According to the American Society of Plastic Surgeons, more than 236,800 breast augmentation (enlargement) procedures were performed in 2002. More than 74,000 women had a breast reconstruction (following breast tissue removal for cancer).
To enlarge or reconstruct a breast, surgeons may use a breast implant. The first commonly used device was the silicone gel-filled implant, which has a silicone shell and is filled with silicone gel. Over time, some doctors began questioning the safety of the device. Recent studies show at least 15 percent of silicone breast implants eventually leak or rupture, allowing some of the silicone gel to seep into the body. Some women reported onset of autoimmune problems after implant rupture. In 1992, the Food and Drug Administration placed tight restrictions and limits to the use of silicone implants. In general, silicone implants were available only to breast reconstruction patients willing to participate in clinical studies of the device and patients needing a replacement of a ruptured silicone implant. In December 2003, an advisory panel recommended conditional approval of silicone gel-filled implants. However, early in January, the FDA rejected the recommendations to re-market the device.
Today, the most commonly used breast implants are saline-filled devices, which are made of a silicone shell and filled with a saline solution. But even saline implants carry some risk. The implant's shell can tear or leak, causing the saline solution to leak. The problem can be visibly seen because the deflated breast flattens and shrinks in size. The saline is harmless and absorbed by the body. However, a woman may require another surgery to replace the implant. Capsular contracture occurs when scar tissue that forms around the implant tightens. In most cases, a woman may not notice any changes. However, depending upon the severity of the contracture, the breast may appear firm to abnormally hard, painful and distorted in shape.
Breast implant surgery can have several other risks, like infection, hematoma (collection of blood), changes in nipple or breast sensation, delayed wound healing or extrusion of the implant through the skin. In addition, some women are unhappy with the appearance of the breasts after implant surgery.
Mark Berman, M.D., a cosmetic surgeon from California has developed a device that may reduce some of the potential complications of implant surgery. He has called his invention the "Pocket Protector." The Pocket Protector is a liner for the breast cavity. It’s made of Expanded Polytetrafluoroethylene (ePTFE, the same material used to produce GORE-TEX®). First, a standard incision is made into the breast. Then, using a special device, the Pocket Protector is inserted into the breast tissue pocket. The Protector adheres to the breast tissue, forming a barrier between the tissue and the implant. Next, the implant is placed inside the pocket. The pocket is sealed and the incision is closed.
The material used to produce the Pocket Protector has been used in other medical products and devices for years and is safe and very compatible with the body. By lining the breast tissue there is less risk of scar formation and the pocket stays open, reducing the risk of capsular contracture. If the breast implant would rupture, the contents would still remain inside the Pocket Protector. In addition, if an implant needs to be replaced, surgeons open the pocket and exchange the implant. If for some reason doctors need to remove the Pocket Protector, the lining can be peeled away from the tissue.
Although the material used to make the Pocket Protector is FDA approved, it still needs to be studied and approved to be marketed as a breast implant device. Currently, the Pocket Protector is only in use by its inventor. However, Dr. Berman hopes to soon expand his studies and make the Protector available to other doctors around the country.
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