{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 10
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "NO INFORMATION",
      "report_to_fda": "I",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "N",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "MW5097829",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20201112",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20160205",
      "reprocessed_and_reused_flag": "I",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "PATIENT",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        ""
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20201113",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1298862",
          "implant_date_year": "2006",
          "date_removed_year": "2020",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20201112",
          "brand_name": "MCGHAN 68 SALINE BREAST IMPLANT",
          "generic_name": "PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE",
          "manufacturer_d_name": "MCGHAN / ALLERGAN",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "I",
          "model_number": "68MP",
          "catalog_number": "",
          "lot_number": "1191270",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "FWM",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Prosthesis, Breast, Inflatable, Internal, Saline",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.3530",
            "device_class": "3"
          }
        },
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1298863",
          "implant_date_year": "2006",
          "date_removed_year": "2020",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20201112",
          "brand_name": "MCGHAN 68 SALINE BREAST IMPLANT",
          "generic_name": "PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE",
          "manufacturer_d_name": "MCGHAN / ALLERGAN",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "I",
          "model_number": "68MP",
          "catalog_number": "",
          "lot_number": "1195034",
          "other_id_number": "",
          "device_availability": "No answer provided",
          "device_report_product_code": "FWM",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Prosthesis, Breast, Inflatable, Internal, Saline",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.3530",
            "device_class": "3"
          }
        }
      ],
      "product_problems": [
        "Adverse Event Without Identified Device or Use Problem"
      ],
      "reporter_state_code": "MO",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250804",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20201112",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Hospitalization",
            " S"
          ],
          "patient_age": "44 YR",
          "patient_sex": "",
          "patient_weight": "59",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Bacterial Infection",
            "Chest Pain",
            "Fatigue",
            "Hypersensitivity/Allergic reaction",
            "Pain",
            "Thyroid Problems",
            "Immunodeficiency",
            "Tingling",
            "Headache, Lumbar Puncture",
            "Cytomegalovirus (CMV) Infection",
            "Anxiety",
            "Numbness",
            "Fungal Infection",
            "Unspecified Gastrointestinal Problem",
            "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available",
            "Bacterial Infection",
            "Chest Pain",
            "Fatigue",
            "Hypersensitivity/Allergic reaction",
            "Pain",
            "Thyroid Problems",
            "Immunodeficiency",
            "Tingling",
            "Headache, Lumbar Puncture",
            "Cytomegalovirus (CMV) Infection",
            "Anxiety",
            "Numbness",
            "Fungal Infection",
            "Unspecified Gastrointestinal Problem",
            "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20201109",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10836618",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "216328767",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "I HAD MCGHAN 68 SALINE BREAST IMPLANTS PUT IN (B)(6) 2006. SEVERAL YEARS AFTER THAT I BEGAN HAVING PROBLEMS WITH DIGESTION AND MY THYROID. IN THE YEARS FOLLOWING I WAS EVENTUALLY DIAGNOSED WITH CHRONIC FATIGUE, FIBROMYALGIA, HASHIMOTO'S, LYME DISEASE, (B)(6), CYTOMEGALOVIRUS, H PYLORI, DEBILITATING HEADACHES, NECK AND SHOULDER PAIN, MOLD TOXICITY, NUMBING AND TINGLING IN MY ARMS AND FINGERS, CHEST PAIN, ANXIETY, STOMACH ACID DEFICIENCY, MULTIPLE DIGESTIVE DISORDERS, SEVERE FOOD ALLERGIES TO MOST FOODS, AND CHRONIC IMMUNE DEFICIENCY. I SPENT (B)(6) OF DOLLARS IN DOCTORS APPOINTMENTS, HOSPITAL VISITS, IV THERAPY, OZONE THERAPY, BLOOD IRRADIATION THERAPY, CHELATION, SUPPLEMENTS AND SO MUCH MORE TRYING TO FIND OUT WHAT HAPPENED TO A HEALTHY 40 SOMETHING-YEAR-OLD WOMAN. IN THE FALL OF 2019, I WAS OFFICIALLY DIAGNOSED WITH BREAST IMPLANT ILLNESS AND HAD MY IMPLANTS REMOVED VIA EN BLOC (B)(6) 2020. IT'S BEEN SIX MONTHS SINCE MY SURGERY AND NEARLY ALL OF THE SYMPTOMS HAVE DISAPPEARED. I HAVE MY LIFE BACK. PLEASE TAKE MY TESTIMONY SERIOUSLY. ALL BREAST IMPLANTS HARM. ALL, NONE ARE SAFE. I WISH I WOULD HAVE KNOWN. I WERE TOLD THEY WERE SAFE. I'VE LOST AT LEAST THE LAST 5 YEARS OF MY LIFE WHEN SYMPTOMS WERE THE WORST BUT SO GLAD TO HAVE THEM OUT. FDA SAFETY REPORT ID# (B)(4)."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}