November 3, 2017 –San Diego, CA. Three powerful Congress members are joining forces to question why the F.D.A. has taken so long and dropped the ball on Bayer’s Essure birth control device regulations.
On October 30, 2017 the three joined together and authored a letter to the Commissioner of the FSA, Dr. Scott Gottlieb, M.D. Here is the actual letter; also link at the bottom to the online PDF file is available.
The main issues they are asking the F.D.A. on Essure about are:
- What is the actually doing to get Bayer to comply for recruiting patients for the study plan.
- When will the official number of patients enrolled be released?
- How many sites are actively recruiting patients?
- How is Bayer making sure that participants are informed about the black box warning?
- Will participants be tested for nickel allergy before enrolling and will the nickel contradiction be added to the current labeling for Essure?
We applaud these members of Congress and hope that by joining forces the FDA will wake up and ban this terrible birth control device which continues to hurt women in the U.S.
Bayer has halted sales of Essure in most European countries, yet still offers it in the U.S.
What are the side effects of Essure?
Essure has been linked to a multitude of adverse side effects by thousands of women who had the metal coils inserted. Side effects can range from mild to severe; some may even be life-threatening. The following symptoms and side effects have been reported by women who had Essure inserted:
- Heavy or irregular menstrual cycles
- Fatigue
- Weight gain or loss
- Allergies to nickel
- Pregnancy, ectopic pregnancy
- Device migration
- Perforation of organs
- Broken or missing coils
- Chronic pelvic pain
- Pain – lower back, hip, joint, chest, leg, neck, spine
- Hair loss
- Hair growth in new places
- Headaches or migraines
- Nausea, vomiting
- Malaise, general feeling of illness or discomfort
- Severe bloating
- Cramping
- Endometriosis
- Fibroids
- Night sweats
- Loss of libido
- Bleeding/spotting after sex
- Painful intercourse (dyspareunia)
- Yeast infections
- Bacterial vaginosis
- Urinary tract infections (UTIs) or bladder infections
- Blood in urine
- Swelling, inflammation of cervix or vagina
- Itching, burning, stabbing pain at vaginal opening
- Breast pain, tenderness
- Constipation, gas, diarrhea
- Metallic taste in mouth
- Heartburn
- Mood swings
- Dizziness
- Anxiety
- Depression
- Tingling sensations
- Brain fog, forgetfulness
- Fainting/black out spells
- Blood clots
- Vitamin D or B12 deficiencies
- Anemia, iron deficiency
- Hives, rashes, skin irritation
- Acne
- Dental issues
- Insomnia
- Thyroid disease
- Swelling of legs, feet
- Muscle spasms
- Vision problems
- Excessive sweating
- Dry skin, hair or eyes
Source: https://delauro.house.gov/sites/delauro.house.gov/files/FDA-Essure-Letter-Congress.pdf
