MOONCUP® / MCUK®
Report
- Report Number
- 3009117944-2017-00003
- Event Type
- Injury
- Date Received
- December 11, 2017
- Date of Event
- June 1, 2010
- Report Date
- December 11, 2017
- Manufacturer
- MOONCUP LTD
- Product Code
- HHE
- PMA / PMN Number
- K060852
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
SILICONE ALLERGY LITERATURE REVIEW. AN EXTENSIVE SEARCH FOR DATA AND INFORMATION REGARDING ALLERGIC RESPONSE TO MEDICAL GRADE SILICONE INDICATES THAT THE INCIDENCE IS RARE. "SILICONES, ONE OF THE MOST THOROUGHLY TESTED AND WIDELY USED GROUPS OF BIOMATERIALS, ARE WELL KNOWN FOR THEIR INTRINSIC BIOCOMPATIBILITY AND BIODURABILITY. THESE KEY CHARACTERISTICS HAVE BEEN ATTRIBUTED TO THE MATERIALS' INHERENT CHEMICAL STABILITY" (10). MEDICAL GRADE SILICONE IS USED EXTENSIVELY WITHIN HEALTHCARE (1). EXAMPLES OF ITS APPLICATIONS INCLUDE CATHETER TUBING, PACEMAKERS, VENTRICULOPERITONEAL SHUNTS, COCHLEAR IMPLANTS, INTRAVENOUS MEDICATION GIVING SETS, RESPIRATORY MASKS, GASTROSTOMY FEEDING TUBES, CONTRACEPTIVE DIAPHRAGMS AND MENSTRUAL CUPS TO NAME BUT A FEW. IT IS ALSO USED AS A COATING OR LUBRICATION FOR MOST HYPODERMIC NEEDLES, SYRINGES AND OTHER BLOOD-COLLECTING APPARATUS. ALLERGY: "A REACTION PRODUCED BY THE BODY'S IMMUNE SYSTEM WHEN EXPOSED TO A NORMALLY HARMLESS SUBSTANCE. IT IS NOT CLEAR WHY THIS HAPPENS, BUT MOST PEOPLE AFFECTED HAVE A FAMILY HISTORY OF ALLERGIES OR HAVE CLOSELY RELATED CONDITIONS SUCH AS ASTHMA OR ECZEMA. THE NUMBER OF PEOPLE WITH ALLERGIES IS INCREASING EVERY YEAR. THE REASONS FOR THIS ARE NOT UNDERSTOOD, BUT ONE OF THE MAIN THEORIES IS IT'S THE RESULT OF LIVING IN A CLEANER, GERM FREE ENVIRONMENT, WHICH REDUCES THE NUMBER OF GERMS OUR IMMUNE SYSTEM HAS TO DEAL WITH. IT'S THOUGHT THAT THIS MAY CAUSE IT TO OVERREACT WHEN IT COMES INTO CONTACT WITH HARMLESS SUBSTANCES." (19). MOONCUP MENSTRUAL CUP: INTENDED USE OF THE DEVICE THE MOONCUP® IS A REUSABLE MENSTRUAL CUP PLACED IN THE VAGINA TO COLLECT BLOOD AND CELLULAR DEBRIS DURING MENSTRUATION. MENSTRUAL CUPS ARE A COMMERCIALLY AVAILABLE METHOD OF SANITARY PROTECTION PURCHASED BY THE USER AND NOT REQUIRING ANY SPECIALIST TRAINING. THE MOONCUP IS SUPPLIED NON-STERILE, AND IS INTENDED TO BE REMOVED AND EMPTIED AT LEAST EVERY EIGHT HOURS AND REINSERTED INTO THE VAGINA. BETWEEN PERIODS THE DEVICE IS TO BE CLEANED AND STORED BY THE USER. MOONCUP MENSTRUAL CUP: MANUFACTURING ENVIRONMENT : FORMAL CLEAN ROOM STANDARDS ARE NOT DEMANDED FOR THE MANUFACTURE OF A PRODUCT THAT IS CLEANED BEFORE USE AND INTENDED FOR INSERTION INTO THE VAGINA. HOWEVER, THE MOULDING AND FINAL PROCESSING OF THE MOONCUP MENSTRUAL CUP IS CARRIED OUT IN A ROOM WITH A CONTROLLED ENVIRONMENT (ISO CLASS 7) TO MINIMIZE UNWANTED CONTAMINATION OF THE SILICONE MATERIAL BEFORE USE. THIS ENVIRONMENT AND PERSONNEL