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

Intrauterine drug-delivery technology aims to improve women’s health and quality of life with ball-shaped device

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Ocon's IUB Ballerine device

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.

Pregnancy

Women with multiple health conditions face higher pregnancy risks, study shows

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Women entering pregnancy with multiple long-term health conditions face higher risks of miscarriage and other complications, a UK study found.

Those with two or more pre-existing physical or mental health conditions had a 20 per cent higher risk of miscarriage than women with no long-term conditions.

They also had more than twice the risk of venous thromboembolism and around four times the risk of antenatal anxiety and depression.

The UK-wide research team analysed 2,225,701 pregnancies and birth events recorded between 2000 and 2022 across five datasets covering England, Scotland, Wales and Northern Ireland.

Women with multiple long-term conditions had a 69 per cent higher risk of nausea and vomiting during pregnancy and a 42 per cent higher risk of pre-eclampsia.

The women also had a 32 per cent higher risk of placental abruption and a 26 per cent higher risk of gestational diabetes.

Risks rose as the number of existing conditions increased.

Among women with three or more long-term conditions, the risk of venous thromboembolism was more than three-and-a-half times that of women with no long-term conditions.

Researchers said the findings had implications for maternity services, where care pathways are largely centred on individual conditions and may not adequately meet the needs of women with multiple long-term conditions.

Dr Kelly-Ann Eastwood, joint senior author and honorary lecturer at Queen’s University Belfast and consultant obstetrician at St Michael’s Hospital, Bristol NHS Foundation Trust, said the results “help define” the urgent clinical challenges facing women entering pregnancy with multiple long-term conditions and the clinicians caring for them across the UK.

“These findings highlight the pressing need to restructure existing maternity services to improve antenatal outcomes,” she added.

The authors cautioned that the study was observational and relied on routinely collected health records, meaning some conditions and outcomes may have been under-recorded, while residual confounding could not be excluded.

The researchers plan to examine birth and child outcomes and identify which combinations of long-term conditions carry the greatest risk.

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Pregnancy

Ultrasound Direct extends Trice Imaging partnership

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Ultrasound Direct has extended its Trice Imaging partnership for three years, adding a reporting tool across its 70-clinic UK network.

The private ultrasound provider will continue using the Tricefy platform for secure image storage and patient engagement, alongside TriceIQ for efficiency and productivity analytics.

It will also introduce Trice Workspace Reporting across its network. The companies say the tool will help standardise ultrasound reporting templates and workflows and reduce variation between clinics.

Ultrasound Direct carries out an estimated 120,000 patient scans each year across services including pregnancy, fertility, women’s health, men’s health and other diagnostic pathways.

Its network uses a large pool of sonographers working across different ultrasound systems and serves referral routes including self-referring patients, GPs and commercial partners.

Mike Steward, founding director at Ultrasound Direct, said: “Having worked with Trice Imaging since 2018, we first partnered to replace manual methods of providing scan images to expectant parents with Trice’s secure electronic image-sharing platform. Today, every study performed across the Ultrasound Direct Network is recorded and stored on Tricefy, while our clinical services have expanded considerably beyond pregnancy into fertility, women’s health, men’s health and other diagnostic pathways.”

He added: “To continue futureproofing our image management strategy across a network of 70 clinics, a large team of sonographers, varying ultrasound systems and a growing number of referral partners with different needs, we decided to extend with Trice Imaging. This includes the introduction of the new Trice Workspace Reporting module to help us scale and standardise our ultrasound reporting templates and workflow, reducing variability between clinics.”

The partnership began in 2018, initially focusing on replacing manual methods of sharing pregnancy scan images with expectant parents.

Johanna Wollert Melin, founder and chief executive of Trice Imaging Europe, said: “Ultrasound Direct has been a valued partner in the UK for 8 years.”

She added: “At the heart of the relationship is a willingness to explore new ideas, test new tools and the spirit to solve real challenges across a large and complex clinical network.”

Mark A. Samii, chief revenue officer at Trice Imaging, said: “We are delighted to retain and extend our relationship with Ultrasound Direct.”

He added: “The addition of Trice Workspace Reporting addresses a challenge we hear from multi-site providers globally – keeping reporting quality consistent across many users, systems, referral or payer relationships.”

