Implanon Class Action Highlights Problems with Implantable Birth ControlFeb 16, 2017
Ten years ago the U.S. Food and Drug Administration (FDA) gave approval to the Implanon birth control device, despite concerns raised about similar implantable birth control devices.
Implanon and similar implantable birth control devices are generally effective in preventing pregnancy for three or more years, but many women have experienced problems with these implants. The devices have migrated from the implant site and have been difficult to remove. Merck faces a class action lawsuit over device migration and difficulty in removal.
Parker Waichman LLP closely monitors information about implantable birth control device side effects and complications. The firm can answer women's questions about filing an Implanon lawsuit.
Implanon Long-Term Birth Control
Implanon, made by Merck subsidiary Organon, is a long-term, low-maintenance birth control method. The device prevents unwanted pregnancy for up to three years while freeing the user from having to remember to take a daily pill or change a birth control patch.
Implanon is a flexible plastic rod about the size of a matchstick that is inserted under the skin of a woman's upper arm. The rod releases a low, steady dose of etonogestrel, a form of the hormone progesterone. The hormone thickens cervical mucus to help prevent sperm from reaching the egg and thins the lining of the uterus (endometrium), making it unreceptive to implantation of an embryo.
Implanon is inserted in a procedure in a doctor's office. The skin is numbed before insertion. Once Implanon is inserted, the doctor must check to be sure the implant is in place by feeling for it. After insertion, the area must remain bandaged for three to five days while the site heals.
The implant is intended to be removable if the woman decides she would like to become pregnant or no longer wants this method of birth control. According to the package insert, the hormone level in the woman's blood decreases quickly after Implanon is removed and some women can become pregnant as soon as one week after Implanon is removed.
If at any time after insertion, Implanon cannot be felt under the skin, a health care provider should locate and remove the device.
A number of women have alleged that the doctor had difficulty locating and extracting the Implanon rod at the end of its life cycle. In some instances, the device had migrated from the original insertion site. The Implanon device has sometimes been found far from the original insertion point, for instance in a blood vessel in the lung. Then the implant has migrated to the pulmonary artery or moved deep into tissue, a surgical procedure may be needed for removal, the FDA says. In rare instances, the device cannot be located and the woman is at risk for side effects, including vascular damage.
Women have reported allergic reactions, skin and tissue reactions, and some women have become pregnant with Implanon in place. A Bangor, Maine woman who became pregnant 18 months after having Implanon inserted has filed a wrongful birth lawsuit over the failure of Implanon to prevent pregnancy.
To improve the ability to locate Implanon, Organon brought out Implanon NXT and Nexplanon, which contain barium sulfate in the core of the device. Barium sulfate shows up on X-rays, and can aid in locating a device that has migrated.
In March 2016, the FDA ordered Merck to make label changes to Implanon to advise women and health care providers of possible complications with Implanon insertion and removal. But the FDA did not order the device to be removed from the market.
Problems with this type of implantable birth control device are not new. A research paper from 1994 described difficulty in locating, and removing all six capsules of the now-withdrawn Norplant birth control implant. When a woman requested removal of Norplant, the doctor was able to remove five of the six capsules, but it took four attempts to locate and remove the sixth Norplant capsule. The manufacturer, Wyeth, withdrew Norplant from the market in 2000, reportedly while facing numerous lawsuits over the product. When the FDA gave approval for Implanon six years later, there was no mention of the possibility of device migration. Such an advisory did not come until the March 2016 warning.
Legal Help for Women Harmed by Implanon
If you or a woman you know has experienced migration, difficulty in removal, or other side effects from the Implanon birth control implant, the attorneys at Parker Waichman LLP can help evaluate your legal rights. For a free, no obligation case evaluation, fill out the online contact form or call 1-800-YOURLAWYER (1-800-968-7529).