MAUDE Adverse Event Report: HOLOGIC, INC. ADIANA PERMANENT CONTRACEPTION SYSTEM; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number A1000US

Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problems Abscess (1690); Arthritis (1723); Fatigue (1849); Hair Loss (1877); Headache (1880); Unspecified Infection (1930); Memory Loss/Impairment (1958); Convulsion/Seizure (4406); Syncope/Fainting (4411)

Event Type  Injury  

Manufacturer Narrative

According to the information provided in the medwatch notification mw5109621, the patient claims that the adiana device has become fragmented and the pieces of the device have begun to migrate through their body and have been expelled from the skin.The details of this event have been reviewed with a subject matter expert from research and development and it has been determined that it is not plausible that the symptoms described by the patient could be caused by the adiana device.The adiana is a permanent contraceptive device which is implanted in the patient to prevent pregnancy.The device is made up of silicone, and is comprised of a solid silicone core surrounded by porous silicone material.It is extremely unlikely for any material degradation or deformation to result in fragmentation or splinters which could then result in physical injury to anatomical structures.The patient has indicated that they have retained some samples for further testing.As of the date of this report there have been no samples returned to hologic for further analysis.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.If the sample is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure and a follow up report will be submitted to document any results.

Event Description

This event was reported to hologic by means of medwatch notification mw5109621, received on (b)(6) 2022.The adverse event was described in the report as: i have adiana.My gynecologist told me that was not the source of the reversed splinters that felt like i sat on fiberglass and i had small pieces poking out of the skin on my clitoris and continue to splinter and infect my whole body also causing me to have migraines and seizures, we know what else my families never had cancers.I lost my hair in 2015.I started having arthritis symptoms, fatigue, memory losses, then i started having seizures, i had blackouts, pieces removed from my chin abscess.I've had four surgeries due to adiana and finally had them removed.I could not get any help and my gynecologist to install them with no help either he had other patients that migrated so i think he did not want me to report before then as being.No one believes what it was, so i was even "baker" acted.Everyone thought i was seeing things.I couldn't get anyone to help me and doctors were telling me that's not what it was.I could feel it inside of me as it moved to the uterus.It was not supposed to be dangling down.I lived with this problem of the migrating 80 on a birth control device for over four years because no one believes me, it has scarred my life and my face and my entire body.I just got them out a couple of months ago, but they're still pieces floating around and coming out.I was wondering if there's anyway i could have them tested pieces that i have saved, so they can prove that it is what i said it was.

• Brand Name: ADIANA PERMANENT CONTRACEPTION SYSTEM
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC SURGICAL PRODUCTS COSTA RICA S.R.L.; 562 parkway; coyol free zone building b24; san jose, alajuela 20102 ; CS 20102
• Manufacturer Contact: david ramsay ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 14884392
• MDR Text Key: 295110116
• Report Number: 1222780-2022-00175
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/30/2022

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: Health Professional
• Device Model Number: A1000US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Other
• Patient Sex: Female