Early Use and Outcomes of Polydioxanone Mesh in Implant-based Breast Reconstruction

Abstract

Background:

As the diagnosis of breast cancer has increased during the past 2 decades, so too has the number of resection procedures, including mastectomies. Of the available reconstructive options postmastectomy, implant-based breast reconstruction (IBBR) predominates. Biologic scaffolds, such as human acellular dermal matrices, are routinely used to support tissue expanders and implants. However, human acellular dermal matrices have several limitations, including high infection rates, high cost, and supply concerns. Synthetic scaffolds address some of these concerns, though they differ significantly in time to resorption. In this study, we reported data from IBBR using polydioxanone (PDO) mesh.

Methods:

This prospective, multisite, observational registry study evaluated the use of PDO mesh (DuraSorb) implanted during IBBR, including 2-stage and direct-to-implant procedures. Based on the timing of PDO mesh placement, success was defined as the placement of a permanent implant or completion of reconstruction in the absence of major adverse events requiring expander or permanent implant removal. Adverse events were also recorded.

Results:

Procedural success with PDO mesh was 97.2% (n = 71), 96.9% (n = 32), and 75% (n = 4) when implanted at the time of the tissue expander, permanent implant placement, and direct-to-implant procedures, respectively. The incidence of infection, skin flap necrosis, and seroma requiring drainage was 6.5%, 12.2%, and 10.3% of breasts, respectively. No medical complications (deep vein thrombosis, pulmonary embolism, cardiac events, acute renal failure, difficulty weaning from the ventilator) were reported.

Conclusions:

IBBR using PDO mesh demonstrated favorable safety and performance outcomes in this observational study.

Takeaways

Question: What performance and safety outcomes have been observed in implant-based breast reconstruction (IBBR) procedures using polydioxanone (PDO) mesh?

Findings: This prospective, multisite, observational registry study evaluated the use of PDO mesh (DuraSorb) implanted during IBBR. Procedural success with PDO mesh was 97.2% (n = 71), 96.9% (n = 32), and 75% (n = 4) when implanted at the time of the tissue expander, permanent implant placement, and direct-to-implant procedures, respectively. The incidence of infection, skin flap necrosis, and seroma was 6.5%, 12.2%, and 10.3% of breasts, respectively.

Meaning: IBBR using PDO mesh demonstrated favorable safety and performance outcomes.

INTRODUCTION

Breast cancer is the most commonly diagnosed malignancy among women in the United States. An estimated 297,790 new cases were expected to be diagnosed in women in 2023, with an additional 55,720 cases of premalignant in situ lesions.^1–4 These values represent an increase in the total number of diagnosed breast malignancies by 28% in the decade since 2013, resulting in an annual case growth rate of 2.8%.⁵ Consequently, procedures to surgically treat breast cancer have also increased, including the number of breast conserving procedures, mastectomies for breast cancer (with or without contralateral prophylactic mastectomies), and bilateral prophylactic mastectomies.⁶

By extension, the demand for breast reconstruction has never been greater, with an increase of nearly 40% in the number of reconstructive procedures during the last 2 decades.⁷ At present, the psychosocial benefits of postmastectomy breast reconstruction are so widely recognized that state and federal policies now require patient-provider discussions about reconstruction and mandate insurance coverage.^8–11 Postmastectomy breast reconstruction may be performed using autologous or alloplastic approaches, each with its own risks and benefits.^12–14 Implant-based breast reconstruction (IBBR) is currently the dominant reconstructive approach postmastectomy and comprises more than 80% of breast reconstruction procedures.^7,15

