January 6, 2011
Hundreds Of UK Women Pregnant Despite Contraceptive Use
Merck & Co. is now defending the Implanon contraceptive after reports of over 500 women in the UK becoming pregnant despite using the implant.
The Implanon contraceptive was designed to prevent women from becoming pregnant for up to three years by releasing etonogestrel, a synthetic progestogen into the bloodstream after implantation into the upper arm.
Implanon has been purchased more than 1 million times since it was allowed on the market in Britain in 1999.
Ronald Rogers, a spokesman for the New Jersey-based Merck & Co., told the Associated Press (AP) that 600 pregnancies among Implanon's 1 million UK users translates into a rate of less than one percent. "No form of contraception is 100 percent effective," he added.
"We're very confident in the efficacy and safety of Implanon," Rogers told AP, adding that "it is more than 99 percent effective."
Britain's Healthcare Regulator said in a statement that "Implanon is a safe, effective and reliable contraceptive when used correctly." The agency recommended that any women worried about their contraceptive implants should use a condom as well for extra protection or talk to their doctor.
The Medicines and Healthcare Products Regulatory Agency (MHRA) also confirmed it had received a total of 1,607 adverse drug reaction reports linked to Implanon, relating to 2,888 incidents of suspect reactions in users.
The National Health Service has paid out more than 200,000 pounds (310,000 dollars, 235,000 euros) in compensation to women who fell pregnant or were injured by the implant, according to media reports.
A lawyer for some of the women claiming for personal loss and damage said many had not realized the pre-loaded applicator had failed to release the implant into their bloodstream. Stephanie Prior, partner of Anthony Gold Solicitors is quoted by Ruters as saying: "Nexplanon has a new pre loaded applicator which is designed to reduce the risk of insertion difficulties and it is radio-opaque so that it can be identified on an X-ray or CT scan if necessary."
Ms. Prior continues, "I have clients who fell pregnant as they were unaware that the Implanon device had not been inserted into their arm and they suffered psychological difficulties as a consequence of falling pregnant and later miscarrying or having to make the difficult decision to terminate the pregnancy."
In a statement, Implant manufacturer MSD said it was "confident in the efficacy and safety of Implanon" but suggested that many of the women who became pregnant may have had the device badly fitted by a medical practitioner.
"The basis for successful use of Implanon is a correct and carefully performed sub dermal insertion of the implant in accordance with the product instructions," MSD continues. "If the implant is not inserted in accordance with the instructions and on the correct day, this may result in an unintended pregnancy. In addition, no contraceptive is 100 percent effective."
On the Net:
- Merck & Co.
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- National Health Service