Saturday, September 17, 2016

Philippine DOH's Implanon is a discontinued drug

The Philippine Supreme Court recently halted the distribution and sale of the contraceptive implant known as “Implanon” and "Nexplanon" that was reportedly a donation from the Bill & Melinda Gates Foundation:

"The SC ruling issued on Aug. 24 means the 400,000 subdermal contraceptive implants—including Implanon and Implanon NXT, supposedly the most effective forms of birth control—that former Health Secretary Janet Garin had procured at P500 each, or one-tenth of the P5,000 market price with the help of the Gates’ foundation, would remain in government warehouses unless the DOH and FDA can convince anti-abortion groups they are not abortifacients."

Many Filipinos are not aware that Implanon is already discontinued and was replaced by Nexplanon. One question that arises is how much of the inventory in the warehouses is composed of the discontinued drug Implanon.

"One version of contraceptive implant — Implanon — was recently discontinued by its manufacturer and replaced with a newer version called Nexplanon. Nexplanon is radio opaque, which means it can be seen on X-ray, which is useful for checking the location of the implant. Nexplanon is the only contraceptive implant with Food and Drug Administration approval available in the U.S."

Also, there have been many reports of Implanon getting lost in women's bodies that there is now a class action suit in the United States:

"You may not have heard much about Implanon birth control previously. But you will, given the emergence of an Implanon birth control personal injury lawsuit that’s been filed as a class action. The issue in the current lawsuit is device migration. But there can be other issues as well....

“Implants have been reported to be found in a blood vessel including a blood vessel in the lung.”

“Implants have been found in the pulmonary artery (a blood vessel in the lung). If the implant cannot be found in the arm, your healthcare professional may use imaging methods on the chest. If the implant is located in the chest, surgery may be needed.”

There have been a number of news reports on the Implanon disasters since 2012 so another question is whether the Philippine DOH was aware of these issues at that time:

"Implanon's manufacturer MSD, a subsidiary of pharmaceutical giant Merck, replaced Implanon with an updated version called Nexplanon — available in the U.K. and U.S. — that has a new, improved applicator. It also contains barium, which makes it easier for doctors to track it down if it gets loose. But the company hasn't recalled Implanon that's already out there. A spokesperson for the company says the missing implants are usually just in too deep, and rarely actually move around, and that doctors have ways to find them. Still, says Lindsay Cross at Mommyish, knowing that there are any women out there who are stuck with a "missing matchstick floating around inside of them releasing hormones" is, or should be, a PR disaster."

There were also reported complaints from the United Kingdom:

"The controversial implants first hit the news last year when a group of women launched legal action after they received the device but still became pregnant.

A total of 584 women who had the small rod inserted in their arms reported unwanted pregnancies to the Medicines and Healthcare Regulatory Agency – a watchdog group for drugs and medical devices in the United Kingdom. The MHRA found in some cases that the device had not been inserted at all."

Given the above developments, perhaps it is a good time to ask why the Philippine DOH still plans to use the implants in the country.

It is also worth noting that a post assessment in Ethiopia on why women were requesting premature removal of the implants revealed the following:

"This study examined the main reasons for premature discontinuation of Implanon among users and median duration it was used before removal. As expected, heavy/prolonged bleeding was the main reason for premature removal representing 36% of the reasons. This figure is lower compared with findings of the studies in Australia and Scotland for which bleeding pattern dissatisfaction was the commonest reason for premature removal accounting for 50.6% and 62% of the reasons, respectively [9-13]. Report from study in Southern Nigeria identified heavy menstrual bleeding as a reason for premature removal in 28.6% of the study participants. On the other hand the figure is higher than that of other regions such as United States, Europe and Asia. Discontinuation rates owing to heavy/prolonged menstrual bleeding were approximately 14% in United States and Europe, but only 4% in Southeast Asia, Chile and Russia [9-16]."