CLA-2 OT:RR:CTF:TCM H222137 HvB
Mr. Daniel Hong, LCB
Allergan
2525 Dupont Drive
Irvine, CA 92612
RE: Tariff classification of SeriScaffold™ Surgical Mesh
Dear Mr. Hong:
This letter is in reply to your electronic request for a ruling from U.S. Customs and Border Protection (“CBP”), dated December 9, 2011, on the classification under the Harmonized Tariff Schedule of the United States (“HTSUS”), of the SeriScaffold™ (“SeriScaffold”) surgical mesh. Your submission includes a sample, which will be returned to you, per your request. Your letter was sent to us for a response.
FACTS:
The product is described as a knit, multi-filament bio-engineered silk mesh. It is a sterile, single use mesh available by prescription only and is available in a variety of sizes ready for use in open or laparoscopic procedures. It is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome.
The instant mesh is specifically designed for use in breast reconstruction and augmentation implant procedures. Implant and reconstruction procedures are usually done in one or two stage procedures. In a Stage I reconstruction, after a surgeon removes the breast tissue, “a plastic surgeon places a breast implant. The implant may be put in the space created when the breast tissue was removed or behind the chest muscles to form the breast contour.” A two-stage reconstruction or a two-staged reconstruction (“Stage II”) is described as follows:
Two-stage reconstruction or two-stage delayed reconstruction is the type most often done if implants are used... An implanted tissue expander, which is like a balloon, is put under the skin and chest muscle. Through a tiny valve under the skin, the surgeon injects a salt-water solution at regular intervals to fill the expander over time (about 4 to 6 months). After the skin over the breast area has stretched enough, a second surgery is done to remove the expander and put in the permanent implant. Some expanders are left in place as the final implant.
The two-stage reconstruction is sometimes called delayed-immediate reconstruction because it allows options. If the surgical biopsies show that radiation is needed, the next steps may be delayed until after radiation treatment is complete. If radiation is not needed, the surgeon can start right away with the tissue expander and second surgery.
During a Stage 1 reconstruction, after mastectomy, the tissue expander is rinsed in antibiotic solution and placed into the sub-pectoral pocket. Then, the SeriScaffold is cut to size, rinsed in antibiotic solution, and sutured in place to repair the void between the pectoralis muscle and the chest wall. The SeriScaffold employs a knit pattern that substantially prevents unraveling and preserves the stability of the mesh, which allows the material to be cut in any direction and formed into a variety of shapes. See U.S. Patent Pub. No. 2012/0022646 A1 (publ. Jan. 26, 2012), abstract and paragraphs [0040, 0043]. For example, the surgical mesh can be formed into a sling shape to provide for support for a tissue expander, breast or breast implant. During implant reconstruction, a tissue expander is placed after a mastectomy and expanded until the desired size has been attained. The tissue expander is then filled in accordance with the standard of care.
In a Stage II procedure, the tissue expander is removed and replaced with a breast implant. The timing of the placement of the SeriScaffold is dependent upon the needs of the patient, and therefore, the elapsed time after the SeriScaffold scaffold placement varies. Ibid, paragraphs [0228-0230].
The SeriScaffold’s biocompatible and biodegradable fabric structure allows the mesh to be formed and adapted to engage and support natural breast tissue and breast prostheses. The silk fabric possesses biomechanical properties which facilitate tissue ingrowth including the transfer of properties from the silk mesh to the native tissue, thus ensuring tissue repair or reconstruction. Id., paragraphs [0025, 0038-0039].
ISSUE:
Whether the SeriScaffold surgical mesh is classified under the HTSUS as an article similar to gauze or bandages in heading 3005, HTSUS, or whether it is classified as an orthopedic appliance in heading 9021, HTSUS?
LAW AND ANALYSIS:
Classification of goods under the HTSUS is governed by the General Rules of Interpretation (GRI). GRI 1 provides that classification shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRI may then be applied.
The 2012 HTSUS provisions at issue are:
3005 Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes:
* * *
3005.90 Other:
* * *
3005.90.50 Other
* * *
9021 Orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof:
* * *
Note 6 to Chapter 90, HTSUS, provides, in pertinent part:
For the purposes of heading 9021, the expression “orthopedic appliances” means appliances for:
Preventing or correcting bodily deformities; or
Supporting or holding parts of the body following an illness, operation or injury.
* * *
The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the Harmonized System at the international level. While not legally binding and, therefore not dispositive, the ENs provide a commentary on the scope of each heading of the Harmonized System and are thus useful in ascertaining the classification of merchandise under the Harmonized System. CBP believes the ENs should always be consulted. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (Aug. 23, 1989).
EN 90.21 provides, in pertinent part:
(V) OTHER APPLIANCES WHICH ARE WORN OR CARRIED OR IMPLANTED IN THE BODY, TO COMPENSATE FOR A DEFECT OR DISABILITY
This group includes:
Speech aids for persons having lost the use of their vocal cords as a result of an injury or a surgical operation. …
(2) Pacemakers for stimulating defective heart muscles. …
(3) Electronic aids for the blind. …
(4) Appliances implanted in the body, used to support or replace the chemical function of certain organs (e.g., secretion of insulin.