IBBR may be performed via either a direct-to-implant (DTI) or 2-stage approach, the latter of which involves the use of a tissue expander (TE) placed either anterior (the prepectoral approach) or posterior (the subpectoral approach) to the pectoralis muscle at the time of mastectomy.^16–19 The movement toward prepectoral techniques has been facilitated by support scaffolds, including acellular dermal matrices (ADMs) and resorbable synthetic meshes.^20,21 As there is no overlying muscular padding in the prepectoral approach, the implanted scaffold serves as a primary source of support and coverage of the implant beneath the skin and helps to address concerns regarding ischemia of the surrounding tissue.^19–27 Although tabbed and textured TEs may similarly help to reinforce capsular support and minimize complications in prepectoral reconstruction without implanted mesh,²² lower rates of capsular contracture postradiation therapy have been reported with the use of ADM.^24,25 However, the rate of other complications, such as mastectomy flap necrosis, may be higher with ADM use.²⁰

Biologic scaffolds, such as ADMs, are widely used in 2-stage IBBR to support the TE and facilitate adequate pericapsular tissue maturation. ADMs are derived either from animal or human cadaveric sources and are the most common scaffolds used in 2-stage subpectoral and prepectoral approaches; in fact, ADMs are used in more than 80% of IBBRs in the United States.²⁶ Since their introduction to breast reconstruction in the early 2000s, ADMs have been considered the standard of care despite labeling under a purely general indication.²⁸ Several key limitations have been associated with human ADMs, including high rates of infection,^1,3 associated ADM explantation (with aseptically processed products),^29,30 and incidence of clinically significant seroma (with sterile products).^31–34 Furthermore, surgeons face a trade-off between ADM thickness and safety; although thicker ADMs have demonstrated better implant coverage and support, they are also less readily incorporated into overlying tissue, presenting a heightened risk for inflammatory foreign body reactions.³⁵ Because ADMs are derived from mammals and require extensive processing, they also carry high economic and logistical burden, with costs averaging between $3500 to $4850 per breast.^2,36,37 Per-breast cost may vary widely based on factors such as the technique used and provider-specific preferences regarding the amount of scaffolding. Using the lower value in this range and taking into account the proportion of unilateral and bilateral breast reconstructions, as well as the number of total reconstructions with ADM, at least $215–$330 million was likely spent on ADMs in 2018 alone, dwarfing the cost of the permanent implants themselves.^38,39

More recently, support scaffolds made from materials other than dermis have emerged as sterile, scalable alternatives to address the safety and supply limitations inherent to their dermal predecessors. These comparatively newer products are composed of resorbable polymers, either synthetically produced or biologically derived, all of which are marketed under the same general indication as dermal scaffolds. Setting aside subjective differences in handling and chemical properties, 1 primary differentiating factor among non-ADM scaffolds currently on the market is the time to scaffold resorption. A recent review of the Mastectomy Reconstruction Outcomes Consortium registry study literature demonstrated a mean time to exchange surgery of 5.5 months⁴⁰ (Fig. 1). Although many factors influence the successful maturation of a periprosthetic pocket, a resorbable scaffold would ideally persist long enough to support the formation of the tissue pocket while ultimately incorporating into the local tissue in a timely manner to prevent foreign body reactions and associated complications.

Fig. 1.

A bar chart demonstrating the degradation profiles of several synthetic absorbable meshes. The red bar indicates the timing of permanent breast implant placement. MROC, Mastectomy Reconstruction Outcomes Consortium.

More recently, polydioxanone (PDO) mesh (DuraSorb, Surgical Innovation Associates [SIA], Chicago, IL) has demonstrated retained strength 3–4 months postimplantation and is reabsorbed by the body in less than 1 year. PDO suture has been widely used in surgery for nearly 40 years, and although biocompatibility has been well established, its use as a support scaffold in cosmetic breast surgery and breast reconstruction is less well understood.^41–49 Recently, a prospective study of 27 breasts examined adverse events following PDO mesh use in revision cosmetic breast surgery. There were no reported infections, wound-healing complications, or instances of capsular contracture during the follow-up period, and the incidence of seroma formation was limited to 1 case (4%).⁵⁰ Additionally, a recent prospective study explored the use of PDO mesh in 7 patients undergoing bilateral, 2-stage, prepectoral IBBR. Only 1 late infection (7.1% of procedures) was reported in the study and was not attributed to PDO mesh.²¹ A separate retrospective study reported on outcomes from 105 revision-augmentation procedures using PDO mesh as a support matrix. Two infections (2%), 2 seromas (2%), 1 wound-healing complication (1%), and no mesh-related complications were reported.⁴⁸ The purpose of the present observational study was to report on the use of PDO mesh in 2-stage and DTI alloplastic breast reconstruction following mastectomy.

