Intrauterine Ball: The next generation of ‘smart’ hormone-free IUDs

The Intrauterine Ball can be both a contraceptive device and a carrier for multiple drugs to the uterus to treat a variety of conditions. Daniela Schardinger, Ocon’s VP marketing and medical affairs, tells FemTech World how the device could decisively change the IUD market. 

The first intrauterine device (IUD) was developed in 1909 by the German physician Richard Richter. After the increase of IUD use in the United States in the late 1950s, physician Howard Tatum determined in the 1960s that a T-shaped copper IUD would work better with the uterus shape.

“60 years ago, the tools and technology gynaecologists used were completely different than what we have today,” says Daniela Schardinger, Ocon’s VP marketing and medical affairs.

Schardinger has been working in women’s health for over 10 years and says that up until recently, the idea that the uterus is a flat organ was widespread. “Within a flat triangle, it made sense to put two dimensional devices,” the VP explains.

“But after learning that the uterus is, in fact, a three-dimensional cavity, we realised that traditional two-dimensional devices with designs that don’t fit well can cause issues such as pain, bleeding, perforation and malposition.”

A three-dimensional, ball-shaped device seems, therefore, a much safer and flexible option that maintains its shape and adjusts to contractions.

The intrauetrine ball (IUB) Ballerine, a copper-based hormone-free intrauterine contraceptive, is Ocon’s first product. The IUB, effective for up to five years, has already been used by over 120,000 women in countries across Europe, South Africa and Israel.

“The idea was essentially to have a better fitting design that fits both women’s anatomy and lifestyle better, minimising side effects,” says Schardinger.

A lack of research along with a lack of funding have led to little to no innovation in the IUD market. Despite an increase in the use of IUDs globally, larger surveillance studies have provided new estimates about the risks of complications such as perforation, especially in postpartum and breastfeeding women, according to the Journal of Contraception.

“We don’t know enough about women’s anatomy and the female body,” Schardinger thinks. “If you look at studies done on IUDs or on most women’s issues, they were all completed more than 30 years ago. There’s not recent research and women, in general, were not included in health research enough.

“But there’s also a lack of tools and a lack of education. I think [the sector] needs a systemic change altogether, to allow women to become drivers of new research that’s so desperately needed.”

However, educational content is still very much limited. Schardinger says that getting the message across is made even harder by social media giants that block a large number of contraception-related posts.

“We don’t talk about these issues enough,” she points out. “That’s also one of the reasons why we see a certain level of distrust towards IUDs. It takes other women sharing their experiences and starting the conversation around intrauterine products. With any innovation, there are early adopters and those who might wait a little bit longer and see.

“What we did was to design the thinnest insertion tube that can minimise the pain of insertion, but also the size of the product itself, so that women who haven’t given birth yet can wear it as well.”

The IUB Ballerine has received positive feedback, with over 80 per cent of users recommending it. “We’re still in early stages,” the VP tells me. “We’re expanding and we’re trying to make it widely available, but it’s not always easy to get through. We’re not available in the UK yet, but we’re working towards reaching that market.”

Ocon is also working on developing and improving its platform. IUB Spherical Endometrial Ablation Device (SEAD) is a pain-free in-office solution in the treatment of abnormal uterine bleeding and heavy menstrual bleeding the Israeli company wants to push forward.

“Procedures currently done in hospital are very, very invasive and painful,” says Daniela Schardinger. “With the SEAD we’ve seen incredible results in our clinical studies. Our aim is to shape the future of women’s health, and bring more options that are less invasive, better fitted for women’s anatomy and adapted to their different life stages.”

IUB SEAD is also a cost effective option that involves substance-derived ablation –  a procedure to remove a thin layer of tissue lining the uterus – technology, moving away from hormones, aggressive procedures and hysterectomies.

Schardinger is excited about the future, adding that a new movement empowers women to start researching, asking questions and demanding solutions.

“Because there are so limited options, I think any new modern technology for women is a win for all of us. We are 85 per cent women in our team at Ocon and we’re all grateful for competition and for companies that bring products in this space,” she adds.

“We’re certainly not afraid of competition. I think every woman needs to have more than one choice and we should all be given more choices and alternatives.”

For more info, visit oconmed.com.