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After additional medical review it was determined a 52 years old patient, weight 164libs and bmi of 26.2 had on september 15th 2016 a left wire localized partial mastectomy and left sentinel node biopsy with placement of biozorb (3x2x1 sutured to the chest wall using 3-0 pds suture to help with targeting the post operative radiation therapy) and mastopexy.Post closure it appeared that there was a slight amount of tethering from the nipple following the closure and the defect left from the tumor and the decision was made to open a small part of the patient´s prior periareloar incision.Additionally a small amount of breast skin in that site was resected in order to improve the closure and appearance of breast.At this time the port-a-cath was removed from the chest wall.Pathology results revealed an area of invasive ductal carcinoma remained status post neoadjuvant chemotherapy grade 3 invasive ductal carcinoma, poorly differentiated, 5 mm at greatest length and negative final margins, dcis present and no lymphatic involvement.Immediate post course was complicated with minor skin irritation just superior to the nipple determined to be due to the dye used for sentinel node localization.Patient underwent whole breast radiation with boost from october 2016 up until november 2016 and was treated with a high dose dense adriamycin/cytoxan followed by weekly taxol.The patient was noted to develop a significant amount of scarring that is painful along her chest wall as well as contour deformity of the lover left outer breast.To correct these issues a plan was made for left breast reconstruction with tissue rearrangement and fat grafting.In september 2017 patients underwent left breast reconstruction with fat grafting from the abdomen and removal of the port-a-cath, the operative report stated that the biozorb device was stuck to the chest wall but was freed up with release of some underlying scar tissue.Biozorb was not reported removed during this procedure.3 years post radiation, a note from the physician reported patient has a beautiful cosmetic result.The ipsilateral left breast has no stigmata from radiation therapy.Patient incisions have beautifully healed reduction pattern incisions.In the lumpectomy site on deep palpation a small induration was palpated.There are no areas of concern in any of the breasts.Patient later underwent therapy to treat left upper extremity cording, scar adhesions, lymphedema and tenderness in the left breast.Primary visit noted a normal breast exam, no reports of tenderness or lumps.A note from her oncologist in january 2023 reported no breast pain/tenderness/lump.A note from her plastic surgeon reported that in an mri some scar tissue was observed around the site, muscles look symmetrical and its related to other things like radiation and potential scar tissue around nerves at the site.Though the scar reaction around the biozorb could certainly be contributing to local nerve inflammation.On january 29th, 2024, the patient underwent bilateral breast reconstructive surgery with biozorb device explant.Surgeon reported patient had chronic pain and palpable scar tissue on the left breast and thus presents for excision of the area of scar tissue around the bioabsorbable marker.Additionally, she has deformity of the left breast and breast asymmetry and will be undergoing left breast reconstruction revision with fat grafting and mastopexy revision of the breast as well as the right breast reduction mammoplasty for symmetry".The operative report noted "dissection continued until the bioabsorbable marker was reached with a palpable scar tissue.The area was excised down to the chest wall.It was marked and specimen radiograph was then confirmed with bioabsorbable markers, the site was assessed and there did not appear to be any evidence of any nerve injury throughout lumpectomy." explant pathology of the left breast found: ¿scar tissue and rare degenerative changes.Microcalcifications associated with benign ducts and stroma prominent scar tissue with foamy macrophages and multinucleated giant cells, do not provide evidence for residual invasive carcinoma a 2.7x1.4x0.6cm white, firm and stellate fibrous area which was related to the biozorb.In march, 2024, post explant/reconstruction surgery, the patient had a breast infection with abscess treated with incision and drainage, several rounds of antibiotics and an admission for iv antibiotic therapy.Medical history of bilateral cyst breast with drainage, bilateral breast reduction mammoplasty in feb 2016, meningioma, depression and multiple allergies to medications.Screening mammograms demonstrated heterogenous dense breast with multiple cysts.After 2016 patient experienced a rapidly progressive painful mass on her left breast.A mammogram prompted a left breast biopsy in april 2016 which revealed a grade 3 poorly differentiated ductal carcinoma, weakly er/pr+, her2/neu - clinical t2n0m0.Patient had a port-a-cath placement in the right chest wall and neoadjuvant chemotherapy.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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It was reported that a patient underwent a lumpectomy on (b)(6) 2016, during which a biozorb was implanted.Patient had a prior diagnosis of left breast invasive ductal carcinoma.Patient reported that she developed a significant amount of scaring on her chest wall at the implantation site.Patient reported that she suffered from deformity, scarring, and hard painful lumps that limited her mobility.Patient received a surgery in which the biozorb was reported to have been separated from her chest wall.Patient reported that she is going to physical therapy to address the pain, mobility and muscle loss related to the surgery.Patient reports that she is still in constant pain.Patient fears the possibility of another tumor, 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: limited mobility, scar tissue, pain, deformity.