METHODS

The prospective, multisite, open-label, observational registry study collects outcomes and adverse event data following the use of PDO mesh in a variety of surgical procedures where soft tissue reinforcement is indicated. Participating institutions completed a qualification process to confirm case volume and research expertise. Institutional review board approval and site initiation occurred before recruiting and enrolling subjects. Data were collected via a centralized electronic data capture system, and data entry methods were the same at all sites. Patients were enrolled if they met the following criteria: female, older than 22 years, not pregnant, and in need of soft tissue support. All IBBR cases in the registry that met the aforementioned inclusion criteria were analyzed. IBBR data were analyzed from the general subject pool of study data that included cases from 3 plastic surgeons at 3 different institutions. Given that the present series was derived from an observational registry, no control group was established. Decisions regarding when to use the commercially available PDO mesh and at what stage to implement the product were made independently at the discretion of the surgeons.

Adverse events were assessed, as reported by surgical site complications and medical complications, in aggregate and by procedure. Included were the most common wound complications associated with implantable support scaffolds, such as capsular contracture, dehiscence, seroma, and hematoma. Medical complications included deep vein thrombosis, pulmonary embolism, acute renal failure, cardiac events, and ventilator dependence. For the purposes of reporting, reconstruction success with PDO mesh was defined contingent upon the time of PDO mesh placement. If the mesh was placed at the time of mastectomy to support the TE (Fig. 2), success was defined as successful TE exchange with a permanent implant. If the mesh was placed at the time of the permanent implant in either 2-stage (Fig. 3) or DTI cases, success was defined as the absence of implant removal through 6 months of follow-up. (See figure, Supplemental Digital Content 1, which displays a photograph of PDO mesh placed at the time of prepectoral permanent implant placement, https://links.lww.com/PRSGO/E581.) In those patients undergoing mesh placement at the time of permanent implant exchange, capsulotomies were performed before mesh insetting. Electronic medical records were used to collect patient demographic and outcome-related information. Descriptive statistics and a time series analysis were conducted using Stata version 18.5 (StataCorp, College Station, TX) with a significance level of 0.05 to assess postoperative outcomes. In light of the variable time to follow-up among breasts included in the study, a Kaplan–Meier analysis was conducted to estimate the probability of complication-free survival over time. Time to complication was defined as the time between the index application of mesh and the occurrence of a complication.

Fig. 2.

Photograph of PDO mesh placed at the time of prepectoral TE placement.

Fig. 3.

Photograph of PDO mesh placed at the time of partial subpectoral TE placement.

RESULTS

Sixty-two female subjects from 3 sites who underwent IBBR between February 27, 2020, and August 15, 2022, met the inclusion criteria for this study. The population was 53.2 ± 11.4 years old, and the following comorbidities were reported: current smoking (n = 4, 6.5%); former smoking (n = 11, 17.7%); obesity, defined as body mass index of more than 30 kg/m² (n = 17, 27.4%); diabetes (n = 6, 9.7%), hypertension (n = 17, 27.4%); history of radiation at the surgical site (n = 4, 6.5%); and 2 or more comorbidities (n = 41, 66%) (Table 1).

Table 1.

