Prevention of intrauterine adhesion is vital to guard against infertility, dysmenorrhea, and pain. The efficacy of adhesion barriers after intraperitoneal operations on (for example) the ovary and uterus is of major concern. In Korea, IRB-approved clinical trials are required to show that patients undergoing second- look operations benefit from application of adhesion barriers. Presently, the data are inadequate. Thus, the market share of Korean products is static. The products are not approved by the FDA, although some have been approved by the European Community. Both surgeons and patients are familiar with Korean adhesion barriers. We thus thought it worthwhile to add some information on the Korean experience to the review of Pados et al., to form a more comprehensive picture.
Reference Pados, G., Venetis, C.A., Almaloglou, K., Tarlatzis, B., 2010. Prevention of intra-peritoneal adhesions in gynaecological surgery: theory and evidence. Reprod. Biomed. Online 21, 290–303.
Tae-Hee Kim, Hae-Hyeog Lee Department of Obstetrics and Gynecology, Soonchunhyang University College of Medicine, Bucheon 420-767, Republic of Korea E-mail address: [email protected]
http://dx.doi.org/10.1016/j.rbmo.2015.01.007 1472-6483/© 2015 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.
