Essure lawsuits filed against Bayer HealthCare Pharmaceuticals have come into the focus as the FDA gets ready to meet this week to examine complaints that the Essure birth control device causes complications such as perforation of the uterus or fallopian tubes, and chronic pain.
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The Arentz Law Group is offering free legal consultations to all women who have undergone Essure removal surgery or who have suffered negative health effects due to Essure Permanent Birth Control Implants. The implant consists of two tiny, metallic coils that are inserted into the fallopian tubes, where they trigger the growth of scar tissue that eventually blocks sperm from reaching eggs. Yet since the device became available in 2002, the FDA has received about 5,000 complaints from women with the device including chronic pain, heavy or irregular periods, headaches, fatigue, allergic reactions, and weight gain.
“The FDA takes reports of safety concerns seriously”, the agency said in a statement.
“Within 12 months of placement I developed pain throughout my entire body”, said Kim Hudak, who had was part of the clinical trials for Essure.
Some women said the device has worked well for them. However, the past couple of years have seen the FDA receiving a host of complaints from women using the device. “It’s severe, debilitating pain and bleeding that will knock you down”, says Dykeman, who received the device in 2010 and had it removed in a hysterectomy in 2013.
US wellbeing specialists will audit the potential dangers of Bayer AG’s lasting prophylactic gadget, Essure, on Thursday in light of developing grumblings over conceivable reactions, and consider whether its utilization ought to be confined. The FDA also said that a number of limitations had to be taken into account while they were reviewing the data.
German drug company Bayer says that the label is consistent with the actual risks posed by the product.
One gynecologist, Dr. Sebastiaan Veersema, Antonius Hospital Nieuwegein in the Netherlands, who was an early adopter of Essure and has implanted the contraceptive device in to nearly 1,400 women, now believes it requires further study.
“There’s a need for safe and effective options for permanent birth control for women who have decided they’ve completed their families and that’s what Essure can provide for appropriate patients”. Dr. Raegan McDonald-Mosley, the chief medical officer for Planned Parenthood, said the organization had conducted an internal analysis that found very few problems.
In accordance with the company: “FDA has been unable to find any vital scientific literature which particularly evaluated complications following Essure remedy”.
“Now they’re gone and I feel like a totally different woman”, said Gay. Now those women have a voice with the FDA.
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“Clearly, the data for Essure shows the benefits outweigh the risks”, said Edio Zampaglione, Bayer’s Vice President of Medical Affairs for Women’s Health. That’s the main problem right now – the FDA can’t be sure whether women are experiencing these side effects as a result of Essure alone.
