Research Indicates 94 Percent Success Rate for Pelvic Organ Repair Utilizing Surgisis(R) ES Biomaterial.

SPENCER, Ind. -- Estimates show that approximately 50 percent of all women who have given birth will eventually suffer from pelvic organ prolapse, a condition caused by the weakening of the tissue in a woman's pelvic region, causing a negative impact on a woman's quality of life.

Research findings presented earlier this month at the International Urogynecological Association (IUGA) annual scientific meeting in Athens show that Surgisis ES (www.cookwomenshealth.com), a biomaterial made from Small Intestinal Submucosa (SIS), was used to successfully repair prolapse in 94 percent of the patients studied.

Research conducted by Dr. Richard Reid at The Hunter New England Health Service in Australia, shows that at 12 months following the repair surgery, patients experienced a statistically significant reduction in all pre-existent symptoms including pelvic discomfort, backache, urinary incontinence and voiding difficulty. Dr Reid also found that the Surgisis biomaterial was better suited as a repair material than most synthetic and cross-linked grafts, due to its flexibility and ability to support the body's complex healing processes.

The Surgisis ES Research

Globally sold by Cook Women's Health, Surgisis ES Soft-Tissue Graft, is a unique biomaterial comprised of collagen, proteins and other bio molecules. Once implanted in the patient, the graft serves as a 'scaffold' to encourage and support the re-growth of new, strong, organized and totally vascularised healthy tissue.

Dr Reid's research shows that the Surgisis graft not only eliminates the patient's immediate symptoms but may also help patients avoid long-term complications often associated with other types of graft materials. Patients treated with Surgisis grafts are not likely to suffer from encapsulation or erosion of the graft material. These problematic results can occur as a reaction to grafts made from synthetic mesh or chemically treated (cross-linked) natural materials.

Dr. Reid conducted three studies on a total of 98 women following surgery for three forms of pelvic organ prolapse - recto-enterocele, vaginal paravaginal repair and vaginal paravaginal repair for severe cysto-urethrocele. The studies investigated the level of repair reliability at one or two years following the operations and considered other factors, including:

-- The recurrence of posterior or apical segment prolapse

-- The success in controlling systems such as pelvic discomfort, vaginal wall bulging, rectal emptying difficulty and pain during sexual intercourse 

-- The degree of post-operative inflammation and scarring

-- Significant complications

Research Findings

-- In 94% of cases, the prolapse operations were a success at one year follow-up

-- There was a statistically significant reduction in all pre-existent symptoms

-- Using Surgisis ES simplified what may be a difficult repair operation

-- In the pre-operative, intra-operative and post-operative phases of surgery, complications were minimal

In evaluating the safety and efficacy of vaginal repair using Surgisis ES, Dr. Reid concluded: "Based on anatomic and functional outcomes measures, 94.6 percent of the patients studied experienced outright or qualified success...No graft related morbidity has been seen. Looking at short term follow-up, this cohort of patients experienced a statistically significant reduction in pre-existent symptoms."

"My research also found that using Surgisis ES shortened and simplified what is traditionally a difficult operation. Any product that can improve the tensile strength of the connective tissue laid down after pelvic surgery may have profound implications for the durability of the repair. Incorporating a bio-absorbable protein scaffold such as Surgisis ES can create strong tissue support and increase the success of repair in the short - medium term."

Christina Anne, Global Leader of Cook Women's Health, comments: "As the female population ages, the number of women with pelvic organ prolapse continues to rise. More than 50 percent of women over age 55 and older will suffer one more of the problems caused by pelvic floor dysfunction. One in every nine women will undergo surgery for a pelvic floor disorder. (1) Cook is committed to improving the quality of life for female patients by offering the highest standard of products such as Surgisis ES that reduce patient recovery times and simplify medical procedures."

Pelvic Organ Prolapse

Pelvic Organ Prolapse (POP) usually occurs in women who have had more than one vaginal birth - either soon after the births or in old age. With pelvic floor muscles weakened following multiple or heavy births, organs such as the uterus 'fall down' into the vagina, causing a range of symptoms from discomfort or pain to incontinence. It is estimated that half of all women who have had vaginal births lose pelvic floor support, resulting in some form of prolapse - and that of these women 10 to 20% seek medical care(2).

About Cook

Cook Women's Health is focused on bringing patient-centred innovations to market, developed specially for the particular health needs of women. Cook Women's Health continues to uniquely address prevalent issues in women's health globally including infertility, high-risk obstetrics, chronic pelvic pain, pelvic organ prolapse and stress urinary incontinence.

With international headquarters in Bloomington, Indiana, COOK(R) (www.cookmedical.com), the world's largest privately held medical device manufacturer, is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for radiology, cardiology, urology, critical care medicine, general surgery, assisted reproduction, gynaecology and obstetrics, endovascular medicine, gastroenterology and endoscopy.

(1)www.surgery.usc.edu/divisions/cr/pelvic floordisorders, University of Southern California,

(2)Beck RP. Pelvic relaxation prolapse. In: Kase NG, Weingold AB, eds. Principles and practice of clinical gynaecology. New York: John Wiley, 1983:677-685.