Unreliable breast cancer screening halted

FDA Consumer, Nov, 1991 by Tom Cramer, Raja Mishra

A Markesan, Wisconsin-based company that used an unapproved method of breast cancer screening, called transillumination, was shut down for public health violations and its equipment seized by U.S. marshals.

In the spring of 1990, Mobile Clinics of Tomorrow Inc. advertised its transillumination services in the local newspapers. An advertisement in The Portage Daily Register promoted the procedure in large block letters as "mammography screening," describing it as a "non x-ray, painless, and rapid breast screening technique" priced at $55. Company representatives then traveled by van to small communities in south-central Wisconsin, offering the transillumination screening.

Transillumination involves shining light in the red and near-infrared spectrum through the breast to illuminate its interior structure. The image of the breast tissue produced can be examined on film or video monitor.

FDA's Obstetrics and Gynecology Devices Advisory Panel recently concluded, however, that transillumination is not an accurate or effective means of breast examination, alone or together with other techniques, for the following reasons:

* Transillumination is not accurate enough to serve as a reliable breast screening method.

* The technique cannot detect tumors smaller than 1 centimeter in diameter. Even larger tumors are more difficult to detect if they are near the chest wall or i n women who have dense breast tissue.

* The method cannot distinguish whether increased vascularity (blood vessels) indicates possible cancer, is usual for certain areas of normal breast structure, or is related to benign breast conditions or internal bleeding that occurs after recent biopsy.

* Transillumination is also an extremely complex process requiring considerable expertise that is not always readily available.

In June 1990, local public health officials in Wisconsin reported Mobile Clinics to the Radiation Protection Section, Division of Health (DOH), Wisconsin Department of Health and Human Services. DOH began an investigation and located the van parked in a shopping center in Portage. Upon questioning, the staff (an x-ray technician and a nurse) provided documentation on the transillumination process and equipment published by the equipment manufacturer, Lintronics International, based in Plantation, Fla.

DOH consulted with the National Cancer Institute, national Centers for Disease Control, and FDA. NCI and CDC both stressed the ineffectiveness of the transillumination process, and FDA said that the device could not be legally marketed as comparable to or as a bustitute for mammography.

On Aug. 6, 1990, Tom Garvin, investigator and x-ray auditor in FDA's Milwaukee resident post (Minneapolis district), inspected Mobile Clinics of Tomorrow.

"After reading the promotional literature obtained during the inspection and subsequent investigations of the companies," he says, "I realized that the process was in no way effective and that there could be possible health fraud involved. At this time, the company [Mobile Clinics] was attempting to sell the transillumination product to local firms in the Milwaukee area for use in 'Worksite Breast Screening Programs' for employees, and I felt actio nwas necessary."

On Dec. 7, 1990, at FDA's request, U.S. marshals seized the van and equipment in MArkesan, Wis. The seizure was based on violations of the federal Food, Drug, and Cosmetic Act, including misbranding the product, distributing inadequate instructions for its use, and failing to notify FDA before marketing.

Garvin, the U.S. marshal, and several local police agencies found the van, with the equipment inside, parked unattended at the corporate president's home. The device and accompanying literature were placed in custody of the U.S. marshal.

Garvin's Aug. 6 inspection of Mobile Clinic revealed that about 60 women in four Wisconsin towns (Appelton, Pardeeville, Princeton, and Portage) had the transillumination procedure. The state's health department prepared releases for print and broadcast media, urging these women to contact the Wisconsin Department of Health and to get proper examinations through the standard procedure, radiographic mammography.

At the time of the seizure, Mobile Clinics of Tomorrow was attempting to sell the device to an x-ray firm in Milwaukee.

Mobile Clinics of Tomorrow consisted of a group of four investors. No legal action was taken against them.

FDA continues to investigate the possible distribution of the company's transillumination devices for similar use in other states.