WHOM ENTER ARE CONTROLLED UNDER ISO 13485 CERTIFICATED QUALITY MANAGEMENT SYSTEM. MOONCUP LTD COMPLY WITH REGULATORY REQUIREMENTS OF THE F.D.A 21 CFR PART 820, AND BS EN ISO 13485:2012 FOR THE MANUFACTURE AND DISTRIBUTION OF MEDICAL DEVICES. THE MAJORITY OF PUBLISHED LITERATURE EXPLORING A POTENTIAL ALLERGIC REACTION TO SILICONE TAKES THE FORM OF PATIENT CASE REPORTS INCLUDING THE FOLLOWING: CASES OF SILICONE ALLERGY WITH PATIENTS FITTED WITH VENTRICULOPERITONEAL SHUNTS HAVE BEEN REPORTED (2, 3,4, 5). REPORTED REACTIONS WERE VARIABLE AND INCLUDED SYSTEMIC REACTIONS (EG. DIZZINESS AND DIFFUSE ABDOMINAL PAIN) AND LOCALISED REACTIONS (SKIN BREAKDOWN, FUNGATING GRANULOMAS). ALLERGY TO SILICONE HAS BEEN IDENTIFIED AS A RARE BUT POSSIBLE CAUSE OF COCHLEAR IMPLANT EXTRUSION (6, 7). IN ONE CASE (6) IT WAS FOUND THAT A REACTION OCCURRED SPECIFICALLY TO SILICONE LSR-30 BUT THE REACTION DID NOT OCCUR TO SILICONE LSR-70. THE AUTHORS WERE UNSURE OF THE REASONING FOR THIS. CASES OF SILICONE ALLERGY OCCURRING IN INDIVIDUALS FITTED WITH PACEMAKERS WITH COATINGS CONTAINING SILICONE COMPONENTS HAVE BEEN REPORTED (8). IN THIS CASE, THE SYMPTOMS PRESENTED AS RECURRENT WOUND COMPLICATIONS. IT IS WORTH NOTING THAT ALL OF THE ABOVE CASES RELATE TO IMPLANTABLE DEVICES USED IN MEDICAL SITUATIONS. IMPLANT: "IMPLANT IS A DEVICE THAT IS PLACED INTO A SURGICALLY OR NATURALLY FORMED CAVITY OF THE HUMAN BODY AND IS INTENDED TO REMAIN THERE FOR A PERIOD OF 30 DAYS OR MORE. IN ORDER TO PROTECT PUBLIC HEALTH, FDA MAY DETERMINE THAT DEVICES PLACED IN SUBJECTS FOR SHORTER PERIODS ARE ALSO IMPLANTS." (20) BIOCHEMICAL TESTING TO DETERMINE THE EXISTENCE AND UNDERSTAND THE NATURE OF POTENTIAL IMMUNOLOGICAL RESPONSE TO SILICONE HAS PRODUCED MIXED AND INCONCLUSIVE RESULTS. THIS HAS LARGELY BEEN DUE TO SIGNIFICANT TECHNICAL PROBLEMS IN CONSTRUCTING A RELIABLE TEST ASSAY TO IDENTIFY ANTI-SILICONE ANTIBODIES (9). THE BULK OF STUDIES REGARDING TEST DEVELOPMENT HAS FOCUSED ON PATIENTS WHO HAVE HAD (OR PREVIOUSLY HAD) SILICONE BREAST IMPLANTS. SOME STUDIES HAVE SUGGESTED THAT ANTI-SILICONE ANTIBODIES (MAINLY IGG) ARE MEASURABLY PRESENT IN THIS PATIENT GROUP (11, 12) AS WELL AS IN PATIENTS FITTED WITH VENTRICULOPERITONEAL SHUNTS (3). HOWEVER, THE FINDINGS HAVE REMAINED CONTROVERSIAL AND INCONCLUSIVE WITH OTHER STUDIES REPORTING A LOW LIKELIHOOD OF ANTI-SILICONE ANTIBODIES (13, 14, 17) OR THAT PROTEINS (INCLUDING ANTIBODY PROTEINS) BIND NON-SPECIFICALLY TO SILICONE (15, 16). ADDITIONALLY, ATTEMPTS TO REPLICATE THE TEST FINDINGS OF STUDIES SUGGESTING A POSITIVE OCCURRENCE OF ANTI-SILICONE ANTIBODIES HAVE HIGHLIGHTED DIFFICULTIES AND SHORTCOMINGS IN THE RELIABILITY AND THUS VALIDITY OF TESTING METHODS (16, 18). AS A RELIABLE ASSAY TO IDENTIFY ANTI-SILICONE ANTIBODIES DOES NOT APPEAR