Wednesday, March 2, 2016

Human Contraception: The Bimek SLV

Good bye Vasectomy. Hello sperm switch: Men can turn fertility on and of with new ‘Sperm Switch’.

German carpenter invents contraception switch that turns off flow of sperm.


Soon, you might be able to say goodbye to vasectomies and hello to a tiny device that seems straight out of the pages of a sci-fi novel.

A German carpenter named Clemens Bimek has invented a form of male contraception meant to let men control their sperm flow with the flip of a switch.

The device, called the Bimek SLV, is “as small as a gummy bear,” according to its site, and is surgically implanted and attached to the vas deferens, or spermatic ducts. It has a valve that can be opened and closed with a switch that can be accessed through the scrotum’s skin:

The Bimek SLV, a device for reversible male contraception, is supposed to work through a switch that can be flipped through the skin of the scrotum.

When the valve is closed, it diverts sperm cells by pushing them sideward, which prevents them from reaching the seminal fluid. This makes a man sterile upon ejaculation. The procedure works similarly to a vasectomy, except a vasectomy can only be reversed occasionally and through complicated surgery. But with this device, which is 100 percent vegan, the procedure could be reversed with just another flip of the switch.

According to German magazine Spiegel, Bimek got the idea 20 years ago while watching a documentary about contraception. In 2000, he filed a patent.

“Many doctors that I have consulted, have not taken me seriously,” Bimek told Spiegel. “But there were also some who have encouraged me to continue to tinker and who have supported me with knowledge.”

Wolfgang Bühmann, spokesman for the Professional Association of German Urologists, told Spiegel that he think this procedure will cause scarring, which can prevent sperm from flowing even when the valve is open. Bühmann also warned that if the valve is closed for too long a time, it could get clogged.

But it's not yet clear whether this will be the case: Thus far only Bimek himself has had the 30-minute implant procedure -- and Philipp Renger, who is in charge of marketing the Bimek SLV, told CBC Radio it didn’t go that well.

"When it was implanted he found that it was difficult to open and close it," Renger said.

Bimek had to redesign the device and have follow-up surgeries, according to CBC.

"It sounds terrible ... but it worked really well," Renger said.

The company is looking to implant the device on 25 men this year, and wants a final product by 2018.

Any volunteers?


From Mashable.com:
Do you have a condom? No, but I have a sperm switch on my balls.Bimek-slv-thumbnailIMAGE: BIMEK SLVPhoto

BY ALICIA MARIE TAN
When we think about birth control, we tend to think of women. But a German inventor wants to flip the switch on that discussion with his latest creation.

Introducing the “sperm switch,” named the Bimek SLV, which is the brainchild of Clemens Bimek. The device claims to allow men to block sperm from mixing with semen before ejaculation.

It’s Bimek’s answer to male contraception and an alternative to a vasectomy.


During a vasectomy, the tubes that carry sperm are closed or blocked, and sperm can no longer enter the seminal fluid. Instead, the body absorbs the sperm.

While it’s one of the few options men have to prevent pregnancy, the procedure is meant to be permanent. If a man changes his mind later and wants to have a child, many vasectomies can be reversed up to a certain point, but there are different factors involved so restoring fertility successfully isn't guaranteed.

Bimek wants the Bimek SLV to give men the freedom to decide whether to have a child with the push of a button, without having to opt into something permanent.

But how exactly would it work?

The SLV consists of a valve that is mounted on each spermatic duct, according to Bimek's company. When the switch is closed, it disrupts the flow of sperm cells, and allows the sperm to be absorbed into the body.

When it’s open, it allows sperm cells to pass through the ducts. The valve switch can be felt and toggled with your fingers through the scrotum skin. There’s also a safety pin as an added security so the switch doesn’t turn on accidentally.




bimek slv illustration

IMAGE: BIMEK SLV



The switch — which is 7 x 11 x 18 mm — is primarily made of PEEK Optima, a biomaterial used for medical implants like cranial and dental implants. Other parts like screws and springs are made of a non-magnetic metal alloy, according to the company.

