MAUDE Adverse Event Report: CONCEPTUS, INC ESSURE DEVICE, TUBAL CONTRACEPTIVE

Event Date 06/01/2012

Event Type  Injury  

Event Description

Three months after implantation of essure, x-ray was done and showed that it was a success. However, immediately after essure was implanted, pt had severe back pains, severe bleeding, cramping, dizziness, fainting and sharp pains, for 10 months up until device was explanted on (b)(6) 2012. Pt also got pregnant in (b)(6) 2012, inspite of using essure. When sonogram was done, baby had severe birth defects, and neurological issues that she had to terminate the pregnancy. Diagnosis of baby is exposure to carcinogen, which is the nickel in the essure, per pt and the body's reaction to it. Per pt, she hasn't had this with her other children and the only exposure she had was the essure still implanted in her. On (b)(6) 2012, pt had a total hysterectomy done, to remove the essure. Pt alleged that the side effects of getting pregnant and birth defects, the need for a nickel allergy test is not disclosed in the pamphlet/insert. Pt disclosed her md as dr (b)(6).

Event Description

Additional info received from rptr (b)(6) 2012: i underwent the essure "permanent birth control" procedure in (b)(6) 2012. Three months after, i had an x-ray confirming the procedure was successful as required by conceptus. Immediately after placement of the devices, i began having health issues (headaches, excessive tiredness, fainting, cramping) as if in labor, horrible periods, back pain, stabbing pains, etc. (b)(6) months after the procedure, i became pregnant. My doctor notified essure and sent them my confirmation results. They were supposed to get in touch with me, but never have. I was told by my doctor that the rep told him that in 10 years, i was the 1st to get pregnant after confirmation test. I have since found out that this is not the truth. Furthermore, the essure devices i received contain nickel, which is a teratogen. Nickel can cause allergic reactions in the body as well as birth defects. At (b)(6) months, a sonogram confirmed the worst, that the baby had severe health issues/defects. We had to terminate. When researching the diagnoses, i learned that the issue has been linked to exposure to teratogens. I have since come into contact with hundreds of women who all have the same health issues since having the essure procedure, and/or have also gotten pregnant. Most pregnancies ended in miscarriages. Many of the women have had the devices migrate causing serious health issues. They are being told by doctors to leave devices alone, they are harmless. The one thing we all have in common is that we were not told of the serious side effects, and feel that conceptus is being dishonest in reporting failures/issues. The sales reps are certainly not telling the doctors of the issues, because we are not being informed by the doctors. Once we have the devices in us, the only option for recovery is a hysterectomy. After doing the hysterectomy, our health issues mysteriously vanish. This product is harmful, is responsible for deaths of babies and destroying women's health. It needs to be recalled.

• Brand Name: ESSURE
• Type of Device: DEVICE, TUBAL CONTRACEPTIVE
• Manufacturer (Section D): CONCEPTUS, INC; 331 east evelyn ave; mountain view CA 94041
• MDR Report Key: 2700733
• Report Number: MW5026500
• Device Sequence Number: 1
• Product Code: HHS
• Report Source: Voluntary
• Reporter Occupation: PATIENT
• Type of Report: Initial,Followup
• Report Date: 08/18/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/14/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Is this a Reprocessed and Reused Single-Use Device?: No

Patient TREATMENT DATA

Date Received: 08/14/2012 Patient Sequence Number: 1