Table 1.

Inclusion and Exclusion Criteria

Inclusion Criteria	Exclusion criteria
a) Genetic female	a) Has any breast disease considered to be pre-malignant in 1 or both breasts, a history of breast cancer, or an untreated cancer of any type	f) HIV positive (based on medical history)
b) Willingness to follow all study requirements including agreeing to attend all required follow up visits and signs the informed consent	b) Subject lives more than 3 hours travel from the treating surgeon	g) Has been diagnosed with BIA-ALCL
c) Agrees to donate biospecimens to the research study which may not be returned to the subjects	c) Has an abscess or infection	h) Has any medical condition such as obesity (BMI > 40), diabetes, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk, and/or significant postoperative complications
d) Age 30-65	d) Is pregnant or nursing or has had a full-term pregnancy or lactated within 3 months of enrollment	i) Has been implanted with any device that has not been approved by the FDA or equivalent regulatory agency outside the US
	e) Has been implanted with any implantable medical device or silicone implant other than breast implants (except intraocular lenses)	j) Works for any breast implant manufacturer or any of their subsidiaries, the study surgeon, or are directly related to anyone that works for a breast implant manufacturer or any of their subsidiaries