Characteristics of Patient Population (N = 62)

Category	n	%
Reported sex
Female	62	100
Age (mean, y)	53.23
Race
White	9	14.52
Black	1	1.61
Asian	2	3.23
Other	3	4.84
Unknown	47	75.81
Body mass index, kg/m2
<18.5	1	1.61
18.5–25	18	29.03
25–30	26	41.94
>30	17	27.42
Smoking status
Never	45	72.58
Former	11	17.74
Current	4	6.45
N/A	2	3.23
Diabetes
No	56	90.32
Yes	6	9.68
Hypertension
No	45	72.58
Yes	17	27.42
Hx of cancer at anatomical location
No	1	1.61
Yes	61	98.39
Hx of radiation at anatomical location
No	58	93.55
Yes	4	6.45

Hx, history, N/A, not applicable.

Among the enrolled population, 60 women underwent 2-stage IBBR (n = 103 breasts) and 2 underwent DTI (n = 4 breasts). For the 2-stage patients, 43 (69.4%, n = 71 breasts) had PDO mesh placed at the first stage of breast reconstruction, whereas the remaining 17 (27.4%, n = 32 breasts) 2-stage subjects had mesh placed at the time of permanent implant placement (along with the 2 DTI subjects) (Table 2). Forty-five subjects underwent bilateral IBBR (72.6%), and 17 underwent unilateral reconstruction. Ultimately, 107 distinct breast reconstructions using PDO mesh were available for analysis. The mean duration of follow-up from the time of mesh implantation was 26.9 ± 8.3 months (Table 3).

Table 2.

Reconstruction Procedure Characteristics (N = 62)

Characteristic	n	%
No. reconstructed breasts	107
Reconstruction procedure laterality
Unilateral IBBR	17	27.42
Bilateral IBBR	45	72.58
Time of PDO mesh implantation
With TE	43	69.35
With permanent implant (2-stage)	17	27.42
With permanent implant (DTI)	2	3.23
PDO mesh use during procedure
Single layer/conventional	47	75.81
Double layer/folded over	15	24.19

Table 3.

IBBR Patient Time in Study (N = 62)

19-002 IBBR Procedure	Mean Time in Study in Months ± SD
Immediate reconstruction (n = 43)	29.24 ± 5.84
Implant exchange reconstruction (n = 17)	22.24 ± 7.95
DTI reconstruction (n = 2)	15.0 ± 1.0
Total	26.85 ± 6.71
	Median time in study in months (IQR)
Immediate reconstruction (n = 43)	24 (9)
Implant exchange reconstruction (n = 17)	12 (9)
DTI reconstruction (n = 2)	12 (0.5)
Total	24 (9.24)

IQR, interquartile range.

In regard to adverse events, of the 107 breasts enrolled, 7 infections required intervention (6.5%), of which 4 occurred in a breast with mesh placed at the time of the TE and 3 occurred in a breast with mesh placed at the same time as the permanent implant. One superficial dehiscence (0.9%) was reported in a breast that underwent mesh placement at the time of TE placement. One deep dehiscence (0.9%) was reported in a breast with mesh placed at the same time as the permanent implant. Thirteen cases of any skin flap necrosis (12.2%) were reported, of which 12 occurred in a breast with mesh placed at the time of the TE and 1 occurred in a breast with mesh placed at the same time as the permanent implant. Eleven seromas requiring drainage (10.3%) were reported, of which 8 occurred in a breast with mesh placed at the time of the TE and 3 occurred in a breast with mesh placed at the same time as the permanent implant. No medical complications on the order of deep vein thrombosis, pulmonary embolism, cardiac events, renal events, or ventilator dependence were reported (Table 4).

Table 4.

