Rep. Fitzpatrick: Permanent Birth Control Device Linked To More Fetal Deaths Than Previously Reported
In a conference call with reporters, Rep. Mike Fitzpatrick, D-Pa., alleged this harm and other adverse events. He also charged that physicians who performed the procedure received illegal kickbacks.
Modern Healthcare:
FDA Grossly Underestimated Harm From Permanent Contraceptive Essure, Lawmaker Says
A U.S. congressman and a patient advocacy group said Wednesday a permanent contraception device linked to thousands of adverse events has led to far more fetal deaths than previously reported and that doctors performing the procedure received illegal kickbacks. Rep. Mike Fitzpatrick (R-Pa.) said in a conference call with reporters that he found it troubling that the U.S. Food and Drug Administration did not act on the complaints it had received until thousands of women who said they had been harmed by the device started publicly announcing their concerns. (Muchmore, 2/17)
WXYZ:
U.S. Rep Alleges Hundreds Of Fetal Deaths Linked To Essure, Kickbacks Related To Birth Control Device
A US Congressman says a controversial birth control device has caused hundreds more fetal deaths than the FDA has publicly reported. For years, the 7 Investigators have been exposing the health problems that women say Essure has caused, many of them telling us the device has ruined their lives. (Catallo, 2/17)
In other FDA news —
The New York Times:
F.D.A. Deals Setback To Catalyst In Race For Drug Approval
A Florida company involved in an unusual race for approval of a drug that treats a rare neuromuscular condition had a setback on Wednesday, after federal regulators said they needed more information before deciding whether to approve it. The drug treats a disease called Lambert-Eaton myasthenic syndrome, and for years was given away by a New Jersey company, Jacobus Pharmaceutical, under an obscure federal drug provision. It never had formal approval from the Food and Drug Administration. (Tavernise, 2/17)
