Becker Continued Access Study
Condition: Breast Reconstruction
Intervention: Mentor Becker 25 Expander/Breast Implant; Mentor Becker 50 Expander/Breast Implant
Intervention description: The breast implant is comprised of the Becker implant and the injection dome/fill tube and has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant.
The Becker 25 Expander/Breast Implant has a silicone gel volume of approximately 25% and saline volume of approximately 75%. The Becker Expander/Breast Implant is available in sizes 150 - 800cc.; The breast implant is comprised of the Becker implant and the injection dome/fill tube and has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant.
The Becker 50 Expander/Breast Implant has a 50% gel volume and a 50% saline volume, so a 400cc implant would nominally have 200cc of saline and 200cc of silicone. The Becker 50 Expander/Breast Implant is available in sizes from 300 to 700cc.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary Breast Reconstruction

Summary:

      While Core Becker patient follow-up is being completed this Continued Access Study is
      designed to enroll patients at a limited rate per month to allow for continued physician and
      patient experience with the device.

      Up to 12 patients per month at sites across the United States will be enrolled in this
      research study. These patients will be implanted with the Becker 25 or Becker 50
      Expander/Breast implant and monitored for 10 years for safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is genetic female, 18 years of age or older

          -  A candidate for primary breast reconstruction for cancer, trauma, surgical loss of
             breast tissue due to mastectomy, malignancy, contralateral post-reconstruction
             symmetry, or congenital deformity, including asymmetry (see Section 6.0 for
             definition)

          -  Signs the Informed Consent

          -  Agrees to return device to Mentor if explant necessary

          -  Agrees to comply with follow-up procedures, including returning for all follow-up
             visits

          -  Patient is a US citizen with a Social Security Number and understands English

        Exclusion Criteria:

          -  Subject is pregnant

          -  Has nursed a child within three months of study enrollment.

          -  Been implanted with any silicone implant including breast implants (e.g. silicone
             artificial joints or facial implants)

          -  Confirmed diagnosis of the following rheumatic diseases or syndromes: SLE, Sjogren's
             syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid
             arthritis, crystalline arthritis, infectious arthritis, spondylarthropathies, any
             other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome

          -  Infection or abscess anywhere in the body

          -  Demonstrates tissue characteristics which are clinically incompatible with implant
             (e.g. tissue damage resulting from radiation, inadequate tissue, or compromised
             vascularity)

          -  Possesses any condition, or is under treatment for any condition which, in the opinion
             of the investigator and/or consulting physicians(s), may constitute an unwarranted
             surgical risk

          -  Anatomic or physiologic abnormality which could lead to significant postoperative
             adverse events

          -  Demonstrates characteristics that are unrealistic/unreasonable with the risks involved
             with the surgical procedure

          -  Premalignant breast disease without a subcutaneous mastectomy

          -  Untreated or inappropriately treated breast malignancy, without mastectomy

          -  Are HIV positive

          -  Implanted metal or metal devices, history of claustrophobia or other condition that
             would make a MRI scan prohibitive

          -  Physician is intending to use the device for tissue expansion only