MAUDE Adverse Event Report: CONCEPTUS / BAYER HEALTHCARE, LLC ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Inflammation (1932); Irritation (1941); Pain (1994); Rash (2033); Swelling (2091); Cramp(s) (2193); Discomfort (2330); Toxicity (2333); Weight Changes (2607); Heavier Menses (2666)

Event Date 07/01/2006

Event Type  Injury  

Event Description

After essure was implanted in 2006, i experienced heavy bleeding, as well as, sharp pain and cramping.I still have sharp pain and cramping.I learned after the surgery that the coils were made of nickel.I am allergic to nickel.I have had a very uncomfortable rash all over my body, when biopsied, it was revealed that it was a chronic inflammation (allergy related).I have to use a topical steroid to ease discomfort, but have no relief.My hands are so irritated and swollen that i cannot use them for basic self care.My face has an unsightly rash as well.In 2012, i began bleeding excessively with little relief.I learned that a tumor had developed.I also became anemic.I had to stop teaching choreography and dance, which i loved, due to the pain and bleeding.I had to have both embolization and ablation surgery.The bleeding stopped, however, i still have sharp pain and cramping.I have also had bloating, and weight fluctuations.It has now been 12 years since i had the essure implanted and it has been recommended by my physician that i consider a hysterectomy to remove the coils due to the nickel allergy.The physician should have been required to make sure to inform his pts about the nickel in the coils before he implanted them in my body.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): CONCEPTUS / BAYER HEALTHCARE, LLC
• MDR Report Key: 7714329
• MDR Text Key: 114993993
• Report Number: MW5078550
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 70