TO BE AVAILABLE CURRENTLY, THE EXISTENCE OF ANTI-SILICONE ANTIBODIES REMAINS TO DATE UNPROVEN AND DRAWING CONCLUSIONS REGARDING ITS INCIDENCE REMAINS UNCLEAR. SOME STUDIES PRESENTED IN THIS LITERATURE REVIEW EXPLAIN AND DISCUSS SPECIFIC CASE EXAMPLES OF POTENTIAL MEDICAL GRADE SILICONE ALLERGY OR REACTION WHEN USED BY THE MEDICAL PROFESSION FOR PARTICULAR INDIVIDUALS AS EITHER A DEVICE OR PIECE OF EQUIPMENT DURING MEDICAL PROCEDURES. SO FAR, NO STUDIES, OR PUBLICATIONS WERE FOUND THAT REPORT, DEMONSTRATE OR CORRELATE SILICONE ALLERGY WITH MENSTRUAL CUP USE. OTHER THAN IN EXTREMELY RARE CASES SUCH AS THE CASE PRESENTED IN OUR REPORT, THERE IS CURRENTLY A LACK OF EVIDENCE TO SUPPORT THIS ASSOCIATION. IT IS ALSO IMPORTANT TO NOTE THAT THE EXACT FORMULATIONS OF SILICONE REVIEWED IN THE LITERATURE ABOVE VARY IN TYPE, WHICH CAN CREATE INCONSISTENCIES WHEN EVALUATING RESULTS AND CONCLUSIONS. AT THE PRESENT TIME, THE MEDICAL PROFESSION AT LARGE CONTINUES TO USE MEDICAL DEVICES AND EQUIPMENT MANUFACTURED WITH MEDICAL GRADE SILICONE INDICATING HOW RARE THIS TYPE OF ALLERGIC RESPONSE IS. HOWEVER, IT IS CLEARLY IMPORTANT THAT THE REPORTING OF SUCH INCIDENCES CONTINUES TO BE DOCUMENTED TO IDENTIFY EMERGING TRENDS. TO DATE, THERE HAVE BEEN NO OTHER REPORTED CASES OF CONFIRMED MEDICAL GRADE SILICONE ALLERGY FROM MOONCUP® USERS TO MOONCUP LTD SINCE ITS INCEPTION IN 2002. THE PRODUCT LABELLING STATES THAT THE MOONCUP MENSTRUAL CUP IS MADE OF MEDICAL GRADE SILICONE. THE FOLLOWING CAUTIONARY NOTES ARE INCLUDED ON THE USAGE INSTRUCTIONS SUPPLIED WITH EACH MOONCUP MENSTRUAL CUP SOLD: REMOVE YOUR MOONCUP AND CONTACT YOUR DOCTOR IF YOU EXPERIENCE SYMPTOMS SUCH AS GENERAL PAIN, BURNING, IRRITATION, INFLAMMATION IN THE GENITAL AREA OR DISCOMFORT DURING URINATION. IF YOU SUSPECT YOU HAVE A GYNAECOLOGICAL CONDITION CONSULT YOUR DOCTOR BEFORE YOU USE THE MOONCUP. REFERENCE LIST: CURTIS, J. AND COLAS, A. (2004) MEDICAL APPLICATIONS OF SILICONES. IN: BD RATNER ET AL, ED. BIOMATERIALS SCIENCE: AN INTRODUCTION TO MATERIALS IN MEDICINE. SECOND EDITION. ELSEVIER ACADEMIC PRESS, PP. 697-707, ARAKALI, S. AND FAJT, M. (2016). AN UNUSUAL CAUSE OF PERSISTENT ABDOMINAL PAIN. ANNALS OF ALLERGY, ASTHMA AND IMMUNOLOGY . 117(5)PP:S116. GOLDBLUM, RM. PELLEY, RP. O'DONELL, AA. PYRON, D. HEGGERS, JP. (1992) ANTIBODIES TO SILICONE ELASTOMERS AND REACTIONS TO VENTRICULOPERITONEAL SHUNTS. LANCET. AUG 29;340(8818)PP: 510-3. ALVIS-MIRANDA, H., ALCALA-CERRA, G., CASTELLAR-LEONES, SM., ESCORCIA, HF., MOSCOTE-SALAZAR, LR. (2013) LATEX AND SILICON ALLERGY RELATED TO CEREBROSPINAL SHUNT HARDWARE. ROMANIAN NEUROSURGERY. XX1, PP:106-115. JIMENEZ, DF., KEATING, R. AND GOODRICH, JT. (1994) SILICONE ALLERGY IN VENTRICULOPERITONEAL SHUNTS. CHILDS NERVOUS SYSTEM. JAN;10(1), PP:59-63. PURI, S . DORNHOFFER, J. AND NORTH, PE. (2005) CONTACT DERMATITIS TO SILICONE AFTER COCHLEAR IMPLANTATION. THE LARYNGOSCOPE ISSUE: VOLUME 115(10), PP: 1760-1762. KUNDA, LD., STIDHAM, KR., INSERRA, MM., ROLAND, PETER S., FRANKLIN, D. AND ROBERSON, JB. (2006) SILICONE ALLERGY: A NEW CAUSE FOR COCHLEAR IMPLANT EXTRUSION AND ITS MANAGEMENT. OTOLOGY & NEUROTOLOGY ISSUE: VOLUME 27(8), PP: 1078-1082 OPREA, ML., SCHNÖRING, H., SACHWEH, JS., OTT, H., BIERTZ, J. AND VAZQUEZ-JIMENEZ, JF. (2009) ALLERGY TO PACEMAKER SILICONE COMPOUNDS: RECOGNITION AND SURGICAL MANAGEMENT. ANNALS OF THORACIC SURGERY. APR; 87(4) PP:1275-7. BONDURANT, S., ERNSTER, V. AND HERDMAN, R. EDITORS. (1999) SAFETY OF SILICONE BREAST IMPLANTS. INSTITUTE OF MEDICINE (US) COMMITTEE ON THE SAFETY OF SILICONE BREAST IMPLANTS; WASHINGTON (DC): NATIONAL ACADEMIES PRESS (US). CURTIS J. AND KLYKEN, P. (2008) A COMPARATIVE ASSESSMENT OF THREE COMMON CATHETER MATERIALS. DOW CORNING CORPORATION, USA. WOLF, LE., LAPPÉ, M., PETERSON, RD. AND EZRAILSON, EG. (1993) HUMAN IMMUNE RESPONSE TO POLYDIMETHYLSILOXANE (SILICONE): SCREENING STUDIES IN A BREAST IMPLANT POPULATION. FASEB J. OCT;7. PP:1265-1268. ROSE, NR., LANDAVERE, M. AND KUPPERS, RC. (1996) SILICONE BINDING IMMUNOGLOBULINS IN HUMAN SERA. CURRENT TOPICS IN IMMUNOLOGY AND MICROBIOLOGY.PP:210:269-282. WHITE, KL. AND KLYKKEN, PC. (1998) THE NON-SPECIFIC BINDING OF IMMUNOGLOBULINS TO SILICONE IMPLANT MATERIALS: THE LACK OF A DETECTABLE SILICONE SPECIFIC ANTI-BODY. IMMUNOLOGICAL INVESTIGATIONS. 27 PP: 221-235. KLYKKEN, P., COLAS, A. AND THOMAS, X. (2008) ANTISILICONE ANTIBODIES ARE BIOLOGICALLY UNLIKELY. CLINICAL RHEUMATOLOGY 27, PP:1077-1078. OLIVER, DW., WALKER, MS., WALTERS AE., CHATRATH, P. AND LAMBERTY, BG. (2000) ANTI-SILICONE ANTIBODIES AND SILICONE CONTAINING BREAST IMPLANTS. BRITISH JOURNAL OF PLASTIC SURGERY, 53, PP: 410-414. GOLDBLUM, RM., PYRON, D., AND SHENOY, M. (1995) MODULATION OF IGG BINDING TO SILICONE BY HUMAN SERUM ALBUMIN FASEB J. 9:A1029. DEWAN, PA., ASHWOOD, PJ., ROWAN-KELLY, B., FERRANTE, A. AND Z. MCCALLUM (2003) THE DETECTION OF IGG ANTIBODIES TO SILICONE . PEDIATRIC SURGERY INTERNTIONAL .19, PP:20-24. ROSENAU, B., SCHNEEBAUN, AB. AND SCHUR, PH. (1996).THE DEVELOPMENT OF AN ELISA METHOD FOR THE DETECTION OF "ANTIBODIES" TO SILICONE. IN: POTTER M., ROSE N.R. (EDS) IMMUNOLOGY OF SILICONES. CURRENT TOPICS IN MICROBIOLOGY AND IMMUNOLOGY, VOL 210. SPRINGER, BERLIN, HEIDELBERG. NHS CHOICES (2016). ALLERGIES. [ONLINE]. AVAILABLE AT: HTTPS://WWW.NHS.UK/CONDITIONS/ALLERGIES/ [ACCESSED 08.12.2017]. US FOOD AND DRUG ADMINISTRATION (2017). IDE DEFINITIONS AND ACRONYMS [ONLINE]. AVAILABLE AT: HTTPS://WWW.FDA.GOV/MEDICALDEVICES/DEVICEREGULATIONANDGUIDANCE/HOWTOMARKETYOURDEVICE/INVESTIGATIONALDEVICEEXEMPTIONIDE/(B)(4).HTM [ACCESSED: 11/12/2017].
