• Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
• Patient has or is intended to receive or be treated with an eligible Medtronic product
• Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment
• Patient who is, or will be, inaccessible for follow-up
• Patient with exclusion criteria required by local law
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

• Female between the inclusive ages of 22 and 70 at the time of initial expander surgery
• Scheduled to undergo either unilateral or bilateral mastectomy with immediate 2-stage breast reconstruction
• Is able to understand the study requirements and is willing to provide written informed consent
• Is willing and able to return for all scheduled study visits
• Is pregnant or planning to become pregnant during study participation
• Has a history of failed tissue expansion or breast implantation at the intended reconstruction site
• has a residual gross tumor at the intended reconstruction site
• has been treated for a systemic infection or a local infection at the surgical site that the investigator determines will affect the safety of the subject during breast reconstruction and/or mesh use
• has, as determined by the investigator, unsuitable tissue integrity for immediate 2-stage breast reconstruction
• has undergone previous radiation therapy to the reconstruction site or chest wall
• is scheduled to undergo post-operative radiation therapy at the reconstruction site
• has a Body Mass Index (BMI) < 14 or > 44
• has used nicotine products within 90 days of screening
• is currently taking medications including non-NSAID anti-coagulants, immunosuppressants (including systemic steroids), or other medications determined by the investigator to place the subject at an increased risk of local complications of breast reconstruction
• has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications
• has participated in any other clinical study that the investigator feels may interfere with this clinical study

Inclusion criteria:
• Are ≥18 years of age at screening.
• Have a clinical diagnosis of TED associated with active, moderate to severe TED with the following at screening and Visit 0:
• A CAS ≥ 4 in either eye, and
• Clinical evidence of worsened proptosis with: 1. Proptosis ≥ 18 mm and/or 2. Proptosis ≥ 3 mm increase from participant's baseline (prior to diagnosis of TED), as estimated by the Investigator/assessor
• Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.
• Have onset of active TED within 12 months prior to screening.
• Have documented evidence of detectable anti-TSHR-Ab at screening.
• Are not expected to require immediate surgical intervention and are not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
• Are euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism. Additional inclusion criteria are defined in the protocol. Exclusion criteria:
• Have decreased best corrected visual acuity due to optic neuropathy.
• Have at least a 2-point decrease in CAS or ≥2 mm decrease in proptosis between screening and Baseline assessments in either eye.
• Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening.
• Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of TED.
• Have known autoimmune disease other than TED, that, in the opinion of the Investigator, would interfere with the course and conduct of the study.
• Had previous orbital irradiation or surgery for TED. Additional exclusion criteria are defined in the protocol.