Pharmaceutical

FDA approves Bayer Inserter for Skyla, Mirena IUDs

mirena IUD 435x290 FDA approves Bayer Inserter for Skyla, Mirena IUDsThe Food and Drug Administration (FDA) has approved a new inserter device by Bayer HealthCare Pharmaceuticals designed to aid in the insertion of the company’s own intrauterine devices, the Mirena IUD and Skyla IUD.

Both the Mirena and Skyla IUDs are flexible, T-shaped devices that are inserted into the cervix where they release the hormone levonorgestrel. Skyla prevents pregnancy for up to thee years, while Mirena is considered effective for up to five years. Mirena is also indicated to treat heavy bleeding in women who choose to use an IUD as their method of contraception. Mirena is designed for women who have already had a child.

The Bayer inserter features a thin, flexible insertion tube. The inserter is preloaded with a small, founded flexible T-body and enables single-handed loading of the IUD. The diameter of the insertion tube for Skyla is 3.8 mm and 4.4 for Mirena, according to a company press release.

The device is designed to aid in the insertion of the IUD. In some cases, the devices have migrated from their intended position in the cervix and perforated tissue and organs. In come cases, hospitalization and surgery were required. Bayer does not address whether the inserter can reduce the risk for adverse effects such as migration or perforation.

Bayer currently faces lawsuits from women who claim they were injured by the Mirena IUD. Attorneys with Beasley Allen Law Firm are currently investigating cases and are available for consultation.

Source: True Blue Tribune