Complications by Treated Breast (N = 107)

	Follow-up Time Point
	Day of Procedure	2 Wk PostSurgery	1 Mo PostSurgery	3 Mo PostSurgery	1 Y Follow-up	2 Y Follow-up	3 Y Follow-up	Total	Incidence Rate, %
Wound complication
Infection requiring intervention	0	0	3	3	1	0	0	7	6.54
Superficial skin dehiscence	0	1	0	0	0	0	0	1	0.93
Deep dehiscence	0	0	1	0	0	0	0	1	0.93
Skin flap necrosis	0	10	1	2	0	0	0	13	12.15
Seroma requiring drainage	0	7	1	4	0	0	0	11	10.28
Hematoma requiring draining	0	0	0	0	0	0	0	0	0.00
Baker grade III + capsular contracture	0	0	0	0	0	0	0	0	0.00
Mesh exposure	0	0	0	0	0	0	0	0	0.00
Mesh palpability	0	0	0	0	0	0	0	0	0.00
Other wound complication	0	0	0	0	0	0	0	0	0.00
Total wound complications	0	18	6	9	1	0	0	33	30.84
Medical complication
Deep vein thrombosis	0	0	0	0	0	0	0	0	0.0
Pulmonary embolism	0	0	0	0	0	0	0	0	0.0
Cardiac event	0	0	0	0	0	0	0	0	0.0
Renal failure	0	0	0	0	0	0	0	0	0.0
Difficulty weaning from ventilator	0	0	0	0	0	0	0	0	0.0
Total medical complications	0	0	0	0	0	0	0	0	0.0

With respect to the performance criteria, 97.2% of breasts undergoing reconstruction with PDO mesh placement at the time of TE implantation resulted in successful permanent implant exchange. Of those breasts undergoing PDO mesh implantation at the time of permanent implant exchange, 96.9% of the procedures were successful. Finally, of the 4 breasts that underwent mesh implantation at the time of bilateral DTI reconstruction, 75% of the procedures were successful at the time of last follow-up (Table 5). A preoperative and postoperative photograph of a patient undergoing bilateral IBBR with PDO mesh is represented in Figure 4. The results of the Kaplan–Meier analysis are reported in Figure 5.

Table 5.

Procedure Outcomes by Treated Breast (N = 107)

19-002 IBBR Procedure	Procedure Failure Due to Removal or Major Revision	Procedure Success	Rate of Success, %
First-stage reconstruction (n = 71)	2*	69	97.2
Permanent implant exchange (n = 32)	1*	31	96.9
DTI reconstruction (n = 4)	1†	3	75.0

^*Implant removal due to infection.

^†Patient elected for implant removal due to discomfort.

Fig. 4.

Preoperative and postoperative photographs. Preoperative (A, B) and postoperative photographs (C, D) of a patient undergoing bilateral breast reconstruction with PDO mesh.

Fig. 5.

Kaplan–Meier analysis plotting probability of wound complication–free survival over time. CI, confidence interval, KM, Kaplan–Meier.

DISCUSSION

This observational study reported on adverse events and performance-related outcomes of IBBR using PDO-based surgical mesh (DuraSorb). This is important because synthetic scaffolds are increasingly used in IBBR in the context of widespread historical ADM use. Though the use of synthetic scaffolds is growing, there is little data available on complications and performance in alloplastic breast reconstruction. In our study, which included 62 patients and 107 breasts where PDO mesh was implanted, most patients (60) underwent 2-stage alloplastic breast reconstruction. The patient population’s average age of 53.2 years is largely congruent with the populations observed in other recent studies^3,51,52 and is consistent with national data on breast cancer incidence by age.⁵³

