Pharmaceutical

Rep. Fitzpatrick to announce medical device reform bills

morcellator Rep Mike Fitzpatrick wikimedia 139x210 Rep. Fitzpatrick to announce medical device reform billsThis week, Rep. Mike Fitzpatrick (R-PA) along with Rep. Louise Slaughter (D-NY) will announce a package of bills aimed at strengthening the Food and Drug Administration’s (FDA) medical device review process and increasing the accountability for dangerous products. They will be joined by women and families affected by medical devices including the permanent birth control method Essure and the laparoscopic hysterectomy device power morcellator. Speakers will share the emotional effects they say they experienced as a result of these allegedly failed medical devices, and their fight for justice.

Fitzpatrick has been the leading voice in Congress calling for medical device approval and review reform, in particular for devices he says harm women. According to a statement released by his office: “Essure has harmed more than 25,000 women who have reported symptoms including extreme pelvic and abdominal pain, migraines, autoimmune reactions, loss of teeth and hair, and the coil damaging the uterus and other organs in the abdominal cavity. Last year, Fitzpatrick introduced the E-Free Act to remove the permanent sterilization device Essure from the market.”

The statement adds: “Power Morcellators have been spreading an undetectable fibroid cancer throughout the body, like shrapnel, for decades – taking Stage 1 cancers immediately to Stage 4. For hundreds, if not thousands of women, what was supposed to be a routine procedure ended with a death sentence. Last year, Fitzpatrick successfully commissioned a GAO investigation into FDA’s approval of this device and the failure of the reporting system to catch this unsafe device.”

Source: Legal Reader