* * *
Allergan argues that instant products are properly classified as an “orthopedic appliance” under heading 9021, HTSUS, specifically in subheading 9021.90, HTSUS, as an “other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof”.
Articles classifiable in Chapter 90, according to the general EN for Chapter 90, are “characterised by their high finish and high precision.” The EN lists several exceptions to the “high precision” rule, e.g., goggles and magnifying glasses. See also HQ 966555, dated September 9, 2003 (in which we classified ostomy supplies in heading 3926, HTSUS). The surgical mesh is not included in these exceptions, and moreover, consists of a piece of raw silk fabric. Thus, we do not believe that the instant article is characterized by high finish and high precision. Although the surgical mesh may have sophisticated properties and uses, it is nonetheless substantially dissimilar to instruments, appliances, and other apparatuses of Chapter 90.
In addition, heading 9021, HTSUS, does not describe the surgical mesh because the SeriScaffold is not an “other appliance… worn or carried, or implanted in the body, to compensate for a defect or disability” of heading 9021. EN(V) for 90.21 explains that these articles are precision electronic devices that are designed to replace or assist a lost function engendered by a defect or disability, such as a hearing aid, pacemaker, electronic aids for the blind or deaf. The instant article consists of a piece of silk fabric which can be cut to size, during a surgical procedure for tissue repair and support, is absorbed into the body, and cannot be reused.
Furthermore, the subject merchandise does not meet the definition of "orthopedic appliances" articulated by Note 6 to Chapter 90 regarding heading 9021, HTSUS. The product must be an appliance for “preventing or correcting bodily deformities” or for “supporting or holding parts of the body following an illness, operation or injury.” The SeriScaffold neither meets these terms nor resembles the named orthopedic appliances of heading 9021, e.g., “crutches, surgical belts and trusses.” The instant merchandise consists of a surgical mesh that allows for the repair and formation of breast tissue following a mastectomy. While the surgical mesh does provide “support”, it is not in the context similar to the examples of orthopedic appliances listed in the EN and those articles which we have classified as such in heading 9021, HTSUS. See, e.g., New York Ruling Letter (“NY”) N186215, dated October 25, 2011 (arm and leg splints), NY N166443, dated May 31, 2011 (personal sound amplifier), NY N221061, dated July 10, 2012 (gastro electro stimulation system), and NY N207478, dated March 26, 2012 (implantable drug infusion pump system). Rather, the surgical mesh is designed to repair tissue defects during surgical procedures by aiding the growth of natural tissue.
CBP has had the occasion to classify a substantially similar product. In Headquarters Ruling Letter (“HQ”) H030420, dated August 4, 2009, we classified two Parietex surgical mesh devices composed of woven polyester fabric with specialized knit technology for use during hernia repair surgery. Like the instant SeriScaffold, the Parietex is cut to shape to fit within the surgical area, is designed to promote tissue integration, is sterilized, and is sold ready for medical use. In addition, similar to the instant surgical mesh, the Parietex provides support to tissue. We classified Parietex in heading 3005, HTSUS, which provides for “wadding, gauze, bandages and similar articles...”
The instant article is a biocompatible textile mesh that is implanted in the body to repair breast tissue deficiencies or to support breast prostheses. The SeriScaffold’s silk fabric possesses bio-mechanical properties of connective tissue and is designed to withstand unraveling after being cut into shape. Like the Parietex surgical mesh, the SeriScaffold surgical mesh primarily functions to repair the void between the pectoral muscle and chest wall.
CBP has defined a bandage as a piece of material applied to a body part to make a compression, absorb drainage, prevent motion, retain surgical dressing, or lend support to a wound. See New York Ruling Letter (“NY”) I84715, dated August 8, 2002 and HQ 966637, dated October 22, 2003. In HQ 962172, dated May 5, 1999, we declined to classify a magnetic bandage in heading 3005, HTSUS, through application of ejusdem generis because it could not be placed on an open wound and it therefore lacked common characteristics of the articles of heading 3005.
Here, one is explicitly directed to avoid placing this item on an open wound. Furthermore, this heading is limited to items which are for ‘medical, surgical... purposes.’ The claimed relief of aches and pains provided by this product does not rise to the level of a medical treatment. Thus it is not properly classified in heading 3005, HTSUS.
Ibid. In contrast, the instant SeriScaffold is sutured to an open wound to address tissue deficiencies and serve as a scaffold for tissue generation during implant procedures. Thus, SeriScaffold functions similarly to a bandage since it lends supports to interior surgical wounds, is sold ready for use in retail sale, and is applied to promote tissue repair. Accordingly, the SeriScaffold surgical mesh is classified under heading 3005, HTSUS.
HOLDING:
The SeriScaffold is properly classified under subheading 3005.90.50, HTSUS, which provides for: “Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes: other: other“. The general, column one rate of duty is “Free”.
Duty rates are provided for the internal advice applicant’s convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at www.usitc.gov.
Sincerely,
Ieva K. O’Rourke, Chief
Tariff Classification & Marking Branch