Pid_pc_ e_2013-04

osmed hydrogel expander Plastic Surgery - Product insert data sheet
The use of a template is recommended to accurately mark the position. The template indicates the initial expander size, the recommended size of the pocket, and the final size of the expander after swelling.
Description
The Tissue Expander - Cylinder/Cupola Dental is made of hydrogel, which is a co-polymer of primarily methylmethacrylate and N-vinylpyrrolidone. The hydrogel is contained within a perforated silicone shell to reduce swelling speed.
Through physical absorption of body fluid, an increase of device volume up to approximately 9-12 times (see table) of the original volume is achieved. The final volume will occur after approximately 1 hour to 26 weeks depending on the size. Data about volume and time are product specific as for each single product there is a Position the incision outside the expansion zone and put a small tunnel to the pocket. Regard the edges specifically defined enlargement and swelling time (s. table). Information in the table for final volume will not be exceeded, the duration is a minimum value which can be longer depending on location of implantation, but Preoperativ an i.v. antibiotic-treatment is recommended (e.g.Cephuroxim).
Indications
Size of bag = size of silicone shell = middle line of the template Edge of the swollen expander + projection of the swollen expander = Outer border of the template + projection (also shown on the template) • Preparation for closure of defects after resection of big tumors (e.g. nevi, basalioma, etc.).
General anesthesia or local anesthesia with sedation, depending on the patient’s preference.
• Scar correction, if a primary direct closure is not possible.
Size of bag = size of silicone shell = middle line of the template • Preloading of local flaps e.g. at the forehead.
Exception: by placing the expander under the Galea: • The patient should be positioned on the table in the supine position with the hands fixated to the table • Direct closure of the donor defect of the radialis forearm flap Size of the pocket = Size of the expander after swelling = Outer border of the template.
at the level of the hips, which flexes the elbows and results in slight upper arm abduction.
Preoperativ an i.v. antibiotic-treatment is recommended (e.g.Cephuroxim).
• Desinfection of the skin. If local anesthesia is performed, a circular infiltration of the preparation area • Congenital breast deformities, e.g. Poland´s syndrome, anisomastia, tubular breast deformities (Round).
General anesthesia or local anesthesia with sedation, depending on the patient’s preference.
• In the case of an immediate reconstruction usually after mastectomy, the expander will be introduced into the submuscular pocket through the mastectomy incision.
• Immediate breast reconstruction after skin sparing mastectomy, if sufficient skin and healthy muscle is available and post-operative radiation can be excluded with certainty (Round).
• In the case of a delayed reconstruction, a 5-6 cm long incision is made in the lateral most aspect of • Disinfection of the skin. If local anesthesia is performed, a circular infiltration of the preparation area • Increase of volume after enucleation, especially for secondary treatment, if formally no implant has been • the old mastectomy scar, in order to avoid placement of the expander directly under a fresh wound. inserted. (Alternative to dermis-fat transplant) This will reduce the danger of wound dehiscence as the expander swells.
• Incision should be distant from the implantation site, if possible • Increase of volume after defects e.g. in the face.
• In cases of congenital deformity, the expander is placed through either a peri-areolar or an inframammary incision creating a subglandular pocket. The cut is only little longer than size of the • After traumatic or iatrogenic loss of testicles (Ellipsoid) • Next, the skin is separated from the fascia partly bluntly and partly • At sex change woman to man (Ellipsoid) with cautery until a pocket is created, which is as big as the shell (please use template: middle ring). If possible a small • Cut through the subcutaneous tissue to the pectoralis fascia. At the level of the 5th to 6th rib, the subcutaneous tunnel from insertion to the pocket is built to avoid a pectoralis muscle is spread in direction of the fiber and dissected free. A caudal submuscular • Preparation for closure of cleft palate movement of the expander in direction to the suture.
expander pocket approximately 3 times the size of the expander is created slightly higher than the level of the intended inframammary fold under direct vision using a combination of mono- and bipolar Contraindications
• Exception: by placing under the galea the pocket should have the cautery. Blunt preparation of the submuscular expander pocket is not recommended, as subtle size of the swelled expander (outer ring of the template). Wrinkling The use of this prosthesis is contraindicated in patients who have any of the following conditions: hemostasis is extremely important. The caudal insertion of the pectoralis muscle must be released, however the medial origin at the sternal border should remain intact. If the soft tissue mantle is • Systemic disorders such as uncontrolled Diabetes mellitus • Irrigation of the pocket should be done with Ringer´s solution and laterally very thin, the serratus fascia has to be preserved.
• Intravenous medication of bisphosphonates subtle hemostasis should be done using cautery.
• Irrigation of the pocket should be done with Ringer´s solution and subtle hemostasis should be done • Before the insertion of the expander the wound edge has to be • Local infection in the area to be expanded.
• Before the insertion of the expander, the wound edge has to be painted with iodine solution.
