Seven years of Caya® Diaphragm – a success story

(Mörfelden-Walldorf, 09.04.2020)
On April 9, 2013, the first Caya® diaphragm was delivered to the Engel Apotheke in Fulda. Since then, in seven years, several hundred thousand women worldwide have chosen the Caya® Diaphragm for safe, simple and above all hormone-free contraception.

Where does this success come from?
The annual Caya® user surveys show a current trend:

More and more women want to use hormone-free and safe contraception without side effects – and only when it is necessary. The majority of women who decide to use hormone-free contraception have taken the “Pill” or used another hormonal method of contraception before.

The trend is away from hormonal contraception and towards self-determined methods that are easy to reverse if there is the desire to have children. This view applies to sexually active women at different stages of life and at different ages. But in poorer countries with more difficult conditions in terms of medical care, this development can be observed, too.

Beginning of the development
The PATH Foundation, based in Seattle, USA, developed the novel diaphragm from 1996-2011. The following aspects should be decisive in this process:

– a single size for the majority of women
– polymer spring instead of metal (patented)
– anatomical form
– silicone instead of latex

PATH has been developing medical technology for family planning, vaccines and other health protection improvements for over 35 years. Since 2010 KESSEL medintim GmbH has been a contractual partner of the PATH Foundation, which ultimately led to the cooperation and market launch of the Caya® diaphragm.

Milestones in development
2013 CE certification as medical device
2014 FDA approval for USA
2014 Canadian Health Approval
2015 TGA approval Australia
2016 Registration and distribution in Morocco
2019 Registration and distribution in Niger (Sahel)
2019 Registration in Nigeria completed
2020 MDSAP qualification including ANVISA Brazil
2020 Registrations in Central and South America
2020 Registration and distribution in Benin (West Africa)

An overview of all countries and sales partners can be found at www.caya.eu.

Distribution in Czech Republic

As a certified manufacturer, we are happy to work with the most qualified partners when selling our products.

In the Czech Republic we have been cooperating for many years with Mrs. Jana Musialková Muroňová from the company ForLady Pharma for the distribution of the gynaecological product line and with Mr. Jakub Fridrich from the company Falconik for the andrological product line.

We look forward to continuing this cooperation successfully in the future.

 

Best regards,
Kessel medintim GmbH

Singa®: distribution of the new diaphragm

KESSEL medintim GmbH is preparing the distribution of the new Singa® diaphragm. The registration documents have been submitted since the end of June 2019. According to current information, the first Singa® diaphragms could be delivered in February 2020.

Important note: As soon as the Singa® diaphragm is available, it will be announced at www.medintim.de. Please refrain from previous telephone enquiries. It is possible to be placed on an information waiting list by e-mail: Prospective customers may write a short e-mail to service@medintim.de.

 

What’s new about the Singa® Diaphragm?

The Singa® diaphragm is named after the inventor of the diaphragm Johann Wilhelm Mensinga (1836 – 1910), a pioneer of modern contraception. In 1881, Dr. Mensinga developed the world’s first diaphragm in the form of a round rubber cap and recommended it for birth control.

The Singa® diaphragm will be round in its traditional form and provided with a membrane. The available sizes also correspond to the classic diaphragm: 60mm, 65mm, 70mm, 75mm, 80mm, 85mm and 90mm outer diameter.

New features of the Singa® diaphragm will be the material and the spring washer: In conventional diaphragms, the spring was made of metal (spiral spring and/or flat band spring), coated with latex or silicone.

The Singa® diaphragm, like the Caya® contoured diaphragm, will have a polymer (Nylon®) spring washer that has better properties than metal springs and is also lighter. The Singa® diaphragm is also color-coded to match the Caya® contoured diaphragm, as shown in the picture.

The Singa® diaphragm is based on the technology and manufacturing experience of the Caya® contoured diaphragm. This anatomically and ergonomically shaped diaphragm was launched by KESSEL medintim GmbH in April 2013. Over 200,000 women have opted for it to date.

 

Why a round, traditional diaphragm continues to be necessary

The Caya® diaphragm is suitable for a good 87% of all women. However, the remaining 13% require a different diaphragm for anatomical reasons in order to be able to use contraception safely.

The Singa® diaphragm will therefore be of interest to the following women:

– Women who need a smaller diaphragm than the Caya® Diaphragm (60mm diameter)

– Women who need a larger diaphragm than the Caya® diaphragm (85mm and 90mm diameter). These are women who may already have had several vaginal deliveries.

– Women who need a firmer spring tension than the Caya® diaphragm offers. The Singa® diaphragm has a slightly firmer spring tension and therefore sits more firmly in the upper vaginal vault than the Caya diaphragm.

As with all traditional diaphragms, the size of the Singa® diaphragm must be adjusted by a professional (gynaecologist, midwife, family planning clinic) before first use.

The Caya® contoured diaphragm will continue to be the most widely used diaphragm in the world. Further information can be found at www.caya.eu. With its seven sizes, the Singa® diaphragm gives all women the opportunity to use a diaphragm as the contraceptive method of their choice.

