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Do We Need an At-Home ‘Breast Health Familiarity Assistance Tool’?

The “Pink Luminous Breast” allows you to see what’s going on inside.

Photo: Pink Luminous Breast/SilkPro

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About 12 percent of women, or one in eight, will be diagnosed with breast cancer in her lifetime. Approximately 40,920 people will die of the disease this year. These numbers feel truly terrifying. A new device just hit the market to address concerns — or, if you’re feeling less charitable, to play into the fears — people may have about catching signs early.

The somewhat cumbersomely named Pink Luminous Breast, which costs $159, bills itself as a “breast health familiarity tool.” It’s a handheld electronic LED light device that looks a lot like any number of beauty devices that exist to zap body hair or pump microcurrents through your face. (In fact, its parent company, SilkPro, also sells a hair removal device.) This one has a unique function, however, that literally goes more than just skin deep.

Pink Luminous uses transillumination, which is basically a powerful light that can penetrate skin and tissue and illuminate the shape of different breast structures internally. Structures like veins, cysts, and solid masses will show up darker than the surrounding tissue when you press the light to your skin.

Photo: Pink Luminous Breast/SilkPro

Founder Marylin Dans is careful to say that Pink Luminous is not intended to take the place of mammograms or even to be any sort of screening tool. “We don’t want to make claims. It’s not to be a substitute for anything you’re supposed to do. On the contrary, it’s to use in conjunction with, not in lieu of, a mammogram,” she said recently at a lunch in New York City to introduce the device to the press. Dans, who says she had a non-cancerous breast lump at 17, sees it as one more way for women to “become familiar with” their own breasts, beyond just feeling them.

Transillumination is not a new technology. It’s been around since the 1920s and has been used for things like looking into people’s facial sinuses to determine infection, hunting for veins in tiny babies to make it easier to start IVs in the hospital, finding abnormalities in the scrotum, and even looking for tooth fractures. A research paper from 1984 discusses the utility of using it for screening for breast masses. (The upshot: It’s not as accurate as a mammogram.)

The technology is safe, though, including for use by people with implants. The Pink Luminous is approved by the Food and Drug Administration as a Class I device, which just means that it’s not dangerous and doesn’t require extra regulation. (An enema is a Class I device, for example.) Dans says her company is currently performing clinical studies with the device but that the company won’t ultimately share the results with consumers. “If I were to go out and make a claim and say, ‘You can see this size or this size,’ I’m fearful people will not go out and get their mammogram. I would rather say, ‘This is a tool to use.’ We can share the [studies] with our partners and endorsers, but not share with the general public,” Dans says.

The bigger question is what purpose the tool actually serves, beyond potentially bringing WebMD paranoia alive for people. Doctors seem dubious. “My concern is that women will use this test and either not undergo necessary mammography screening because they did not find an abnormality or they find an abnormality that is not cancer and they undergo an unnecessary biopsy,” Dr. Nicole Saphier, the head of breast imaging at the Memorial Sloan Kettering Cancer Center Monmouth, said in an email to Racked. She notes that the current screening standard is yearly mammograms for women over 40, or sooner if there are risk factors.

Dans argues that she’d rather undergo a procedure for a false positive than miss something. “I would rather get a needle biopsy every single year. I want to be a grandmother. I want to live a long life. I embrace a false positive!” she says.

The product’s website gives a bit more of a subtle hard sell, as well as some emotional manipulation. “This is a medical device you can’t afford not to have!” a woman in a commercial for the Pink Luminous says. Copy on the site reads, “We believe Pink Luminous Breast will be an essential screening device for every woman over the age of 25 to incorporate in their health routine.” A banner also reads, “Prevention is key to a healthy & long life. Your family needs you!” Making you feel guilty for not finding your breast cancer early, dying, and leaving your children motherless? Interesting marketing tactic.

A transilluminated breast.
Photo: Pink Luminous Breast/SilkPro

The pricing seems to have gone through some changes. In the commercial, it’s sold in four payments of $49.99. On the site it’s listed at $149. And beginning in August, it will be sold in 100 CVS stores to start, with a list price of $158.99, according to a CVS representative, who also said the chain was attracted to Pink Luminous because “we want to offer our customers an assortment of products that empower them to better their health in ways that are proactive and convenient.”

At the event, Dans said of the price, “I personally wanted it to be $99. Eventually maybe we’ll get there. It’s a matter of volume. Unfortunately, the retailers take so much. The idea is not to make money. The idea is for everybody to be able to afford one.” Dans also says she is starting a foundation to donate devices to third world countries where more high tech screening isn’t available. She’s also working on a solar-powered device for countries where electricity is patchy.

My experience with the device, which the company comped to me, left something to be desired. My mom was diagnosed with breast cancer in her 40s, and as a result of my increased risk, I’ve been getting mammograms and ultrasounds since I was in my 30s. I am well acquainted with my body, so I was actually looking forward to peering inside of it.

After charging the Pink Luminous, you have to go into a dark room, lube up your skin, and press the device to your breast, which lights it up an eerie red color, highlighting veins and whatever else is in there. Unfortunately, all it really did for me was make my breasts glow red, like some sort of sexy robot. I could barely see veins, let alone anything potentially ominous, despite messing around with the light intensity settings and pressure I was applying to my skin. I’ve been told by radiologists that I have dense breasts despite them being tiny, so maybe that’s why.

Dans says, “We are working with a number of reputable oncologists and radiologists who are not yet officially endorsing the product but are testing it in their practice.” For now, I’m skeptical, at least until some more data and user experience comes out to prove me wrong.