History & development of the diaphragm

The history and development of the diaphragm: from Mensinga to the Caya® Contoured diaphragm.

Starting point: birth control before modern contraceptives

Before modern contraceptives were developed, women often experienced ten to fifteen pregnancies over the course of their lives. For many families, each additional birth represented a considerable economic and social burden. The need for effective, woman-friendly methods of contraception was correspondingly high in society.

At the same time, birth control was prohibited by law. A social conflict arose between the practical need for contraception and the legal restrictions. It was against this backdrop that the development of the diaphragm began. 

1882 – Development of the first diaphragm

In 1882, the German gynaecologist Dr Wilhelm Peter Johannes Mensinga developed the first vaginal diaphragm in Flensburg (Germany). The aim was to alleviate the so-called ‘marital distress’, a social problem arising from frequent pregnancies and the associated burdens on families.

As the youngest of nine siblings, Mensinga was familiar with the realities of life in large families. He saw it as his medical duty to develop practical solutions to the health and social challenges faced by women. 

The product he developed was known as the Mensinga pessary. It represented an early form of mechanical contraceptive that covered the cervix and was thus used for contraception.

His personal background also played a role: Dr Mensinga’s wife had died giving birth to their third child. An event that further shaped his commitment to the development of the diaphragm.

Early 20th century – Establishment as a barrier method

At the start of the 20th century, the diaphragm established itself as a key female barrier method of contraception alongside the condom.
The diaphragm, known as the Mensinga pessary, provided millions of women with safe, hormone-free contraception – particularly in the USA and the Netherlands – and remained widely used until the 1960s. 

At the same time, other contraceptives were developed: latex condoms had been available since 1913, contraceptive suppositories were introduced in the 1920s, and the first gels for use in combination with diaphragms came into use.

1960s – Decline due to hormonal contraceptives

With the gradual introduction of hormonal contraceptives in the 1960s, particularly the contraceptive pill, the diaphragm lost its significance. 

However, the basic principle of the diaphragm remained unchanged: mechanical contraception by covering the cervix in combination with a diaphragm gel. As a contraceptive used only when needed, it remained relevant. 

1996 – Start of the redevelopment (SILCS project)

In the mid-1990s, a fundamental redesign of the diaphragm method began.

The international organisation PATH (Programme for Appropriate Technology in Health), based in Seattle, initiated the SILCS (Single Size Barrier Device) research project. The development approach pursued the concept of a single size to simplify the use of the diaphragm worldwide.

The aim was to develop a modern, hormone-free contraceptive for women, particularly for countries with limited access to healthcare.

Funding was provided by the US development organisation USAID (75%) and the Bill & Melinda Gates Foundation (25%). It was therefore a government-funded research project in the field of contraception.

1996–2006 – Research and clinical trials

Over a period of ten years, several independent research groups developed a new diaphragm concept as part of the SILCS project. The studies were conducted without any commercial exploitation interests.

Among other things, the following were investigated:

• the possibility of a one-size-fits-most design through modified shaping
• the secure position of the diaphragm in the upper vaginal vault (documented for the first time using MRI scans)
• Widespread acceptance and use in different cultural contexts
• use without the need for individual medical sizing
• Comprehensibility of the instructions for use
• Safety and practical handling

New design and defined requirements

Under the development name SILCS, a diaphragm was created with clearly defined requirements:

• easy to use
• reliable in contraception and handling
• biocompatible materials, no latex, no metal ring in the rim
• reversible if planning a pregnancy
• hormone-free and hypoallergenic
• cost-effective (reusable)
• eco-friendly (not a single-use product, no hormonal residues, e.g. in water)
• Can be used regardless of cultural background

The result was an anatomically shaped diaphragm made from a flexible polymer ring and medically tested silicone.

2006 – Pilot production

In 2006, a small batch of the newly developed diaphragm was manufactured for the first time in Wisconsin (USA). This pilot production served the purposes of further clinical testing as well as technical and regulatory quality assurance.

The production of the small batch marked the transition from the research phase to the production phase of a medical device and formed the basis for subsequent approval procedures and the planned market launch.

2009–2010 – Transition to market launch

Following investments of over 15 million US dollars, PATH sought an experienced industry partner for the regulatory approval, manufacture and distribution of the diaphragm in Europe and North America.

The aim was to meet the regulatory requirements in the respective target markets and to establish quality-assured production.

2011 – Transition to KESSEL Medintim GmbH

In 2011, responsibility for the further development, approval, manufacture, packaging and market launch of the diaphragm was transferred to KESSEL Medintim GmbH (Mörfelden-Walldorf, Germany).

The company has been marketing barrier methods since 1987 and has been a certified manufacturer of medical devices in accordance with ISO 13485 since 2005. With the transfer of the licence rights for approval, manufacture and distribution by PATH, the industrial implementation of the newly developed diaphragm began

The development name SILCS became the brand name Caya® Contoured diaphragm. At the same time, production was relocated to Thuringia (Germany).

2013 – Market launch of the Caya® Contoured diaphragm

The result of this decades-long development was the market launch of the Caya® Contoured diaphragm in 2013. The diaphragm was designed as a hormone-free contraceptive with a one-size-fits-most design.

The Caya® Contoured diaphragm has been manufactured in Germany (Thuringia) since 2011.

CE certification was granted in 2013. In the same year, the Caya® Contoured diaphragm was launched in Europe and Canada. On 9 April 2013, the first Caya® Contoured diaphragm was sold at the “Engel Pharmacy” in Fulda.

FDA approval was granted in 2014, followed by market launches in Canada, Australia and the USA.

Further approvals and market launches took place in 2020 in Colombia, Chile and Peru.

Today – The diaphragm method is back in vogue

Many women today want hormone-free contraception or make a conscious decision against hormonal contraceptives. Against this backdrop, the diaphragm is experiencing a renaissance as a modern contraceptive for use on demand.

As a hormone-free ‘on-demand contraceptive’, it combines safety with sustainability, flexibility and female self-determination.