Table 3 Surgical risks to participants

Implant or TE infection requiring removal of the prosthesis (3%, 80% reversible)

Implant or TE infection requiring only antibiotics (3% not severe, 100% reversible)

Mastectomy skin flap problems resulting in removal of implant or TE (2%, 80% reversible)

Mastectomy skin flap problems requiring only conservative treatment and minor debridement in clinic (2% not severe, 100% reversible)

Implant movement requiring additional surgery (3%, 80% reversible)

Visible implant rippling, shape deformity, or poor alignment not requiring correctional surgery (10 to 20%)

Implant rippling, shape deformity, or poor alignment requiring surgery to correct it (10% not reversible)

Seroma or hematoma (1 to 2% not severe, 100% reversible)

Long-term capsular contracture formation (25% develop grades III to IV in 10 years, not reversible)

All need a second surgery for TE exchanged to implant under another general anesthetic

Hypothetical risk of pathogen or disease transmission from the processed human cadaveric donor tissue

All need at least one postoperative TE inflation, on average three inflations that are performed either weekly or biweekly

One-stage method may not be possible for patients who wish to have larger breast sizes postoperative than they had preoperative

All need to wait approximately 3 (±1) months following completion of the TE expansion process prior to the second surgery

Need for two drains rather than one drain per breast

May be discomfort associated with TE inflation

Some reports of increased seroma formation with the use of ADM

Saline leak from the TE may occur and can result in an additional surgery

May be more pain postoperatively with suturing of the ADM down to the chest wall along the inframammary fold

TE may be malpositioned or migrate postoperatively requiring revision surgery prior to TE exchange

There may be more asymmetry between the two sides since there is only surgery to reconstruct the breast mound (versus two opportunities for symmetry correction in the two-stage)

May be additional complications resulting from two surgeries

Less control with the patients selecting the volume of their reconstructed breasts compared to the two-stage TE/I group

May be higher risk of hematoma formation from the need to elevate pectoralis major, serratus major, and rectus fascia

May be more surgical pain associated from the need to elevate pectoralis major, serratus major, and rectus fascia

All need a second surgery for TE exchanged to implant under another general anesthetic