NewsTeam 10 Investigates


FDA says La Mesa clinic illegally marketed an unapproved breast cancer detection device

FDA issues warning to La Mesa clinic over unapproved device for breast cancer screening
Posted at 12:16 PM, Feb 27, 2019
and last updated 2019-02-27 15:16:18-05

LA MESA, Calif. (KGTV) - A wellness center in La Mesa is accused of misleading patients by illegally marketing a breast cancer screening device, according to the Food & Drug Administration (FDA).

This week, the FDA issued a formal warning to Total Thermal Imaging Inc. and its president and co-owner, Linda Hayes, for illegally marketing and distributing an unapproved thermography device as a sole screening device for breast cancer and other diseases, according to a press release.

Thermography is heat-sensitive imaging depicted in variations of color.

10News spoke to San Diego's Susan G. Komen breast cancer awareness organization, which says thermography alone is not enough. “It can be used in addition to a mammogram or other screening tool that has been shown effective but there hasn't been any scientific evidence for thermography right now being a standalone tool,” says Lizzie Wittig, Director of Mission Initiatives and Public Policy.

The FDA is demanding a response within 15 working days.

No one at the clinic answered the door. 10News called and sent messages, and got this text reply:

"Total Thermal Imaging Inc. is reviewing the warning letter from the FDA and developing a response. We will work with the agency to ensure our products comply with acceptable regulations."

This isn't the first time that a clinic has gotten a warning letter about thermography. Five other clinics around the country have gotten in trouble with the FDA in recent years.