Undergoing surgery to correct pelvic organ prolapse is always difficult, and according to Cook Women’s Health (Spencer, Indiana), a division of Cook Medical (Bloomington, Indiana), some current tissue repair methods may not provide a lasting solution.

Thus, patients may require multiple procedures to remove and replace the mesh or graft and subsequent scar tissue to regain the positive effects of the surgery, the company said.

With what it says is a more permanent solution, Cook Women’s Health this week introduced a product designed to help the pelvic floor repair itself and do so naturally.

The Surgisis Biodesign is not just a new type of standard mesh or graft, the company said, but a whole different category in the evolution of tissue repair.

The product combines attributes of synthetic mesh and biologic grafts, while offering a specifically designed solution for the challenges of anterior and posterior pelvic floor repair, including resistance to infection, encapsulation and erosion into surrounding tissue.

Neal Bridgett, director of business development for Cook Women’s Health, told Medical Device Daily that the Surgisis is a second-generation graft material that is “truly bioactive, as opposed to a lot of the previously available materials that are processed in a way that makes them inert.”

According to Cook, the Surgisis Biodesign communicates with the patient’s body, signaling surrounding cells to grow across the scaffold, allowing the body to restore itself.

The result, the company says, is “completely remodeled tissue that is strong and flexible.”

Pelvic organ prolapse is a prevalent pelvic disorder affecting more than 50% of women over age 55 and one out of three women who have given birth vaginally. The disorder may lead to urinary and rectal incontinence, resulting in physical and emotional problems, which can have a severe negative impact on all aspects of a woman’s life, Cook said.

Jeanny Chung, a product manager at Cook Women’s Health, told MDD that there are four key attributes of the Surgisis Biodesign: resistance to infection, complete remolding, long-term strength, and the ability to signal the body to send surrounding cells to grow across the scaffold.

“Those are the four benefits that we discussed with the physicians,” Chung said.

The product also is made specifically for the anatomical shape of the pelvic floor, she said.

Bridgett said the product has been well received so far by physicians who perform pelvic floor repairs.

“I think the thing that separates our product from the majority of products on the market is that ours really does work to remodel the patient’s tissue,” Bridgett said.

Because Surgisis Biodesign helps the pelvic floor remodel itself naturally, the patient’s restored tissue functions normally within the body, the company said. Once the healing process is complete, Surgisis Biodesign is undetectable and provides a permanent repair, reducing the need for multiple surgeries, according to the company.

“The symptoms associated with pelvic organ prolapse have many negative effects on a patient’s quality of life. Therefore, it is imperative that they receive effective and lasting treatment,” said Christina Ann , global business unit leader of Cook Women’s Health. “The new, pre-cut anatomical shapes save surgeons time in the operating room, and improve the accuracy and consistency of cutting and placing the graft. These benefits will certainly improve patient outcomes.”

The unit addresses various areas of women’s health issues, including pelvic floor repair, high-risk obstetrics, assisted reproductive technology and gynecological imaging.

Cook launched its Women’s Health unit in May of last year (Medical Device Daily, May 9, 2006), and it grew 30% in its first year (MDD, May 11, 2007).