Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
June 1, 2015
Frances E. Harrison, RAC
Vice President, Quality, Regulatory and Tissue Services
95 Corporate Drive
Bridgewater, NJ 08807
Re: Surgical Mesh
Refer to CMS # 459704
Dear Ms. Harrison:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Strattice Reconstructive Tissue Matrix in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201 (h) of the Act, 21 U.S.C. § 321 (h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body.
FDA has reviewed your firm's website, http://www.lifecell.com/health-care-professionals/lifecellproducts/stratticetm-reconstructive-tissue-matrix/ and determined that the Strattice Reconstructive Tissue Matrix is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351 (f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The Strattice Reconstructive Tissue Matrix is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution a device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
Specifically, the Strattice Reconstructive Tissue Matrix was cleared under K082176 as "LTM-BPS Surgical Mesh" for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissues in plastic and reconstructive surgery. The LTM-BPS is intended for single patient, one time use only.
However, your firm's promotion of the Strattice Reconstructive Tissue Matrix provides evidence that the device is intended for breast reconstructive surgery applications, which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval. Examples include, but may not be limited to:
Breast Reconstruction Tab
• "Strattice Tissue Matrix is used by surgeons in soft tissue repair, including breast reconstruction, where existing tissue is weak or inadequate. "
• "Strattice Tissue Matrix helps the surgeon to support and position the breast in the desired location."
• Presentation "How Strattice Tissue Matrix May Help" with common surgical challenges, including that for a "[t]ight breast pocket," Strattice "[p]rovides for a larger and more elastic breast pocket''
Breast Plastic Surgery Tab
"Strattice Tissue Matrix is a tool to assist surgeons in addressing the challenges encountered in mastopexy augmentation and revisionary procedures due to weak or inadequate issue. By reinforcing thin/weak tissue, Strattice may help the surgeon
o Supporting and positioning the breasts in the desired location
o Providing additional tissue support following capsule resection
o Redefining the fold location by supporting the fold repair inferiorly or laterally
o Providing support to the medial repair giving the surgeon control over the breast pocket size and location
This indication falls outside of the Strattice Reconstructive Tissue Matrix's intended use because surgical mesh has not been cleared or approved for use in breast reconstructive surgery applications. The specific breast reconstructive surgery indication is a major change in the intended use of a surgical mesh cleared with a general soft tissue reinforcement indication regulated by 21 CFR 878.3300.
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Our office requests that LifeCell Corporation immediately cease activities that result in the misbranding or adulteration of the Strattice Reconstructive Tissue Matrix, such as the commercial distribution of the device for the uses discussed above.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
Your firm's response should be sent to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Inspections Support Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the identification number CMS # 459704 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Ms. LaShanda Long, Chief, Surveillance and Enforcement Branch I, Division of Premarket and Labeling Compliance, Office of Compliance, at 301-796-5770 or 301-847-8137 (fax).
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm's responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
Jan Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and