15:29 18 October 2015
A study has found that that Essure, an implant used by the NHS to sterilise women, is ten times more likely to require a repeat operation when compared to other conventional sterilisations. Regulators said that although the device is safe, they are monitoring it following complaints from users about side-effects such as pain and misplacement.
Study author Dr Art Sedrakyan said: "It may not sound many but this is a commonly done procedure so that makes it relevant.
"Our study is very helpful. It shows how Essure compares with the main alternative, which means women can weigh the benefits and harms and regulators can make better decisions."
Meanwhile, Bayer says Essure’s safety and efficacy are backed up evidence. The company pointed out the women who have received Essure receive a routine check-up three months after the device is fitted.
"Because there is no confirmation test that could identify potential failure of a laparoscopic tubal ligation procedure, it stands to reason that the comparative reoperation rate would be lower," said a spokeswoman.