Australian women are being targeted by the American maker of a gynaecological surgical device with an online campaign which appears to breach advertising laws.

Hologic (slogan: “The Science Of Sure”) is an American medical technology company with a focus on women’s health. Brooke Shields is an ambassador for its SculpSure® body contouring treatment, while MonaLisa Touch® is the name of its post-menopausal vaginal laser therapy. The company also developed the new “ThinPrep” cervical cancer test now used for screening in Australia. It’s considered more effective than previous tests and greatly reduces the frequency that women need to have a pap smear.”

“NovaSure” is one of Hologic’s medical surgical devices. It’s used by gynaecologists to perform endometrial ablations (EA) — the removal of endometrial tissue from the lining of the uterus, to reduce (or eliminate entirely) the bleeding that normally characterises a period. 

EA procedures have been around for decades, but in recent years technological advances have made it an increasingly common treatment for menorrhagia (abnormal uterine bleeding or heavy periods). Medicare statistics show the number of EAs performed in Australia has more than doubled in ten years. 

There are a number of different ways to perform an EA, which is considered a good alternative to hysterectomy in many cases. NovaSure is considered to have a good safety record and high satisfaction rate, but according to the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), “scientific studies have not shown that one method is better than others, either in terms of outcomes or complications”. (The same finding was made by a recent Cochrane review).

Using American-style advertising to create a market 

Hologic is currently trying to reach women in Australia directly through Facebook. Its “Wear White Again” campaign runs sponsored posts targeting women aged 35-55. The posts feature paid video testimonials from women who have had the procedure done (and describe dramatic “life-changing” results), and prompt the viewer to visit a website offering “advice on heavy menstruation and irregular periods”. 

The website, however, is far from independent. “Powered by Hologic”, it describes heavy menstrual bleeding as “incredibly common”, affecting “one in five women” (sometimes clarified as women “aged 35-55”). Where it outlines the range of treatment options for women, NovaSure is the only example given for endometrial ablation. It offers a NovaSure patient leaflet for download, and directs visitors to the “NovaSure Doctor Finder where they can enter their postcode to “find [their] nearest NovaSure doctor”.

Dr Ginni Mansberg, a GP “best known for her TV appearances” as a women’s health expert on Channel 7’s morning shows, appears in a number of videos on the NovaSure site and Facebook page. In one, she offers advice on “How To Talk So Your Doctor Listens”. In another, she discusses the difference between “heavy bleeding and a medical condition”, and favourably describes EA as “a great option”, and “a cure” for 90% of women. Mansberg does not mention NovaSure in any of these clips, and told INQ that her work with Hologic was “to increase awareness around the prevalence and impact of heavy menstrual bleeding”.

The “Wear White Again” campaign is clearly designed to increase NovaSure brand awareness and to encourage women to request Hologic’s patented procedure from their doctors. Professor Beverley Vollenhoven, deputy head of obstetrics and gynaecology at Monash University, told INQ that it was a very “Americanised” approach.

“It’s like doing ‘Google Doctor’ if you like — go to your doctor and talk about a medication or a device that may actually not be suitable for you,” she said.

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The disclaimer

Under Australia’s Therapeutic Goods Advertising Code, ads for therapeutic goods which refer to a “serious” form of a disease, condition, ailment or defect are deemed “restricted representations” and must obtain prior approval. The Therapeutic Goods Administration (TGA) told INQ that menorrhagia was “likely” to be considered a restricted representation, though said it would need to make that determination considering the entire context of the advertisement.

INQ has confirmed the Hologic/NovaSure campaign does not appear on the TGA’s approved ads register.

In addition to the support offered by Mansberg, one of the Facebook testimonials is from a woman identified on-screen as “Donna”, a registered nurse. Although NovaSure isn’t mentioned by name in the video, viewers are again directed to the website where NovaSure is promoted.

The TGA Code prohibits health professionals, including medical practitioners, from endorsing or making testimonials about therapeutic goods in advertising.

Hologic told INQ that “the testimonial from Donna represents her experience as an individual/patient as opposed to her representation of professional organisation”, and that the video included “a disclaimer in line with the TGA advertising code that the video is for general awareness and advises women to talk to their doctor for suitable treatment advice based on their personal situation”. 

The company seems fond of disclaimers. Fine print on the NovaSure Doctor Finder site states: “This information is not intended as a product solicitation or promotion where such activities are prohibited.”

A competitive market

It’s no surprise that Hologic would want to push the boundaries of what’s allowable down under. The global EA device market is heating up — analysts predict it will grow from A$1.4 billion in 2017 to A$2.3 billion by 2026. The Asia-Pacific region is key to this growth, due to increasing availability of EA devices and rising public awareness of the conditions that they are used to treat. Vollenhoven confirmed newer players — such as Librata and Thermablate — are also currently trying to market their products to Australian doctors. 

If Hologic can make NovaSure a synonym for endometrial ablation ahead of their arrival, it will cement its place as the dominant player in this part of the world.

INQ sent a series of questions to Hologic. The company’s response included, in part: “Hologic follows all relevant regulatory policies/codes in any communication with patients, consumers and medical professionals.”

Have you been targeted by any US style pharma advertising? Have any thoughts on the NovaSure campaign? Let us know at [email protected]. Please include your full name for publication.

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