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%.Limited mobility (inflammation / swelling / lymphedema) biozorb (0.7%): tissue damage, including wound dehiscence and erosion, was reported in 0.7% of patients with the biozorb marker.In a more severe case, the biozorb device eroded into the nipple-areola complex, necessitating complete removal of the nipple-areola complex due to chronic inflammation.However, given that wound healing issues, tissue necrosis, and other damage are known complications of lumpectomy itself, some of these outcomes could be directly related to the surgical trauma and healing process rather than the device.Lumpectomy (13.1% of patients, delayed healing in 6.5%, and skin-flap necrosis in 1.1%, indicating that tissue damage): wound healing issues and tissue necrosis are common after lumpectomy, particularly in cases where large amounts of tissue are removed or additional procedures such as radiation are performed.Knowles et al.Reported wound infection in 13.1% of patients, delayed healing in 6.5%, and skin-flap necrosis in 1.1%, indicating that tissue damage can be a lumpectomy-related issue.Regarding lumpectomy¿s, berger et al.(berger l, grimm a, sutterlin m, et al.Major complications after intraoperative radiotherapy with low-energy x-rays in early breast cancer.Strahlenther onkol.Apr 2024; 200(4):276-286.Doi: 10.1007/s00066-023-02128-z) retrospectively analyzed the occurrence of severe local complications in 10 out of 408 women who underwent intraoperative radiotherapy (iort) with low-energy x-rays during breast-conserving surgery (bcs) for early breast cancer between 2002 and 2017.The complications, which required surgical intervention, included redness (80%), seroma (60%), wound infection (60%), suture dehiscence (60%), and induration (40%).Hematoma and necrosis were less common (10% each).These symptoms emerged from immediately post-operation up to 15 years later, with a median onset at 3.1 months.While most complications were managed with smaller surgical interventions, such as excision of necrotic areas or secondary sutures, more severe cases required complex flap surgery or mastectomy.The study concluded that although iort is generally safe, it carries a risk of severe complications.Preoperative counseling and vigilant follow-up are recommended to manage these risks effectively.Pain biozorb (0.9% to 1.9%): pain or discomfort was reported in 0.9% to 1.9% of patients with the biozorb marker.In one instance, discomfort occurred due to the device being sutured to the serratus muscle but did not result in removal.In another study, discomfort in 1.1% of patients led to device removal.However, given that pain is a well-known complication following lumpectomy, particularly in cases with nerve damage or radiation therapy, some of this discomfort could be attributed to the initial surgical intervention rather than the presence of the marker.Lumpectomy (25% to 60%): chronic pain is a frequent long-term complication of lumpectomy, affecting 25% to 60% of breast cancer surgery survivors.Kwee et al.Reported a pooled prevalence of 31% for neuropathic pain following bcs.The presence of post-surgical pain, particularly neuropathic pain caused by nerve damage, could be exacerbated by or misattributed to the biozorb marker in some cases.Scar tissue (tissue damage / delayed wound healing / necrosis / erosion) biozorb (0.7%): tissue damage, including wound dehiscence and erosion, was reported in 0.7% of patients with the biozorb marker.In a more severe case, the biozorb device eroded into the nipple-areola complex, necessitating complete removal of the nipple-areola complex due to chronic inflammation.However, given that wound healing issues, tissue necrosis, and other damage are known complications of lumpectomy itself, some of these outcomes could be directly related to the surgical trauma and healing process rather than the device.Lumpectomy (13.1% of patients, delayed healing in 6.5%, and skin-flap necrosis in 1.1%, indicating that tissue damage): wound healing issues and tissue necrosis are common after lumpectomy, particularly in cases where large amounts of tissue are removed or additional procedures such as radiation are performed.Knowles et al.Reported wound infection in 13.1% of patients, delayed healing in 6.5%, and skin-flap necrosis in 1.1%, indicating that tissue damage can be a lumpectomy-related issue.Deformity (physical asymmetry / disfigurement) rahimi 2022 (rahimi a, simmons a, kim dn, et al.Preliminary results of multi-institutional phase 1 dose escalation trial using single-fraction stereotactic partial breast irradiation for early-stage breast cancer.Int j radiat oncol biol phys.Mar 1, 2022; 112(3):663-670.Doi: 10.1016/j.Ijrobp.2021.10.010) concluded that cosmetic outcomes were preserved, with no significant cosmetic detriment across any dose cohort, suggesting that single-fraction s-pbi does not negatively affect patients' physical appearance post-treatment.Both patient- and physician-reported cosmetic scores were consistently favorable over 12 and 24 months of follow-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 regards 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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