The device is designed to be inserted under local anesthesia in a half-hour long procedure, according to the company’s website:
Each spermatic duct is transected, then the newly cut ends are connected to the valve casing using specially developed instruments. The spermatic ducts are then put back into the scrotum and the inner and outer dermal layers are sealed – then you can head home.
Sounds quick and painless, but there are caveats.

The biggest one is that the SLV is not yet officially approved. Before the device can be sold in the U.S., it has to face stringent procedures for approval from the Food and Drug Administration. Clemens Bimek had the SLV implanted in himself in 2009, but the device still has to undergo clinical trials where volunteers are tested to make sure it’s safe and effective.

Bimek hopes to fund the device through 5 million euro (about $5.5 million) of investment, including crowdfunding, according to the Daily Mail.

The first tests of the SLV will happen with 25 men this year, according to a report. There are other technical checks, like manufacturing certification, packaging and sterilization.

Another thing to keep in mind is that the SLV is implanted in its open state. Once the valve is closed, there will still be sperm cells present in ejaculatory fluids for up to three months, or about 30 ejaculations. So it’s recommended that men who get an SLV undergo a sperm analysis with a urologist before they let loose and assume they're good to go.

That's unlike an IUD, or "intrauterine device," a form of birth control women insert to prevent sperm from joining with an egg. Some women can have sex as soon as an IUD is inserted, although that depends on exactly when in a woman's menstrual cycle the IUD is inserted.

And like many medical inventions, not all experts are sold on the idea. According to the Daily Mail, Wolfgang Buhmann, a spokesman for the Society of German Urologists, said the valve could have negative side effects.

For example, the valve could lead to scar tissue building up in the seminal ducts, which could stop sperm from traveling through the tubes and cause long-term infertility issues. Another concern is that sperm could stick to the valve and clog up the switch over time.

And if there is one thing that guys really hate, it's a clogged sperm switch.



IMAGE: MASHABLE SCREENSHOT.BIMEK SLV
If the device works safely and effectively during and after clinical trials, Bimek could have a success on its hands. And while it could be useful, it shouldn’t be the end-all be-all, although the company sometimes markets it as that. Here’s one instance on the company’s website:
Half way through and searching for condoms? Need to insert your diaphragm? Forget to take the pill? Is your fertility window really over? What if you could simply forget about contraception? We want you to be able to concentrate on what's important, spending time together without having to worry about contraception. To simply let go and enjoy.
While simply letting go and enjoying sex would be nice, it’s not realistic.

For one, condoms prevent more than just pregnancies. They also help guard against sexually-transmitted infections and diseases.

So the SLV might best suit those who are already married, have families or are in long-term committed relationships. Not to mention, if you have to wait a few months to make sure all the sperm is gone, it’s not the sort of device you quickly flip on and off in the heat of the moment. It really is something you have to remember is there and requires some advanced planning.

The calculated cost of the surgery and SLV is about $5,460. If trials and federal certifications check out, the company hopes to have the product to be available on the market in 2018.


And From The manufacturer:

WE MAKE CONTRACEPTION A MAN’S BUSINESS

with the Bimek SLV, the spermatic duct valve from Clemens Bimek

One valve is mounted on each spermatic duct and disrupts the flow of sperm cells when closed. The user is then sterile, can wear the Bimek SLV for a life time and regulate it himself with just a flip of a switch. Taking any hormones or medication is unnecessary, for both men and women.

Before you can benefit from the fully-developed, internationally-patented spermatic duct valve, we need to show the Bimek SLV’s capabilities in a medical approval procedure. To do this we run technical tests with volunteer subjects. Since its invention and in moving forward we engage in absolutely no animal testing, making the Bimek SLV 100% vegan.

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