Consistent with other studies reporting on the use and performance of mesh use in IBBR, common wound complication metrics such as infection, seroma, hematoma, skin flap necrosis, and contracture were examined in the present study. Because conversations regarding differences in risk profiles by technique are outside the scope of the present study, aggregate adverse outcomes were reported. We observed a 6.5% infection rate in this study. Rates of infection associated with biologic and synthetic mesh use vary significantly in the literature, with values as wide as 0.2%–35.8% reported. Human ADM use has been associated with higher rates of infection within this range.³⁰ In the present study, we report an infection rate that is lower than that reported historically for certain ADMs.⁵⁴ Eleven seromas required drainage (10.3%) and 13 cases of any skin flap necrosis (12.2%) were observed. Reported rates of skin flap necrosis vary greatly in the literature, but studies have reported rates as high as 23.7%–34.2% with human ADM use.⁵⁵ No hematomas requiring drainage or capsular contracture were reported. Additionally, no incidents of mesh exposure or palpability were observed in the current study. These results are consistent with the prospective study by Turin and Gutowski⁵⁰ on the use of PDO mesh in cosmetic revisions. No infections, wound-healing complications, or capsular contractures were reported, and the per-breast (n = 27) incidence of seroma requiring drainage was 4%.⁵⁰ Similarly, Qiu and Seth²¹ reported 1 case (7.1% of procedures, as reported per breast) of late infection and no other reportable complications for PDO mesh in prepectoral 2-stage IBBR. The results of the present study support the prior literature on the complication profile of PDO mesh use in breast reconstruction. With regard to the Kaplan–Meier analysis performed in the present study, the initial sharper step-offs in the first 12 weeks postoperatively, followed by a shallower decline and eventual plateauing of complication-free survival, are suggestive of a higher rate of complications in the weeks immediately following surgery. This pattern suggests that the likelihood of remaining complication-free increases over time.

Performance criteria for the 2-stage IBBR patients were determined by the time of placement of the synthetic PDO mesh scaffold. In patients who had PDO mesh placed at the time of TE placement in 2-stage breast reconstruction, performance success was defined as successful TE exchange for a permanent implant. If PDO mesh was placed at the time of permanent implant placement, success was defined as permanent implant retention through the follow-up period. Several studies on biologic and synthetic mesh use in breast reconstruction similarly described success in relation to implant explantation.^3,52 Other studies, such as that conducted by Lohmander et al,⁵⁴ defined mesh performance success as preventing unplanned reoperations. We believe that our more specific performance endpoints, TE exchange and implant retention, effectively capture the pertinent objectives of implantable scaffolds in 2-stage IBBR and DTI. In addition, these endpoints are consistent with the roles of mesh in oncoplastic breast surgery as described by Whisker et al.⁵⁶ For 2-stage IBBR with PDO mesh placement during first-stage reconstruction, 97.2% of the procedures, as reported per breast, were successful in making it to permanent implant exchange. One patient who more recently underwent 2-stage IBBR with PDO mesh placement at the time of TE placement had not yet undergone TE exchange at the time the analysis was conducted and was thus excluded from the success calculation; however, no adverse events that would preclude them from TE exchange were reported at the time of last follow-up. For 2-stage IBBR with PDO mesh placement during permanent implant exchange, 96.9% of the procedures, as reported per breast, were successful. For DTI IBBR, 75% of the procedures, as reported per breast, were successful, with success similarly defined as implant retention. It is important to note that only 2 patients (4 breasts) undergoing DTI were included in the study. Although data on the use of PDO mesh in IBBR are limited given its novelty, Qiu and Seth²¹ described 1 case (7.1%) of failure to make it to permanent implant exchange caused by a late infection in their prospective study on PDO mesh use in prepectoral 2-stage IBBR.

