Pharmaceutical

Representative introduces bills to protect women from dangerous medical devices

morcellator Rep Mike Fitzpatrick wikimedia 139x210 Representative introduces bills to protect women from dangerous medical devicesA bill known as Ariel Grace’s Law, designed to help women who claim they were injured by the permanent birth control device Essure fight back against the manufacturer of the device, was introduced on the House floor this week. This happened just as a second bill, called the Medical Device Guardians Act, was filed, giving physicians a more effective way of reporting problems with medical devices to the Food and Drug Administration (FDA).

Both bills were introduced by Rep. Mike Fitzpatrick, who is helping raise awareness of the need for closer scrutiny of medical devices. He has taken up the fight for women who claim they were injured by Essure, as well as those who have suffered cancer spread after undergoing a hysterectomy or uterine fibroid removal surgery using a surgical tool known as a power morcellator.

Essure, made by Bayer, is the only FDA-approved nonsurgical permanent birth control method on the market. It consists of two nickel alloy coils that are implanted in the fallopian tubes where they work with the body to build up a scar tissue barrier to prevent the sperm from reaching the egg. The implants have been linked to allergic reactions, autoimmune reactions, infections, chronic pain and bleeding. In some cases, the coils can migrate and puncture the fallopian tubes or uterine wall.

After mounting complaints from consumers, the FDA launched an investigation and, in February, fell short of banning the device and instead recommended that a black box warning be placed on the label of Essure to warn of complications.

Power morcellators, made by various manufacturers, are surgical tools fitted with a tube-like blade that shreds uterine fibroids or entire uteruses within the body and removes the tissue through a small incision in the abdomen. Morcellation has been linked to spread undected uterine cancer, immediately upstaging the disease and worsening the odds of survival.

In 2014, the FDA placed a black box warning on power morcellators and recommended the procedure not be used on most women due to the risk of cancer spread.

Source: KXAN