23-MRCO-P JA_106-Breast Implants_Redacted.pdf

Control No: 23-MRCO-P-106

Memorandum for Record – Limiting Competition at or below the Simplified Acquisition Threshold

1. Contracting Activity: Medical Readiness Contracting Office-Pacific, JBLM Health Contracting Branch, Joint Base Lewis-McChord, 673 Woodland Square Loop SE, Lacey WA 98503.

2. Description of Action: In the establishment of a Sole Source BPA; purchase of Sientra Inc., Opus Round Gel Breast implants; Teardrop implants & Breast Tissue Expanders for the Department of Surgery at Madigan Army Medical Center (MAMC) Washington, and Tripler Army Medical Center (TAMC), Hawaii. Total Dollar Value Not-to-Exceed (NTE); $2,500,000.00 for a five (5) year period.

Nature: New Requirement Follow-on Requirement

Contract Vehicle: Purchase Request Number BPAMAMC2023-1 Blanket Purchase Agreement (BPA) Number Order/BPA# against FSS Contract # Order # against Multiple Award IDIQ Contract Name or #

Order # against a single award IDC Contract

Modification # to existing PO/TO/DO/Call Order

Pricing/Contract Type: Fixed Price Time & Materials/Labor Hours Cost Reimbursable Hybrid

Funds: Operations & Maintenance, Army (OMA) Other Funds: _DHP

FY: 2022

Name of Intended Contractor: Sientra Inc.

Street Address: 420 S Fairview Ave Ste 200 City, State, Zip: Santa Barbara, CA

Phone: 724-272-0429 Brand Name Buy: Yes No

3. Description of Services or Supplies: Sientra provides soft durable, smooth shell silicone gel breast implants that have a natural feel. Sientra is the only high-strength cohesive silicone gel implant offered solely to board certified and board eligible plastic surgeons with a minimum of 14 years formalized training. These implants retain their shape over the others, because the gel is thicker than traditional silicone implants. All of their implants have the industry’s most comprehensive 20 year warranty, which is double their competitors'. Sientra's silicone breast implants were clinically shown to have lower long-term complication rates such as rupture, capsular contracture, and re-operation compared to other commonly available FDA-approved breast implants on the U.S. market.

Period of Performance: 1 December 2022 – 30 November 2027 Total Value: $2,500,000.00 (Master BPA limit); $250K (per BPA Call limit).

4. Authority:

FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

5. Reasons for Authority Cited:

Based on comparison with similar products in the marketplace, the surgeon in consultation with the attending surgical team has determined the devices and supplies offered by Sientra, Inc., will best meet the specific patients’ needs for surgery. The surgeons are board certified and trained on the surgical procedures for using these implants and tissue which will provide reduced liability risk, administrative and training time represent that will represent a cost savings to the Government. Increased likelihood of successful surgery, recovery, and quality of life derived from the most appropriate implants and tissues based on the surgeon’s diagnosis is a significant intangible benefit to the Government consistent with the mission of the US Army Medical Command.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to the $ threshold, apply and will be followed, or do not apply due to an exception at

5.202 . (Fill in exception).

Requirement to post justification in accordance with FAR 8.405-6(b)(3), FAR 13.105(c), or FAR 16.505(a)(4)(iii)(A)

Action is NOT a brand name restriction and is under $250K, no posting required

Action is a brand name restriction, under $25K, no posting required Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation.

Action is a brand name restriction over $25K but will not be posted due to exception:

FAR 6.305(f) FAR 8.405-6(b)(3)(iii)(A) FAR 8.405-6(b)(3)(iii)(B) FAR 8.405-6(b)(3)(iii)(C) FAR 16.505(a)(4)(iii(C)

7. Market Research: Market research conducted over the Internet in the past 12 months indicates that this product(s) is commercial in nature. Market research efforts will be continued in order to identify new alternative sources. Any responsible source may express interest and will be considered for future requirements.

8. Other Facts: N/A

9. Technical/Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

10. Contracting Officer Certification/Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon price analysis.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.