WHO:

• Congressman Mike Fitzpatrick (PA-8)
• Families impacted by dangerous medical devices like Essure
• Patient safety advocates

WHAT:

• Rep. Fitzpatrick will join women and families affected by dangerous medical devices Essure and laparoscopic power morcellators to announce package of bills aimed at strengthening the FDA’s medical device review process and increasing accountability for dangerous products. Speakers will share the emotional effects of these failed devices and their fight for justice.

WHEN:

• Wednesday, June 8 @ 1pm

WHERE:

• House Triangle @ U.S. Capitol Building

RSVP:            

• To confirm coverage or request more information, contact Aaron Clark at aaron.clark@mail.house.gov.Fitzpatrick and individuals will be available for calls with press following the event – Please contactaaron.clark@mail.house.gov for more information.

BACK-GROUND:

• Fitzpatrick has been the leading voice in Congress calling for medical device approval and review reform. Most recently, he has called for an Energy & Commerce Committee hearing on the FDA’s broken process.

• 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.

• 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.