Do you have any questions? Write to us: service@medintim.de

 

Kind regards,

KESSEL medintim GmbH

 

download press release as pdf

Niger: launch of Caya® Diaphragm and Caya® Gel

FRANKFURT, SAN DIEGO, WASHINGTON
KESSEL MEDintim, WCG Cares (WCG) and Population Services International (PSI) announced the launch of the Caya® Diaphragm and Caya® Gel in Niger.

The introduction of the Caya® Diaphragm and Caya® Gel in Niger is supported by the Expanding Effective Contraceptive Options (EECO) project, which is funded by the United States Agency for International Development (USAID).

The EECO project, led by WCG and implemented in partnership with PSI, was designed to support the introduction of new and improved contraceptive methods that address method-related reasons for non-use of family planning to better meet the reproductive health needs of women and girls worldwide.

The launch of the Caya® Diaphragm and Caya® Gel, a non-hormonal, discreet and reusable barrier method, supports WCG’s and PSI’s joint efforts to expand access to an array of contraceptive options. PSI will market and distribute the Caya® Diaphragm and Caya® Gel in Niger’s capital of Niamey, training community health workers and healthcare providers to offer the method to women alongside other options within the context of informed choice.

 

Niger has one of the world’s highest fertility rates, with women having more than seven children in their lifetime on average, in part due to extremely low use of contraception. Yet the Government of Niger is committed to increasing contraceptive use not only as a means to reduce maternal and child morbidity and mortality but also to boost economic development.

KESSEL MEDintim, WCG and PSI are dedicated to increasing access to a full range of contraceptive options in Niger, including those that respond to preferences for non-hormonal, on-demand methods like the Caya® Diaphragm and Caya® Gel. Unlike previous iterations of the diaphragm, the Caya® Diaphragm is “one size fits most,” eliminating the need for a provider fitting in countries like Niger with shortages of trained healthcare providers. 

“Our market research shows that women and men desire more contraceptive options that are within their control and have no side effects,” said Moumouni Boubacar, EECO Project Manager at PSI Niger. “The Caya® Diaphragm puts power in the hands of the couple, which can decide when they want to start and stop contraception with no need to see a provider in a busy health care center.”

 

“We are excited to see the response of women and providers to the Caya diaphragm—especially​ to see if Caya can help meet the needs of women who do not want to use other types of contraceptives,” said Martin Kessel, CEO of KESSEL MEDintim. “We know women in other countries have easily learned to use Caya and like this new method, so in Niger this will be explored. Since diaphragms have not been available or promoted in decades, we are not just testing acceptability of another variation of a contraceptive, we are introducing a new type of method to women and their partners, and even to family planning providers, who have not had an option like this before.”

“Women’s contraceptive needs change throughout their lives and they need methods that align with their unique circumstances,” said Shannon Bledsoe, WCG Executive Director. “The introduction of this on-demand, non-hormonal method gives women in Niger one more contraceptive choice.”

 

About KESSEL MEDintim

KESSEL Medintim is a manufacturer of medical devices, specialized in contraceptives and health care products for men and women. The company is based in Mörfelden-Walldorf, Germany and supplies more than 40 countries through a network of local partners. KESSEL Medintim is ISO CE 13485 certified for research, development and manufacturing with extended MDSAP approval for the USA (FDA), Canadian Health and Australia (TGA). With more than 30 years of experience, KESSEL Medintim is highly innovative with new technologies and uses advanced materials.

 

About WCG Cares

WCG is an international non-profit organization committed to empowering, educating and enabling women and girls to make informed choices and access critical reproductive health products and services. WCG’s credentials in product introduction have made it a preferred partner of organizations looking to move products from laboratories and manufacturing plants to the women who need them. WCG excels at forming strategic partnerships to introduce and create access to new contraceptive methods around the world. For more information, visit www.wcgcares.org.

 

About Population Services International

Population Services International (PSI) is a leading global health organization working in reproductive health, HIV, malaria, child survival, non-communicable diseases and sanitation. Partnering with the public sector and harnessing the power of markets, PSI helps people in the developing world lead healthier lives and plan the families they desire. PSI manages social franchises that provide affordable health care products and services, as well as empowering communities and families through health education. PSI runs programs in 50 countries across the world and operates franchise networks in 30 countries in Asia, Africa and Latin America. For more information, visit www.psi.org.

 

Photo credit: © PSI/Alexandra Angel

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Counterfeits of Vacuum Erection Devices

Warning

 

The company KESSEL MEDintim GmbH is manufacturer of the medical devices ACTIVE Erection System NT® & MANUAL Erection System® and warns expressly against the purchase of plagiarisms from Pakistan.

The PDF attached below gives an overview of the differences between the original and the counterfeit and is intended to warn against the purchase and use of such counterfeits.

Attention: These counterfeits are not approved products.

KESSEL MEDintim GmbH does not assume any liability for counterfeit products on the market.