In contrasting the earlier outcomes with the results of other synthetic scaffolds reported in the literature, TiLOOP Bra (pfm medical, Cologne, Germany)—a nonabsorbable titanium-coated polypropylene mesh—had a reported per-breast explanation rate of 7.8%.³⁹ Dieterich et al⁵⁷ reported a per-breast implant loss rate of 8.7% with the TiLOOP Bra in IBBR. Similarly, other available absorbable meshes that persist far beyond the benchmark have been demonstrated to increase risk to both local tissue and permanent implants after the exchange.³⁹ For example, a recent study of 2-stage breast reconstruction using TIGR Matrix (Novus Scientific, Uppsala, Sweden)—a synthetic multifilament copolymer mesh that takes up to 3 years to resorb—demonstrated increased rates of infection and mesh extrusion (15.8%), seroma (10.5%), and flap necrosis (5.3%) as reported per breast.⁴¹ GalaFLEX (BD, Franklin Lakes, NJ)—a poly-4-hydroxybutyric acid synthetic mesh that persists for 2 years—demonstrated 11.2% and 11% rates of infection and explantation, respectively, as reported per breast.⁴² By comparison, common Vicryl (Ethicon, J&J) mesh has demonstrated good outcomes with a per-breast explantation rate of 6.3%, although it loses strength after only 2 weeks.⁴³ The differences in reported outcomes by synthetic mesh may be attributable at least in part to their respective time to resorption, which influences its utility as a support scaffold and procedural propensity for adverse events in IBBR.

There are several limitations to the present study. First, this is an observational study as part of an ongoing registry; therefore, the population was not controlled as in interventional trials, there was no control group, and the study was not powered for performance endpoints. Second, due to the multisite nature of this registry study, inherent differences in patient populations and routine surgical practice may exist; additionally, it is not possible to completely discount observational bias given the open-label design. Additionally, the duration of follow-up varied among patients; however, we believe the mean follow-up time of 26.9 months is adequate to capture all relevant data regarding the primary performance endpoint and adverse events. Finally, although patient perception is a highly important metric given the profound psychosocial impact of breast reconstruction, subjective measures of patient perception were not analyzed in the present study and are a potential future area of study.

CONCLUSIONS

This observational study on the use of PDO mesh as a support scaffold in both 2-stage and DTI breast reconstruction demonstrated a favorable adverse event profile and a high rate of procedural success, inclusive of differences in the timing of mesh placement. Future studies should examine these endpoints under a prospective, controlled study design.

DISCLOSURES

Reena S. Sulkar is an independent consultant for SIA and receives hourly compensation. Augustine Y. Chung served as Clinical & Medical Affairs Associate for SIA. Michele K. Hilmer is the Director of Clinical Affairs for SIA. Joshua G. Vose served as Chief Executive Officer for SIA. Frederick J. Duffy is a clinical study investigator and an independent consultant for SIA. He was compensated for case data collection as an investigator and receives hourly compensation as a consultant. Akhil K. Seth is a clinical study investigator for SIA and was compensated for case data collection. Hilton Becker is a clinical study investigator for SIA and was compensated for case data collection. This research and the publication costs were funded in whole by SIA.

SIA owns the PDO mesh technology and manufactures the DuraSorb Monofilament Mesh discussed in this article.

• PDO mesh (Polydioxanone Surgical Scaffold) is a 510k-cleared product (K181094) and is intended for use in the reinforcement of soft tissue where weakness exists.

• PDO mesh has received a general clearance for soft tissue support where weakness exists and has not been determined to be safe or effective for any specific indication or anatomical location.

• The use of PDO mesh in IBBR procedures as discussed in this article has not been approved by the Food and Drug Administration (FDA). The scientific discussion in this article goes beyond the FDA-cleared general use and labeling for soft-tissue reinforcement. This article presents current scientific discourse and data from an observational study only, and safety and effectiveness have not been established for PDO mesh use in IBBR procedures. The following risks are presented by such use: infection of the wound from contaminated mesh, reoperation for mesh removal, seroma formation, inappropriate antibiotics for erythematous mesh reaction/allergy, mechanical mesh failure, and mucocutaneous mesh erosion/extrusion.

There may be additional risks associated with the use of adjunct devices with PDO mesh. As with all implantable devices, there are inherent risks associated with their use; refer to the instructions for use for further information.

• An FDA-approved Investigational Device Exemption clinical trial is currently underway to demonstrate safety and effectiveness for PDO mesh (DuraSorb) use in IBBR procedures (clinicaltrials.gov identifier: NCT04646057)].