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Monday, February 21, 2011

Implanon Contraceptive Implant Failed To Prevent Hundreds Of Pregnancies

Implanon Contraceptive Implant Failed To Prevent Hundreds Of Pregnancies

A popular contraceptive implant has come under scanner after hundreds of women became pregnant after the long-term contraceptive device failed to be properly inserted, according to multiple online media reports.

Implanon is a hormone-filled tube inserted underneath the skin in the upper arm. The device slowly releases the female hormone progestogen to prevent pregnancy for up to three years.

Implanon Contraceptive Implant Failed To Prevent Hundreds Of Pregnancies

Developed by Merck & Co., Implanon was first authorized in 1999, and since then more than 1 million implants have been sold.

Implanon users suffered unplanned pregnancies
But the effectiveness of synthetic progesterone-filled plastic rod undetectable by X-ray is now doubted after hundreds of women reported unwanted pregnancies, or experienced scarring and other problems after using the device.

Nearly 600 women in Britain complained to medical regulators that they have become pregnant despite using a contraceptive implant fitted in their arms, the government's drugs and medical devices watchdog said on Wednesday, according to reports by Reuters and The Associated Press.

On Wednesday, the Medicines and Healthcare Products Regulatory Agency (MHRA) said it had received more than 1,500 complaints of adverse side effects, including pain and scarring, linked to Implanon since it was licensed in Britain in 1999.

Also, 584 women have reported unwanted pregnancies, the agency said.

MHRA issued advice
Amid the recent media coverage regarding the effectiveness of contraceptive implant Implanon, the UK drugs regulator said they are keeping the device under “close review” and have issued advice on the agency’s official website to healthcare professionals about how to approach the issue with patients.

The MHRA statement says: “There have been reports of problems with inserting and removing Implanon. In some women who have had an unintended pregnancy, Implanon was found not to have been inserted at all. These issues have been kept under close review.”

The agency also recommends women to check if they can feel the device after implantation and also encourages physicians who wish to fit Implanon to undergo suitable training.

“If the implant cannot be located this does not necessarily mean that Implanon is not present, and women may wish to ask for confirmation of its presence at the next routine appointment with their Implanon fitter … In the meantime if women are in any doubt about the presence of Implanon they should use a condom,” the MHRA statement reads.

Merck backs Implanon
Meanwhile, a spokesperson for the New Jersey-based manufacturer of Implanon, MSD, said that "MSD is confident in the efficacy and safety of Implanon," as reported by Wall Street Journal.

"Since its initial approval in September 1999, more than 1.3 million units have been prescribed in the U.K.,” he said, adding that "Implanon is more than 99% effective."

The Merck spokesman continued: "MSD encourages women to speak with their health-care providers if they have any questions about contraceptive options and to report any adverse experience associated with any MSD medication."


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