Steward said Ultrasound Direct continues to see growing demand for private diagnostics alongside NHS care from self-referring patients and an increasingly diverse range of professional and commercial referral partners.

He added: “As that development continues, scalable digital infrastructure becomes increasingly important. Our focus is on ensuring that a growing national network can support consistent clinical workflows, different referral pathways and the technology requirements of the future, while continuing to provide patients with accessible diagnostic services.”

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Pregnancy

Paracetamol use may impact future fertility, studies suggest

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Paracetamol use in pregnancy was not linked to autism or ADHD, while separate research found reproductive differences in girls exposed before birth.

One study analysed health records from more than 120,000 children and found no increased risk of autism following prenatal paracetamol exposure.

A separate analysis of nearly 100,000 children also found no increased risk of ADHD among those born to mothers who used the painkiller during pregnancy.

Researchers from the Hong Kong Hospital Authority examined electronic health records covering pregnancies between January 2001 and December 2023.

The autism analysis included 124,333 children, who were nine years old on average and split almost evenly between males and females. There were 3,445 autism diagnoses, representing 2.8 per cent of the group.

The ADHD analysis involved 97,285 children, who were seven years old on average and also split evenly between males and females. There were 5,168 ADHD diagnoses, representing 5.3 per cent.

Women prescribed paracetamol during pregnancy were more likely to be older and have pre-existing conditions including psychiatric disorders, as well as reasons for taking the drug such as infection, fever or chronic pain.

No association was found between prenatal paracetamol exposure and either autism or ADHD.

The findings did not differ according to the trimester in which paracetamol was taken or whether use was intermittent or daily. Advanced maternal age, defined as pregnancy in women over 35, did not alter the findings.

The researchers wrote: “Paracetamol remains a safe and essential analgesic [pain reliever] and antipyretic [fever reducer] during pregnancy, whereas alternatives, such as NSAIDs and opioids carry well-documented risks.

“Unwarranted reluctance to use paracetamol could lead to undertreatment of pain and fever, or the use of more harmful alternatives, both posing risks to the pregnancy and developing fetus.”

The authors said women should assess paracetamol use with guidance from their doctor.

A separate study involving 685 pregnant women without pre-existing conditions and 302 infant daughters found associations between prenatal paracetamol exposure and differences in reproductive organs and hormone levels.

Researchers from Copenhagen University Hospital enrolled the women during their first trimester and assessed them during the first trimester, third trimester and again when their babies were three months old.

At around three months, infants experience a temporary rise in reproductive hormones sometimes called mini-puberty.

Pregnant participants completed questionnaires every two weeks about their use of pain medicines including paracetamol. Infant girls underwent ultrasound scans of their reproductive organs and blood tests to measure hormone levels.

Researchers also examined a separate group of 1,210 girls followed from infancy to adolescence whose mothers reported paracetamol use during the third trimester.

Three-month-old girls exposed to paracetamol before birth had an average 40 per cent smaller ovarian volume, 13 per cent smaller uterine volume and 23 per cent fewer ovarian follicles.

Girls exposed during the first trimester also had lower levels of Anti-Müllerian hormone, a marker of ovarian function.

Among the older girls, those exposed before birth were more likely to have smaller uteruses at puberty and smaller ovaries during their teenage years.

Dr Margit Bistrup Fischer, lead study author and postdoctoral researcher in the Department of Growth and Reproduction at Rigshospitalet hospital in Denmark, said: “Animal studies have demonstrated that impaired formation of ovarian follicles can lead to reduced fertility and earlier reproductive aging.

“Whether the differences observed in our study have implications for fertility and age at menopause in humans remains unknown and will require long-term follow-up of the girls in our cohort.”

She cautioned that women who had used paracetamol during pregnancy “should not be alarmed by our findings”, as the study found associations rather than direct causation and outcomes for individual women and children are unclear.

“Importantly, our study does not evaluate whether [acetaminophen] causes reproductive problems, nor does it provide evidence that prenatal exposure affects future fertility or age at menopause,” she said.

“Although we observed similar associations in an independent cohort, long-term follow-up is needed to determine whether these early-life differences have any clinical significance later in life.”

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