Epino or Aniball????

[SarahBroom]

Hello everyone,

does anyone here have an experience with either Epino or Aniball please??? I'm really scared of tearing and I've found these working pretty good according to reviews on forums and blogs. At least they seem to help with the confidence. They both look basically the same so I'm not sure if there is any real difference???

There is a review directly comparing both medium.com/@janestinson/epi-no-vs-aniball-my-personal-experience-a0c0829a4d32 saying they both do the job. So really not helpful at all :D There is a note about Epino being banned in the USA because of some incident but I'm not sure about that one.

Please let me know your thought's, the clock is ticking and I'm worried :D

Kind Regards,
Sarah

also both websites if anyone is lost: epino - epi-no.co.uk/ and aniball - aniball.uk/

Epino caused someone to tear very badly. Why not just get some plain oil and DIY?

There's no solid evidence that it works, although the studies suggest it at least won't harm you. Think about positions in the second stage and avoiding directed pushing.

Hi all, we were contacted by EPI-NO and offered them a right to reply - here's their response:

[quote] The incident, Sarah Broom refers to, happened in 2006 in New York and has been published on the FDA website unaudited. A pregnant woman was lying on her couch with the balloon inserted, and her husband was inflating the balloon. It transpired that she was using a second hand device from 2003 and the balloon had a hole in it. Her husband had not checked the balloon for imperfections before use and continued to pump the balloon for over 10 minutes. This was obviously improper use of the Epi-no as the instructions clearly state:

" Inflate the balloon before each application to approx. 7 cm diameter (3 inches - s. fig. operating instruction) and examine it for any imperfections and possible punctures. Never use a defective device."

Nonetheless an article had been published at the Green Journal by Ms. Linda Nicoll, describing that case and just assuming that there had been a case of air embolism. The recommendation of this article was not to ban the use of the EPI-NO, but to place according warnings with the instructions for use. These instructions had been and are very clear. The FDA did not take any action and did not ban EPI-NO in the US.

EPI-NO has never been banned in any country - the reason that it is not in the US is because in 2007 the FDA changed the status of EPI-NO from Class I to Class II or higher classification. EPI-NO is a unique device, therefore there are no required 'predicate devices' (you need 3 at least) with an appropriate or same indication for use for a Class II device, already existing in the US market. This meant the manufacturer would have to submit a PMA (Premarket Approval / Class III.) procedure causing extreme costs.

EPI-NO is a clinically tested, safe device. More than 265,000 EPI-NO's have been in use since 1999 and not a single adverse event has been reported or published since this incident. In 11 clinical studies with over 1,200 participants using the EPI-NO not a single health risk or adverse event has ever been reported. [/quote]

[message edited by MNHQ following further correspondence with EPI-NO]