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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

Adverse pregnancy outcomes linked to greater social needs in Black and Latina women – study

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Pregnancy complications are linked to greater health-related social needs among Black and Latina women, a study has found.

Adverse pregnancy outcomes include pre-eclampsia, gestational hypertension, gestational diabetes, low birth weight and preterm birth.

These complications are associated with risks of further complications, chronic disease and cardiovascular disease, and disproportionately affect Black and Latina women.

Researchers from Mass General Brigham found that adverse pregnancy outcomes among Black and Latina women were also associated with substantially greater health-related social needs.

These included education, transport, food security, financial strain, employment and social support.

The researchers said integrating assessments of social needs into postpartum care could help improve long-term maternal health and reduce disparities.

Michael C. Honigberg, cardiologist and researcher with the Mass General Brigham Heart and Vascular Institute and senior author, said: “Pregnancy can offer a critical window of engagement for patients and providers.

“Pregnancy complications should be viewed as an opportunity not only for cardiovascular risk prevention but also for screening for and addressing social needs.”

Honigberg and colleagues from Mass General Brigham’s Heart and Vascular Institute and Department of Obstetrics and Gynecology analysed data from the BUSY-BP cohort study.

The study included Black and Latina women recruited from hospitals and health centres affiliated with Mass General Brigham.

Participants completed a screening tool covering their living situation, food, transport, utilities, safety, financial strain, employment, family and community support, education and other needs.

The study included 883 women who had previously been pregnant, including 400 participants, or 45.3 per cent, who had experienced one or more adverse pregnancy outcomes.

Researchers found that the rate of adverse pregnancy outcomes increased as the burden of health-related social needs rose, particularly for needs related to education.

These included help with starting or completing job training, gaining a high school diploma or obtaining a General Educational Development equivalency certificate.

The authors said further research is needed to separate cause and effect and identify interventions based on the findings that could improve health outcomes.

Honigberg said: “Identifying and testing interventions, such as social support programmes that can help women during the postpartum period, will be critical for improving downstream health outcomes for women and babies.”

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Pregnancy

Chemicals in plastics may be linked to high blood pressure during pregnancy

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Phthalates found in plastics and personal care products may be linked to higher blood pressure during pregnancy, a study suggests.

Hypertensive disorders of pregnancy, including pre-eclampsia, are a leading cause of maternal mortality in the US.

Higher blood pressure during pregnancy has also been linked to adverse health outcomes for both mothers and children.

While family history and lifestyle are known risk factors, growing evidence suggests exposure to phthalates may also contribute to raised blood pressure during pregnancy.

Phthalates are chemicals found in plastics, personal care products and hundreds of other consumer goods. Some can interfere with the body’s natural hormones.

Kimberly Parra, of Harvard T.H. Chan School of Public Health, said: “Our study suggests that having higher concentrations of personal care products-associated chemicals, known as phthalates, in the body might contribute to elevated blood pressure in pregnancy.

“While our study does not show that phthalates cause high blood pressure during pregnancy, it suggests that reducing exposure to this class of chemicals by limiting personal care products containing these ingredients, particularly those with fragrance, may be a way to address high blood pressure in pregnancy and improve pregnancy health.”

Researchers measured phthalate exposure and blood pressure in 338 pregnant women from the Environmental Reproductive and Glucose Outcomes Study at three points during pregnancy.

They analysed whether higher levels of the chemicals, individually and in combination, were linked to higher blood pressure or an increased risk of pregnancy-related high blood pressure disorders.

Women with higher urine concentrations of phthalates associated with fragrances and personal care products had higher systolic and diastolic blood pressure, markers of increased risk of hypertensive disorders of pregnancy.

Systolic blood pressure is the pressure in the arteries when the heart beats, while diastolic pressure measures it between beats.

Around 13 per cent of participants developed a pregnancy-related high blood pressure disorder.

Women with higher levels of certain phthalates, particularly those found in personal care products, tended to have higher blood pressure later in pregnancy.