If you notice such a counterfeit, please inform us at service@medintim.de or +49 (0) 6105 – 20 37 20.

 

Best regards,

KESSEL MEDintim GmbH

Download overview as PDF

Singa®: Production and distribution of the new diaphragm

 

KESSEL MEDintim GmbH is preparing the production and distribution of the new Singa® diaphragm. It is to be delivered in late summer 2019.

Important note: As soon as the Singa® diaphragm is available, it will be announced at www.medintim.de. Please refrain from previous telephone enquiries. It is possible to be placed on an information waiting list by e-mail: Prospective customers may write a short e-mail to service@medintim.de.

What’s new about the Singa® Diaphragm?

The Singa® diaphragm is named after the inventor of the diaphragm Johann Wilhelm Mensinga (1836 – 1910), a pioneer of modern contraception.

The Singa® diaphragm will be round in its traditional form and provided with a membrane. The available sizes also correspond to the classic diaphragm: 60mm, 65mm, 70mm, 75mm, 80mm, 85mm and 90mm outer diameter.

New features of the Singa® diaphragm will be the material and the spring washer: In conventional diaphragms, the spring was made of metal (spiral spring and/or flat band spring), coated with latex or silicone.

The Singa® diaphragm, like the Caya® diaphragm, will have a polymer (Nylon®) spring washer that has better properties than metal springs and is also lighter. The Singa® diaphragm is also color-coded to match the Caya® diaphragm, as shown in the file below.

The Singa® diaphragm is based on the technology and manufacturing experience of the Caya® contoured diaphragm. This anatomically and ergonomically shaped diaphragm was launched by KESSEL MEDintim GmbH in April 2013. Over 150,000 women have opted for it to date.

Why a round, traditional diaphragm continues to be necessary

The Caya® diaphragm is suitable for a good 87% of all women. However, the remaining 13% require a different diaphragm for anatomical reasons in order to be able to use contraception safely.

The Singa® diaphragm will therefore be of interest to the following women:

– Women who need a smaller diaphragm than the Caya® Diaphragm (60mm diameter)

– Women who need a larger diaphragm than the Caya® diaphragm (85mm and 90mm diameter). These are women who may already have had several vaginal deliveries.

– Women who need a firmer spring tension than the Caya® diaphragm offers. The Singa® diaphragm has a slightly firmer spring tension and therefore sits more firmly in the upper vaginal vault than the Caya diaphragm.

As with all traditional diaphragms, the size of the Singa® diaphragm must be adjusted by a professional (gynaecologist, midwife, family planning clinic) before first use.

The Caya® diaphragm will continue to be the most widely used diaphragm in the world. Further information can be found at www.caya.eu. With its seven sizes, the Singa® diaphragm gives all women the opportunity to use a diaphragm as the contraceptive method of their choice.

 

Do you have any questions? Write to us: service@medintim.de

 

Best regards,

KESSEL MEDintim GmbH

download press release as pdf

Caya user survey 2018: The results

The diaphragm’s renaissance

Also this year, the company KESSEL medintim GmbH, asked the Caya users to participate in the annual Caya survey. Now it has been the fifth time already.

As always, we were interested in the following: Who are the users? What does their lifestyle look like? How satisifed are they with the Caya?

We are pleased with the positive results that can be downloaded below. After 5 years and approx. 150,000 Cayas on the market, we were able to start a revival of the diaphragm as contraceptive method.

For more information, contact us:

service@medintim.de

+49 (0) 6105 – 20 37 20

Download user survey results

Important information: Availability of Milex Wide Seal

Milex Wide Seal Diaphragm, Size 60 - 90 mm

The diaphragms of the manufacturer MILEX (USA) of the brand Wide Seal, sizes 60 to 90 mm, are no longer available in Europe.

In the US these diaphragms are not available online, but only directly from the gynecologist. In addition, they are available only on prescription.

Women who previously used a classic diaphragm of sizes 65mm, 70mm, 75mm or 80mm can alternatively use the CAYA® contoured diaphragm. The Caya® Diaphragm is available without a prescription in pharmacies and online.

Women who want a diaphragm of size 60mm, 85mm or 90mm can temporarily not find these sizes on the market.

We are currently preparing a traditional diaphragm in sizes 60 – 90mm and will launch it in the first half of 2019. More information will then be published.

 

 

download press release as PDF

Post marketing survey for Vacuum Erection Devices (VED)

Latest Results: Jan 2017 – Aug 2018
Active Erection System® and Manual Erection System®

Since January 2017 until today, the users of the vacuum erection devices Active Erection System® and Manual Erection System® were directly questioned.

We were interested in the degree of satisfaction with the product and in the frequency of use, but also in the age- and health-related prior history of the respondents. The survey was undertaken by company KESSEL MEDintim GmbH. As gratification each respondent received a tube of Animé lubricant as well as two constriction rings.

Overall, the survey reached 2500 men so far, and due to the very personal nature of the topic, it was partly also anonymous. This third assessment is based on the answers of the first 300 respondents.

Download results of user survey