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It was reported that on (b)(6) 2020 a biozorb was implanted in the patient, and the patient reported that suffers from persistent, sharp, stabbing pain in her breast.It was reported that the biozorb has not dissolved and instead created a large, hard lump, also that the area of the biozorb is sensitive to the touch.The patient reported that has endured infections caused by the biozorb and she also now has spider veins on her left breast.No additional information available.
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The patient is a 59-year-old african american female, 311 lbs, bmi 51.8, with a past medical history of morbid obesity, coronary artery disease (cad) with hypertension (htn), hyperlipidemia (hld), and asthma and a history of left breast infected cyst excision in (b)(6) 2016, had an "abnormal" screening mammogram of the left breast in (b)(6) 2020.She had a diagnosis of invasive ductal carcinoma on core biopsy on (b)(6) 2020 and underwent a lumpectomy with sentinel lymph node dissection (slnd) and biozorb implant placed.Her post-op course was uneventful except for minor serous fluid leakage from a small dehiscence at the lateral margin of her axillary incision that resolved within a month.Available records report that the patient received 4 cycles of taxotere and cyclophosphamide (tc) chemotherapy.There is no documentation of further concerns or complications during her follow-up course over 2.8 years.Her records reflect chronic respiratory failure and covid or cardiac related complaints.Lot number provide was unable to be traced.
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An investigation was completed: it was reported that on (b)(6) 2020, a biozorb was implanted in the patient, and the patient reported that suffers from persistent, sharp, stabbing pain in her breast.It was reported that the biozorb has not dissolved and instead created a large, hard lump, also that the area of the biozorb is sensitive to touch.The patient reported that she has endured infections caused by the biozorb and she also now has spider veins on her left breast.No additional information is available.No initial evaluation could be performed because there was no returned sample for this complaint.The sample was not returned for this complaint and there was limited patient-related information provided for this event; therefore, a thorough investigation was not able to be performed.Investigation into several of the harms reported in this complaint was performed from a clinical literature review, as well as an investigation into the design and risk of the biozorb product.The harms identified during this complaint are: major pain (pain/discomfort/device palpability/sleep disfunction/failure to resorb), moderate infection.A review of clinical literature performed on lumpectomies, and their associated complications was performed.A summary of this review concluded that, while lumpectomy is a well-established option for breast cancer treatment, it inherently carries risks of complications, most notably infections, seroma formation, chronic pain, and wound healing issues.The literature demonstrates variation in complication rates based on surgical technique, additional therapies (such as intraoperative radiation therapy (iort) or radiation), and individual patient factors, with infection rates ranging from 2% to 10% and seroma rates from 11% to 65%.Chronic pain, particularly neuropathic pain, affects nearly one-third of patients.(kwee et al.(2024)), migration can be influenced by several patient related factors which can influence the likelihood of migration after lumpectomy, such as breast density, biopsy location, and biopsy approach.Per a study by ashali jain et al.(2017), marker migration is a relatively common occurrence following stereotactic biopsies, happening in 13% of cases.Swelling is one of the expected events that could occur after surgery and/or radiation therapy regardless of the use of a biozorb device.Due to this, confirmation of the swelling during this event as a normal course of surgery vs being caused by the biozorb is not able to be done.Device explantation is based on the patient¿s physician¿s evaluation of their physical and health state and recommendation; therefore, an investigation into this intervention is not able to be performed for this complaint.Though complications are relatively common, most are manageable with appropriate postoperative care, making lumpectomy a viable option for many breast cancer patients when carefully monitored and followed up.An investigation was performed by subject matter experts (sme¿s) into several of the harms identified as being experienced by the patient related to design, risk management, and clinical factors.The results of these investigations and potential causes can be seen below; however, it is important to note that these results do not include medical input from a qualified medical professional: pain: there is a lack of migration requirements and testing to evaluate if the device can cause tissue damage due to migration.Verification of mechanical strength and simulated use is not adequate due to several opportunities related to sampling size and test methods.The crystalline proportion in the device is unknown.Crystallinity may be causing irritation and foreign body reaction considering the long period of absorption of the device.There is a lack of usability testing evaluating the user needs, so there is no assurance that the surgical methods being used for the users are adequate.There is a lack of adequate user needs to capture appropriate design inputs, and therefore there are opportunities in design outputs and v&v activities.Migration: there is a lack of migration requirements and testing to evaluate if the device can cause tissue damage due to migration.The crystalline proportion in the device is unknown.High crystallinity may be causing migration/erosion considering the long period of absorption of the device.Verification of mechanical strength and simulated use is not adequate due to several opportunities related to sampling size and test methods.There is a lack of usability testing evaluating the user needs, so there is no assurance that the surgical methods being used for the users are adequate.There is a lack of adequate user needs to capture appropriate design inputs.Based on the clinical literature review, the harms reported to be experienced by the patient in the complaint are common symptoms from surgery and lumpectomies; therefore, a confirmation of the biozorb causing the harms was not able to be done.However, based on the review of the top harms in regard to the biozorb design and risk documentation, the adverse events reported can be tracked back to a potential shared cause: lack of adequate user needs for the product.User needs define the framework for product development and lay the ground for the definition of design inputs, design outputs and later verification and validation activities.Other potential causes are related to inadequate test methods and/or the lack of evidence to support some specific product requirements.Conclusion: when comparing the safety outcomes of the biozorb marker with general lumpectomy complications, it becomes evident that some of the complications associated with biozorb may stem from the lumpectomy procedure itself.Both procedures share overlapping risks, although the biozorb device introduces additional considerations.However, it has been confirmed that the lack of defined user needs and inadequate test methods and testing evidence are potential root causes for the harms reported in this complaint.This cause will be further investigated and addressed in a capa.The risks associated with this complaint event are further described and evaluated against the product and its hazard analysis in the health risk assessment biozorb complaint analysis.Updates to the biozorb hazard analysis risk file will be monitored.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: a dhr review could not be performed because no lot information was provided.
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