Parra said: “More research is needed to better understand these findings, particularly whether the effects are driven by changes in oestrogen-related pathways. Additional studies should also examine the potential role of other phthalates and their replacement chemicals.”

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Fertility

Higher doses of common fertility drug may increase pregnancy risks

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Higher cumulative doses of common fertility drug clomiphene citrate may increase pregnancy loss risks, according to new research.

Around one in six people experience infertility, with irregular or absent ovulation among the most common causes.

Clomiphene citrate has long been a mainstay of fertility treatment, but Adelaide University research has raised concerns about higher cumulative doses.

The new study found that high doses of clomiphene citrate accumulated over multiple fertility treatment cycles could increase the risk of pregnancy loss.

Lead author associate professor Sheree Boulet said the findings showed a clear dose-response relationship, meaning the risks increased as cumulative exposure rose.

She said: “Women who received higher cumulative doses of clomiphene citrate experienced progressively greater risks of adverse pregnancy outcomes.

“We examined more than 21,000 embryo transfer cycles across four cumulative dose categories and found that increasing the dose did not significantly improve the chance of a live birth.

“Our findings suggest there may be a point where increasing the dose offers little additional benefit while exposing women to greater risk, highlighting the importance of carefully balancing effectiveness with safety when making treatment decisions.”

Supported by the NHMRC and conducted in partnership with Boston University and the Centers for Disease Control and Prevention, researchers analysed 21,004 IVF embryo transfer cycles in the US.

Women receiving cumulative doses of 500mg to 749mg of clomiphene citrate had a 12 per cent higher risk of miscarriage, while those receiving 750mg to 999mg had a 38 per cent higher risk.

Women receiving cumulative doses of 750mg or more were also more than twice as likely to have twins or other multiple births.

Rates of spontaneous abortion, another term for miscarriage, increased as the dose rose.

Researchers also recorded more than a threefold increase in stillbirth at the highest dose, although the finding was not statistically significant because that dose was rare. Larger studies are needed to confirm the association.

The finding is consistent with an earlier Adelaide University study that showed a doubling of neonatal death in pregnancies involving clomiphene citrate. Neonatal death means the death of a baby shortly after birth.

Higher cumulative doses did not improve the chance of a live birth, but did increase twinning, which raises the risk of adverse outcomes for both mother and child.

Clomiphene citrate is one of the world’s most widely prescribed fertility drugs. It has been prescribed to millions of women worldwide since 1967 and remains a recommended first-line treatment for ovulation induction.

The drug is recognised as an essential medicine by the World Health Organization. It works by stimulating the ovaries to release eggs, increasing the chance of pregnancy.

Women who do not respond to lower doses, or who require multiple treatment cycles, may receive progressively higher cumulative doses over time.

The findings build on a series of studies from Adelaide University’s Robinson Research Institute linking clomiphene citrate with increased risks of pregnancy loss, stillbirth, perinatal death and some birth defects.

Experimental studies in mice supported these findings, showing that higher doses reduced successful pregnancies and were associated with pregnancy loss, impaired fetal growth and developmental abnormalities.

Professor Michael Davies, senior researcher and co-author of all the studies, said the latest work builds on more than two decades of Adelaide-led research into the safety of fertility treatments.

He said: “Clomiphene citrate has been used by many women since 1967, but it has never been comprehensively evaluated in large prospective clinical trials.

“Our studies indicate that women respond differently to clomiphene citrate and that increasing cumulative doses may increase the risk of adverse pregnancy outcomes without improving the likelihood of a live birth.

“The findings confirm and extend our previous studies in both human and mouse models which highlight the need to better understand the dose-response relationship and whether more personalised dosing strategies could improve safety.

“Until we can better understand these differences, it remains important that clinicians rigorously follow manufacturer’s safety recommendations and avoid unnecessarily increasing cumulative doses.

“The same questions are now being asked of newer ovulation-inducing medications, so any move away from clomiphene citrate should also be guided by robust evidence rather than assumptions about safety.”

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