What is FemiCushion?

FemiCushion is a medical device designed to alleviate the symptoms of pelvic organ prolapse.

Pelvic organ prolapse is also called “genital prolapse” or “vaginal prolapse”, and it is caused by the weakening of the pelvic floor muscles and ligaments that support the pelvic organs (uterus, bladder, urethra, small intestine, and rectum). The pelvic organ will start to drop from their healthy positions and into the vaginal canal causing pain and discomfort. It is a little-known disease, but it is said to affect one out of three adult women.

FemiCushion is a new medical device that helps patients improve their symptoms with an approach that is different from conventional treatments for pelvic organ prolapse. It can be easily put on and taken off by the patient and it does not involve inserting foreign objects into the body.

Keiko Mitsui of Mitsui Medical Japan, the inventor of FemiCushion, will explain the background of the development and the features of the product.

➀ History of its development

Based on my experience of giving birth three times, I focused on taking care of the pelvic floor muscles as they can be easily damaged during childbirth. Pelvic organ prolapse, which is said to affect one in three adult women, is caused by aging, pregnancy and childbirth. A pelvic organ prolapse specialist informed me that many women are suffering from this condition.

The pelvic floor muscles support the organs in the pelvis like a hammock and play an important role in excretion. Although postpartum women are busy with childcare, if the damage of childbirth and pregnancy is left untreated, problems such as urinary incontinence and pelvic organ prolapse are likely to occur.

Pelvic organ prolapse makes it difficult to lead a normal daily life, due to the many symptoms of this condition such as urinary and bowel problems, pain and discomfort in the abdomen, bleeding, unable to lift heavy objects etc.

FemiCushion was developed to help those who suffer from pelvic organ prolapse lead a comfortable life.

Pelvic organ prolapse is not a life-threatening disease, but once it occurs, it is difficult to cure it completely and surgery is required. It is said that 1 in 3 adult women are affected by this disease, but there are many women who are worried because they are unable to talk about this condition to others.

FemiCushion was developed after receiving various opinions from patients suffering from pelvic organ prolapse, and has since been used by many women worldwide.

➁ Features of FemiCushion

FemiCushion consists of three main components: cushion, holder, and supporter.
All components work together to provide support to prolapsed organs without having to insert a foreign object in the body.

Many patients find it difficult or embarrassing to discuss pelvic organ prolapse with others. Although FemiCushion is a medical device, we designed it to look like regular underwear so that other people will not notice it. This is a non-invasive treatment option that does not require foreign objects to be placed inside the body but is effective at relieving prolapse discomfort without damaging the prolapsed organ or vaginal mucous membranes.

We have received many positive feedback from patients who have used the FemiCushion, saying that their discomfort has disappeared and they can now live their lives with peace of mind.

Using FemiCushion can prevent the progression of symptoms and the severity of the prolapse, improve urinary problems, and allow women to live an active lifestyle.

FemiCushion is worn during the day and taken off at night when sleeping. The device is washed at the end of each use to ensure good hygiene.

➂ How Femicushion Is Different From Other Products (Counterfeit Products, Pessaries)

Another conservative treatment for pelvic organ prolapse is pessary use, the most common type being a ring pessary.

A ring pessary is a ring-shaped prosthetic device usually made out of silicone that is inserted into the vagina to support the prolapsed organ. Although it varies from person to person, inserting a foreign object into the vagina may cause pain and discomfort, as well as symptoms such as vaginal wall erosion (sores) and bleeding. In addition, regular visits to the hospital are necessary to remove the device, clean it, and insert it again once every two to three months.

On the other hand, FemiCushion does not need to be inserted into the vagina, but rather the cushion, holder, and supporter are used together to firmly support the prolapse at the vaginal opening and prevent it from bulging out of the body. Pelvic organ prolapse cannot be supported with a flat surface, therefore, FemiCushion uses a cushion to firmly support the prolapse in a way that does not cause discomfort. Additionally, there is no risk of the cushion getting dislodge into the vagina due to movement. The user has full control of the device, meaning they can wear it whenever and whenever they choose.

Unlike the ring pessary, which is a conventional treatment method for prolapse, FemiCushion is not inserted into the body, therefore it is suitable for women who:

・Experience pain or bleeding and are not suitable for ring pessaries
・Do not wish to have a foreign object in their body
・Waiting for surgery
・Cannot undergo surgery
・Do not want surgery
・Have difficulty going to the hospital or clinic

➃ How to choose a FemiCushion Kit

As FemiCushion is effective when the cushion, holder, and supporter are used together, Please purchase a starter kit which includes those three components.

The cushion is securely attached to the holder at the proper position. The holder also absorbs urine leakage and vaginal discharge. With the cushion fixed to the holder, it is then attached to the supporter.

The supporter is designed to mimic the look of regular underwear. Depending on the style of supporter chosen, the opening can be different. Please use the supporter that best suits your lifestyle.

Since the supporter is lifted by the vertical belt with the horizontal belt as the pivot, the cushion can be continuously fixed in place without putting pressure on the abdomen.

