A Pikesville doctor and her colleagues have developed a new breast implant that they say is safer than silicone implants and will make it easier for doctors conducting mammograms to detect breast cancer.
The implant, patented by Dr. Judy Destouet and four colleagues, is filled with fats such as peanut, soybean or sunflower seed oils that, unlike other implants, are translucent and thus give doctors a clearer view of breast tissue.
Dr. Destouet is hoping U.S. Food and Drug Administration approval by year's end will allow the implants to be tested on humans in five cities, including Baltimore, early next year. So far, the new implants only have been tested in cadavers and animals. X-ray tests show the implant has about the same density as normal breast tissue.
"The animals did great," said Dr. Destouet, 45.
If the new implants prove successful, they could have a major impact on the breast implant industry, which has suffered because of recent findings about the health hazards caused by leaking silicone gel implants. Earlier this year, the FDA restricted the use of silicone gel breast implants for purely cosmetic reasons because of the risks involved.
An estimated 1 million U.S. women have silicone implants, 80 percent of them for breast enlargement. The remaining 20 percent were for reconstructive surgery following a mastectomy for breast cancer. Saline implants have not been as popular because they tend to feel watery, and not as natural as the silicone gel implants.
The idea for the new breast implants began in 1986, while Dr. Destouet worked at Washington University's School of Medicine St. Louis. She is now the radiologist in charge of mammographies at Copeland, Hyman and Shackman, physicians with offices in the Baltimore area.
While at Washington University, she and three other physicians used a mobile mammography van to make mammographies more accessible in St. Louis.
They read about 100 mammograms each day and started noticing they were having difficulty accurately reading mammograms of women with silicone implants. Many of the women had cosmetic surgery 20 years ago and were reaching their 40s, when mammograms become especially important.
Dr. Destouet, two other radiologists, a plastic surgeon and a radiation physicist, all from the Washington University medical school, developed their new implant in 1987.
They knew that fat in the body appears as black in an X-ray, and it seemed a logical replacement for a body part that is largely fat.
The doctors approached officials at Dow-Corning, the largest manufacturer of silicone gel implants, to see if the company would be interested in manufacturing the new implant.
"They dropped us like a hot potato," Dr. Destouet said. "It was discouraging. That was a really low ebb because it shattered my illusions. Now we know a lot more about the corporate mentality."
The implants will be manufactured by LipoMatrix, based in Palo Alto, Calif.
Saline implants, currently the only cost-effective option left for women seeking implants for purely cosmetic reasons, do not carry the same risks from leakage as silicone implants. However, both materials are nearly opaque when X-rayed and block anywhere from 20 percent to 80 percent of normal breast tissue. That makes it extremely difficult for doctors to detect breast cancer in its early stages and drastically reduces a mammogram's effectiveness.
"It hides so much of the breast tissue . . . It's just a nightmare," Dr. Destouet said.
The new implant would eliminate dangers from leakage because if it breaks, the body simply absorbs the leaking oil as a food source, Dr. Destouet said. Leaks from saline implants are similarly absorbed. However, leaking silicone has been linked to cancer and various immune disorders.
Mammograms of women who have had breast reconstruction are less affected by gel implants than those of women who simply have had their breasts enlarged, the doctor said. This is because reconstructive implants are generally placed behind chest muscle and usually there is little, if any, remaining breast tissue. However, women still risk the dangers of silicone leakage, which cannot be detected by mammography if the leak is at the back of the implant.
Dr. Alex Munitz, chairman of the department of radiology at Greater Baltimore Medical Center, said there is no question that silicone implants cause problems for physicians analyzing mammograms.
"We're certainly looking forward to seeing these new implants," he said. "It's a very interesting concept."