The Edwards Agency


One woman's nightmare has a strong message

Malee Shay

Malee Shay says consumers need more information and second opinions before undergoing serious medical procedures.
Photo by Deborah Stone.

informed healthcare by Deborah Stone
A Bothell woman who says she had blind faith in the medical profession and complete trust in its practitioners is on a campaign to change what she calls these complacent and passive attitudes. Malee Shay has been telling her story in an effort to create informed consumers who are willing to act assertively with their own health care.
   Shay's experience began with a routine mammogram at a Bellevue clinic in October 1993. A healthy woman in her mid-forties, she was told her X-rays showed something suspicious in her left breast. She was scheduled to return for magnified, close-up views of the area in question.
   Her second visit involved over two hours of X-rays totaling 25-30 readings, Shay says. The results indicated an irregularity, and she was informed that she needed a biopsy to determine whether cancer was present. Shay says that although she spoke with the radiologist briefly by phone at her own insistence, she never received a thorough consultation or met the doctor until the day of the procedure. No other options were presented to her other than the biopsy.
   A week later Shay returned to the same clinic to have what is termed a "stereotactic core biopsy," a relatively new procedure which involves insertion of a large needle at high speed into an isolated area of the breast. The needle acts as a drill, which removes several cores of tissue for examination. Shay had 10 samples removed from her breast in what she said was an "excruciatingly painful process." The biopsy results took six days and, to her immense relief, she learned she did not have breast cancer, she said.
   But while recovering from the biopsy, which she said produced trauma and severe bruising, Shay became suspicious of the care she had received. Although she had considered herself a consumer advocate and a woman who makes informed decisions, she said she realized that in this case, because of her emotional state and the feeling of urgency in the situation, as well as the doctor's assurances and reputation of the clinic, she had agreed to the decisions made without getting a second opinion.
   But she subsequently learned several things: First, it is standard to have from one to three magnified views, not 25 to 30, which provided a heavy dose of radiation. She said she had also been told there would be no pain because the area would be numbed sufficiently, only a few samples would be taken, and she would be "pampered."
   During the biopsy, however, the area was numbed initially, but when the first core was taken, she felt the pain of the needle and the extraction, she said. She complained loudly about the pain, she said, but the two doctors present did not respond. Each subsequent sample taken produced more pain, Shay said. Valium was given to her every half-hour, with no effect on the pain. Her vital signs were never taken, she said, even though she was being tranquilized.
   Shay says she learned later that when done by a properly skilled professional, the stereotactic core biopsy takes from 20 minutes to one hour and involves little discomfort. And there were other parts of the procedure she says are considered poor medical practice.
   "I now distrusted the process, which meant that I also distrusted the results," said Shay, "and I sought a second opinion from a highly respected expert in the field."
   In March of 1994, after fighting with the clinic to release her records and X-rays, she was told by another physician that she hadn't needed the biopsy at all. In addition, her X-rays had been misread: Her right breast, in addition to the left one, had a very distinctive suspicious spot which had not been checked. After this scare, she was relieved to find it, too, was cancer-free. The second physician also informed Shay that she should have been given options after the magnified readings, such as a "wait and see period."
   Shay also questioned the explanation of insurance benefits, after a representative at the clinic told her it was an experimental procedure and that she wouldn't be billed, as she was one of the first 100 patients to use this type of machine. Shay contends she had been used as a "guinea pig" without informed consent.
   During her personal investigation, Shay interviewed more than 35 radiologists, doctors, technicians, and other experts regarding informed consent and what should happen during a surgical procedure. She sent reports to the American College of Radiology, the FDA, and King County Medical Society and filed a formal appeal with the Washington State Quality Medical Insurance Commission. She has also just recently filed a lawsuit against the clinic.
   Recently, the FDA invited her to speak at a meeting in Washington, D.C. on regulating stereotactic biopsies. She related her experiences and her concerns and was told her testimony had a powerful impact on the experts gathered there. The media has interviewed her, as well. She says she will continue this awareness campaign to help protect consumers and force regulatory agencies to govern effectively.
   "I'm not opposed to the stereotactic biopsy procedure or equipment," Shay said. "I just want some regulations and standards put into place regarding the proper use of the equipment and the requirements for who will operate it. Informed consent should be required for all new procedures and patients should know if they are going to be part of a learning curve."
   Shay urged women to take responsibility for their health care and insist on obtaining second and third opinions, as well as examining all options. "Be aware of what can go wrong, the pitfalls, even if you think you're an informed consumer," she said. "Ask questions, demand answers. I learned this the hard way."