Albuquerque doctor is the first to use new uterine cancer detection tool

Uterine cancer comes with an early-warning system: abnormal uterine bleeding. But abnormal bleeding can also mean a host of other, sometimes easily addressed, issues. So how do you know what’s wrong?

One way is to look inside the uterus, and a new FDA-approved medical device developed by Luminelle aims to make hysteroscopy — examining the inside of the uterus with a camera — easier, and help doctors get more conclusive biopsy results.

“There are about 6 million blind endometrial biopsies done every year,” said Albuquerque gynecologist Dr. Amy Garcia. “Even if a fraction of those were utilizing a visualization process, we could really change outcomes for patients, I’m convinced. I know it to be true. I’m hopeful that this device does exactly that.”

Garcia has offered her opinion on medical devices for over 15 years, a role she loves because it’s an opportunity to work with engineers and give clinical feedback. Garcia is from Albuquerque and started her own medical practice in 2005.

“Most of my career was not doing regular gynecology, the preventative stuff and regular screenings, but surgery and I had a very busy practice in the operating room doing laparoscopy and hysteroscopic. I started really, really early, before there were any kind of insurance codes and insurance reimbursement, doing hysteroscopy in my office.”

Garcia has spent the last two years helping develop Luminelle Bx. She’s on the company’s medical advisory board and is conducting a clinical trial at her practice with the device.

The new tool is designed to make it easier for gynecologists to see what could be causing abnormal uterine bleeding, with its 3-millimeter camera. The device is simultaneously meant to make getting good samples easier if a biopsy is needed, using the same kind of suction technology that blind-biopsy tools already use.

Typically, a uterus is 3-inches long and 2-inches across, and looking inside of one is like trying to look in a triangle-shaped room where the ceiling is collapsed on the floor.

An ultrasound can offer a grayscale image that can point to issues, but for really good data, gynecologists can look inside a uterus with a camera, inserted into the vaginal canal and past the cervix, or inserted surgically.

Doing hysteroscopy in an office setting can be more challenging, because the patient is awake and needs to be made comfortable — which might mean some ibuprofen or local anesthetic — and the tools are smaller than those used for a similar procedure on an operating table.

“It’s estimated only 10 to 15% of gynecologists are doing any hysteroscopy in the office, so not even just using a camera to take a look, and there is a slew of possible instruments to use that really have evolved to refine the process,” she said.

Gynecologists have good tools that have been around since the 1970s, Garcia said, but those tools have been refined and improved upon. Cameras, in particular, have gotten smaller and easier to use.

“The basic concept and physics of these devices has never changed, but we’ve just gotten better and better at creating devices that are going to improve the functionality and ultimately how well we can use them comfortably with patients.”

Some of the instruments available are tiny, tiny cameras with tiny scissors or graspers — 1.5 millimeter tools, which can take more surgical skill to use. The new Luminelle instrument is meant to be easier to operate by taking samples via suction.

The device is also meant to allow more conclusive biopsy results than a blind biopsy. A sample taken via blind biopsy that comes back negative is not necessarily conclusive because a cancerous tumor could be in one small spot in the uterus causing the bleeding.

“The problem is if it comes back negative, you haven’t answered the question about why she is bleeding ... You can’t say that there is or isn’t cancer and you can’t say that there is or isn’t something that’s benign causing the bleeding that needs to be addressed,” Garcia said. “The majority of bleeding for women is benign, but you have to answer the question, or you can’t intervene, and she’s coming to you because probably that bleeding has affected her quality of life.”

Garcia hopes the new medical device will help gynecologists more effectively diagnose abnormal uterine bleeding, and she wants women, especially post-menopausal patients, to take abnormal bleeding seriously. Usually the cause is not cancer, but whatever the reason, the bleeding can be addressed.

“Women are just so strong, and we receive a lot of messages in our culture to not complain, but by our new definitions, abnormal uterine bleeding, literally we call it abnormal if it affects the patient’s life. End of story. It doesn’t have to be that you are anemic because you bleed so heavy that you’ve got half your blood volume. It really is, ‘Hey, I’m a woman, and I bleed, and it affects the quality of my life.’”