Cook Women's Health (Spencer, Indiana) says that hemorrhage following the birth of a child occurs in 1% to 2% of all deliveries and “represents one of the leading causes of childbirth-related maternal mortality.”

But the women's healthcare company, a division of Cook (Bloomington, Indiana), launched in May, now offers the Cook Bakri Postpartum Balloon, which it calls a potentially lifesaving device to aid in the treatment of postpartum bleeding.

“Cook's Bakri Balloon represents a significant advancement in the treatment of postpartum hemorrhage,” said Christina Anné, global leader of Cook Women's Health. “The balloon catheter illustrates one example of our vision of revolutionizing gender-based medicine. Cook Women's Health is committed to improving the quality of life for female patients by offering the highest standard of products that reduce patient recovery times and simplify medical procedures.”

Cook received 510(k) clearance for the product about 18 months ago, and it is currently on the market, Anné told Medical Device Daily. The Saudi Arabian doctor who developed the product and after whom it is named brought the device to Cook, she said, following its successful utilization with many patients. The device was first approved in Europe.

The Bakri Postpartum Balloon is an alternative to the current treatments for postpartum hemorrhage, such as packing the uterus with gauze or a surgical solution, such as with a hysterectomy. Cook says its device not only can stop the bleeding, but do so while preserving fertility.

“We know if you have bandaging or packing on an open wound, and you have to take it out later, you tear the wound open again and it starts bleeding [again],” Anné said.

The device is inserted vaginally into the uterus and a syringe pumps, through a catheter, a sterile liquid into the balloon. The silicone balloon then conforms to the shape of the uterus and provides pressure against the uterus as it is inflated. The balloon works somewhat like putting your finger on a cut to stop the bleeding, she said, noting that it works just about as quickly.

Although the balloon can stay in place for up to 24 hours, Anné said that if a patient still requires the balloon at that point, “then you have a very serious problem.”

Once the hemorrhaging has stopped, the balloon is “easily deflated and removed,” the company said.

Anne said the recognition by a physician that a woman is having abnormal bleeding following childbirth is “pretty easy to decide. Normal bleeding with a delivery is mostly around the baby as it comes out, it's very normal,” she said. “It really stands out as abnormal if the female keeps on bleeding.”

And she said the blood flow is very thick, almost as if you had cut the aorta. “It's a pretty scary situation; it's an emergency situation, and the blood loss is huge,” she said.

Cook formally launched its Women's Health Unit at the American College of Obstetrics and Gynecology (ACOG; Washington) annual meeting (Medical Device Daily, May 9, 2006). The unit, drawing on 40 years of experience at Cook, was formed to specifically focus on women's health concerns and solutions to their unique health problems, such as infertility, chronic pelvic pain, pelvic organ prolapse and incontinence.

At the time, Anné told MDD: “Knowing that, we have actually lined out a roadmap throughout the different life stages of a female patient, basically starting with teens, then the group of 20 to 40, 40 to 60 and 60-plus.”

While in vitro fertilization had been an important area for Cook leading up to the formation of Cook's Women's Health, Anné said the company wanted to go beyond that and “look at a female in the whole.”

That means taking a look at a female's anatomy, not only in a reproductive sense, but different size of their bodies overall and developing products just for women, the company said.