THE CUSTOMER REPORTED THAT FROM THE START OF USING THE MENSTRUAL CUP ABOUT 7 YEARS AGO, SHE FELT A LITTLE BIT OF DISCOMFORT THOUGH THOUGHT THIS WAS NORMAL. AFTER USING THE MENSTRUAL CUP FOR 3 TO 4 CYCLES, SHE STARTED TO FEEL PAIN AND SWELLING IN HER VAGINA. SHE DIDN'T KNOW WHAT WAS CAUSING THIS. UPON FEELING THIS AGGRAVATION, THE CUSTOMER DISCONTINUED USE OF THE MENSTRUAL CUP AND DISCARDED IT. SHE VISITED 5 DOCTORS AND ONE GYNAECOLOGIST, WHO DIDN'T KNOW WHAT WAS CAUSING THIS AND OFFERED NO DIAGNOSIS, SOLUTION OR TREATMENT. THE CUSTOMER DESCRIBED THE FOLLOWING SYMPTOMS: THE TISSUE OF HER VAGINA BEING SWOLLEN AND HURTING, PAIN UPON MAKING SHARP MOTIONS (WHILE WALKING OR CHANGING POSITION) AND PAIN WHEN FEELING COLD. IT WAS TOO PAINFUL TO HAVE SEXUAL INTERCOURSE. SYMPTOMS DID NOT IMPROVE OVER THE YEARS. THE CUSTOMER THEN USED A SILICONE GEL PRODUCT INTENDED TO HEAL SCARS ON THE SKIN OF HER HAND. HER HAND BECAME RED AND SWOLLEN. SHE IMMEDIATELY WENT TO THE DOCTOR WHO IDENTIFIED THIS AS A SILICONE ALLERGY. UNTIL THEN SHE DID NOT KNOW THAT SILICONE ALLERGY EXISTED OR THAT SHE HERSELF HAD A RARE SEVERE SILICONE ALLERGY. THE CUSTOMER REPORTED 1/3 OF THE TISSUE OF HER VAGINA THAT HAD BEEN IN CONTACT WITH THE MENSTRUAL CUP BEING AFFECTED. THE CUSTOMER SUBSEQUENTLY UNDERWENT SURGERY 7 TIMES IN 2 YEARS IN ORDER TO REMOVE A SMALL BIT OF VAGINAL TISSUE EACH TIME, ALLOWING IT TO GROW AGAIN. IN ORDER TO LIMIT PAIN, THE DOCTORS COULD NOT REMOVE ALL AFFECTED TISSUE AT ONE TIME. THE CUSTOMER REPORTED TISSUE REGROWTH BEING PAINFUL & AFFECTING HER WALKING AND HER HEALING BEING ONGOING. THE CUSTOMER CONTACTED MOONCUP LTD APPROXIMATELY 7 YEARS AFTER ALL OF THE ABOVE HAD TAKEN PLACE TO REPORT HER EXPERIENCE. AT THIS TIME, THE CUSTOMER COULD NO LONGER PROVIDE PROOF OF PURCHASE OR INDICATE SPECIFICALLY WHERE THE MENSTRUAL CUP WAS ORIGINALLY PURCHASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 883256 | MOONCUP® / MCUK® | MENSTRUAL CUP, PRODUCT CODE: HHE | HHE | MOONCUP LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |