Originally Published MPMN June 2006

EDITOR'S PAGE

Strong Enough for a Man, but Made for a Woman

Scientists decoding the human genome have discovered that there are 78 genes that differ between men and women. Maybe those genes are responsible for the male inability to ask for directions, or the female affinity for shopping.

That’s up for debate. But it is likely that they play a role in how diseases affect men and women differently.

For example, men have more heart attacks, but women are more apt to die within a year after having one. Migraines are three times more common in women than men. And both lupus and fibromyalgia occur nine times more often in women.

And even when men and women get the same disease, the way they respond to treatment varies. A medical device that works fine for a man may not be appropriate for a woman.

Because of this, FDA’s Office of Women’s Health (OWH) funds research to examine gender differences particularly in the areas of heart disease, obesity, and HIV.

In 2003 and 2004, FDA researchers studied more than 150,000 people with suspected heart disease and found that women had about twice the risk of men for local complications after cardiac catheterization. The study looked at the risks associated with hemostasis devices, which are used after the procedure to prevent continued bleeding of the femoral artery where the catheter is inserted. It may be that the instruments do not work as well for women, causing the higher rate of complications.

Another FDA-sponsored study at Boston University involves the use of blood glucose monitors. They found that different parts of the body can have different glucose values, and they are still researching whether gender might be a factor in the varying levels.

Some medical device manufacturers are realizing that considering gender may go a long way toward creating more-effective products. Many are starting to design devices that are gender-specific.

One such product is the Gender-Solutions high-flex knee, made by Zimmer Inc. (Warsaw, IN). The knee, recently approved by FDA, was designed using three shape differences between men’s and women’s knees.

“Mounting research indicates that a woman’s knee is not simply a smaller version of a man’s knee. The difference involves the bones, ligaments, and tendons in the joints,” says Dr. Aaron G. Rosenberg, an orthopedic surgeon at Rush University Medical Center. He is one of 10 surgeons who helped in the development of the knee.

Cook (Bloomington, IN), another medical device manufacturer, has recently launched its own division that is devoted to women’s health. Christina Anne, head of Cook Women’s Health, says that gender-based medicine is “extremely important” because men and women are “very different” in their healthcare needs.

Maybe men aren’t from Mars, or women from Venus, but we are definitely not the same. Designing gender-specific medical devices will be important in moving healthcare forward.

Susan Shepard, Editor

Copyright ©2006 Medical Product Manufacturing News