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After additional medical review it was determined that a 65 years old patient, weight 112lbs, patient underwent on (b)(6) 2018, breast surgery with biozorb placement (f0221 sutured in place with 3.0 vicryl) and a left breast partial mastectomy that confirmed the diagnosis for ductal carcinoma with lobular features and the pathology report showed: stage 1a grade 1 pt1bpn0cm0 er/pr positive and her-2 negative and low oncotype score of 4.Posterior margin was not clear, so patient underwent a re-excision on (b)(6) 2018, with clear margins.Patient went asymptomatic and underwent radiation therapy from on (b)(6) 2018, up until on (b)(6) 2018 with minimal side effects.Patient declined anti estrogen therapy but ultimately started fosamax for osteoporosis.At 3 years post implantation a mammography was performed and the report stated ¨the biozorb markers had rearranged in a linear configuration the most anterior are in the palpable area of concern.Fat necrosis calcification was associated with the more posterior markers.There are suspicious masses, suspicious calcifications associated with more posterior markers.There are no suspicious masses or calcifications or new areas of architectural distortion.Patient sought a second surgical opinion for persistent pain at the implant and was counseled to use warm compresses.Physician reported that it is likely that the period of acute pain and swelling was a liquefaction of the biodegradable frame, and the acute swelling reduced when the degraded portion of the implant was absorbed.It is unclear whether the remnants will go on to extrude through the scar.The physician discussed with the patient that if pain increases and the scar suddenly disrupts as the fragments are extruded, it is likely to be a self-limited process and to heal promptly.Physician recommended the patient to try warm compresses, which will either promote absorption or extrusion.If the pain and mass persist, it may be possible to remove these through the same scar and in the process of closing, elevate the retracted scar.No device explantation was reported.Patient medical history: patient had asymptomatic positive screening mammogram and ultrasound identified on left breast a spiculated 4x6x5 mm mass.Patient underwent needle biopsy on (b)(6) that was positive for invasive ductal carcinoma with lobular features.Mri identified another non-mass enhancement that correlated with the ultrasound that was not pursued.Additionally, a 6 mm non-mass enhancement was identified on her right breast.Past history of right breast needle biopsy (negative) in 1999.No use of hrt; 5 years ocp; osteoporosis identified pretreatment with tamoxifen at bone density testing.Family medical history reported: maternal aunt dcis at age 65.Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.
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An investigation was completed: it was reported that on (b)(6) 2018 a patient underwent a left partial mastectomy with preoperative wire localization and bracketing, additionally a intraoperative ultrasound was used, flap advancement closure and a left sentinel biopsy with biozorb placement.Patient had a prior diagnosis of invasive mammary/ductal carcinoma on her left breast.On (b)(6) 2018, the patient underwent a left partial mastectomy and flap advancement closure with a biozorb placement.The patient reported that she has experienced pain and swelling at the implantation site and that the pain has migrated to her nipple.Patient has not had the device removed to avoid additional surgeries.Patient believes their breast cancer diagnosis and fear it has returned, every day, causing significant emotional distress.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), minor inflammation (inflammation/swelling/lymphedema/limited mobility), 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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