The supporter is designed to mimic the look of regular underwear. Depending on the style of supporter chosen, the opening can be different. Please use the supporter that best suits your lifestyle. Since the supporter is lifted by the vertical belt with the horizontal belt as the pivot, the cushion can be continuously fixed in place without putting pressure on the abdomen.

Supporters are selected and purchased according to the size of the waist circumference. Please select the size by measuring across the belly button and around the waist.

▼Supporter type comparison table

	Standard	EasyOpen	EasyZip
Features	Hook fasteners Has great elasticity to fit different body shapes.	Velcro fastener opening at the front (easy to take off and put on) Has great elasticity to fit different body shapes.	Zipper opening at the front Made with breathable cotton fabric.
Fabric	(Spandex) 　Nylon: 86% 　Polyurethane: 14%	(Spandex) 　Nylon: 86% 　Polyurethane: 14%	(Cotton) 　Cotton: 70% 　Polyurethane: 30%
Leg Length	Briefs cut	Briefs cut	Boy short cut
Recommended for women who:	Prefer high-wasted clothing. Prefer no opening at the front.	Have urinary incontinence and use the restroom frequently. Older in age. In assisted living/nursing home.	Does not like high-waisted clothes. Prefer cotton fabrics. Prefer to have a longer leg pant.

▼Selecting the Size of the Supporter

For first time users, it is recommended to wear the device while lying down on your back, knees raised and spread apart. Use one hand to spread open the vagina then place the cushion that is attached to the holder against the vaginal opening with the other hand. It is recommended to use a water based jelly lubricant on the cushion to prevent chafing.

Slip on the supporter then stand up to adjust the belts. Position the horizontal belt where it will be supported by the hipbone. Next, tighten the vertical belt, this will lift the cushion up closer against the body providing secure prolapse support. The belts attached to the supporter do not stretch even when pressure is applied to ensure that the cushion is fixed firmly in place.

Important Points to Remember:

・Return all prolapse organs inside the body before putting on the device.
・Adjust both the horizontal and vertical belts to your body shape for firm support.

If the device is worn correctly, the cushion will hold the organ securely in place no matter what movement is performed.

Walking is also an excellent treatment for pelvic organ prolapse to strengthen the pelvic floor muscles and improve symptoms. With the Femi cushion, you can walk and exercise with peace of mind. As symptoms improve, you can downgrade to a smaller cushion size.

In the unlikely event that the prolapsed organs bulge out of the body after using the bathroom, return the organs inside the body before putting on FemiCushion again.

For women who are prone to rashes, please ask for a prescription for ointment and use it accordingly.

To clean the device, first disassemble the device. For the supporter, place the surface fastener tape back on the velcro strip located at the crotch area. We recommend hand washing the supporter with a mild soap then air dry. For machine wash, please use a laundry net and wash on a gentle cycle. A dryer can also be used, but please note that the supporter can shrink slightly. For the holder, hand wash is recommended but it can also be machine washed in a laundry net on a gentle cycle then hung dry. For the cushions, first plug the air hole on the underside of the cushion using the cleaning plug provided. Then wash the cushion with lukewarm water and a mild soap. Dry the cushion is a cool dark place.

➄ Frequently Asked Questions About FemiCushion

・Can I ride a bicycle with FemiCushion on?

If you don’t feel any discomfort, you can ride your bicycle while wearing the device. If you feel uncomfortable, you can still wear the device but remove the cushion component then attach it back to the device when you arrive at your destination.

・Can people with dementia use FemiCushion?

Yes, as long as the caregiver understands how to use it.

・Is FemiCushion covered by insurance?

FemiCushion is not covered by insurance. It is classified as a Class 1 medical device, and patients will have to pay for it themselves. Although not covered by insurance, it is a medical device, therefore it can be subject to a medical expense deduction on tax returns.

・How do you use the bathroom with FemiCushion?

Using the restroom with FemiCushion is simple and is very similar to taking off regular underwear. Undo the supporter then slip it down. All components will be secured together for easy wear afterwards. If there is no prolapse after you’re finished using the restroom, you may put on FemiCushion as usual. In the event of prolapse, reposition any prolapsed tissues inside the body before wearing the FemiCushion. This can be done with a clean finger. Finally, pull the supporter back on while making sure to place the cushion in the proper position and secure the supporter. Then adjust the belts to your liking.

・Can FemiCushion be used during menstruation?

FemiCushion can be used even during menstruation. We recommend using a disposable holder that functions as a sanitary pad. Additionally, the cushion component can be washed after every use to keep it hygienic.

⑥ Summary

FemiCushion is a medical device developed to improve symptoms of pelvic organ prolapse. It is a non-invasive treatment method that does not require a foreign object to be inserted into the vagina. FemiCushion features a cushion component that provides gentle but firm support from the outside which is mentally and physically less burdensome. FemiCushion is effective at relieving prolapse symptoms such as bleeding, pain, and discomfort and it also prevents the prolapse from progressing. We hope that this product will help patients suffering from pelvic organ prolapse to lead a comfortable daily life.