• Thin, atrophied tissue in the area to be expanded.
• The surgeon should change his/her gloves. Only shortly before the insertion the expander is taken • The surgeon should change his/her gloves. Only shortly before the insertion the expander is taken out of the sterile packaging, then inserted into the prepared pocket.
out of the sterile packaging, then inserted into the prepared pocket.
• Damaged tissue caused by radiation therapy.
• Sharp instruments should not be used to insert the osmosis expander in order to avoid the damaging • Sharp instruments should not be used to insert the osmosis expander to avoid the damaging the Patient education and informed consent
• silicone shell. The expander should be placed into the pocket in so that the silicone shell does not The surgical procedures associated with the use of tissue expanders are not without potential complications • A firm subcutaneous closure with single 4x0 or 3x0 vicryl sutures, stitched between subcutis and and risks. The use of this product is an elective procedure. The patient should be counseled prior to surgery fascia. Possibly an external compression or tape bandage is applied - for fixation of the expander at regarding the benefits and possible risks associated with tissue reconstruction using tissue expanders and the right position for the first 3-4 days, to avoid dislocation. A drainage tube generally is not required.
• The base of the expander should be placed at the caudal part of the submuscular pocket at the level It is the responsibility of the individual surgeon to decide the best method by which to counsel a patient prior • A 3-layer wound closure is performed. A drainage tube is recommended.
to surgery. osmed relies upon the surgeon to advise the patient of all potential complications and risks
• After opening of the old suture, the expander rises out of its pocket. The removal is supported by • Three large 20 cm long strips of adhesive dressing are placed on the skin cranially, laterally, and associated with the use of tissue expanders.
subtile pressure to the expander. Big expanders can easily be cut into two or more pieces in order to facilitate its removal through a small incision.
medially around the expander to prevent expander dislocation during the early expansion phase. Instructions for use
Additionally, a Stuttgart belt is worn for 2 weeks postoperatively to prevent cranial migration of the • The pocket should be carefully inspected in order to remove any small gel or silicone pieces that may expander. For 24 hours a compression in favourably.
The implantation of tissue expanders involves a variety of surgical techniques; therefore, the surgeon is best have separated during manipulation and removal of the expander. Then, the pocket is irrigated advised to use the method which his/her own practice and discretion dictate to be best for the patient.
copiously with 0.9% saline or Ringer’s solution.
• Estimating of the created surplus tissue is done by pulling with small hooks. Marking of the resection • After 4 to 6 months, the osmotic expander is replaced by a cohesive silicone gel implant.
Tissue expansion with Rectangle, Cylinder und Round (except breast reconstruction):
area of the tumor or scar is done. After removal of the resection area, a layer wise wound closure is • Use of the old scar in the laterally most aspect. The expander, which has a solid gel consistency, is easily cut into 3 to 4 large pieces in order to facilitate its removal through the small lateral incision Expander implantation has to be performed about 4-15 weeks before the resection or the intended tumor • The submuscular pocket should be carefully inspected in order to remove any small gel and silicone Tissue expansion for breast reconstruction with Round
shell pieces that may have separated during manipulation and removal of the expander, and then the Mark the position of the expander at a suitable location. The use of a template is recommended. The pocket is irrigated copiously with 0.9% saline or Ringer’s lactate solution. A partial capsulotomy may template indicates the recommended size of the pocket, and the final size of the expander after swelling.
The pectoralis major muscle and the overlying soft tissue mantle must be intact and undamaged. be performed to optimize the final implant position in relation to the inframammary fold. A To avoid interference with wound healing due to the tension of the expander as it swells, the skin incision Expander implantation has to be performed 4-6 months before insertion of a breast implant to assure capsulectomy may be necessary when significant capsule fibrosis has occurred.
should be placed relatively distant from implantation site.
• Before insertion of implant another change of cloves.
• A 3-layer wound closure is performed. A drainage tube is recommended.
Recording procedure for tissue expanders
• Any subsequent surgical procedures in the area of placement should be taken with extreme caution as Each expander is supplied with three patient record labels showing the catalog number and lot number for damage to the device could occur. In the event the device is damaged, it must be removed.
Tissue expansion with Pin:
that unit. One of these labels should be attached to the patient’s chart. The date of surgery should be • Careful hemostasis is important to prevent postoperative hematoma formation. Should excessive bleeding persist, it is recommended that the device not be used until the bleeding is controlled.
How supplied
• If a physician treats a hematoma or serous fluid accumulation by aspiration, or a biopsy or lumpectomy is General anesthesia for children. For adults usually a local anesthesia is possible.
The osmed tissue Expander are supplied individually in a sterile and non-pyrogenic double-wrap packaging performed, care must be taken to avoid damaging the expander.
system. The double-wrap system facilitates the preferred method of sterile product transfer from the • The incidence of extrusion of the expander has been shown to increase when the expander has been Mark the position of the expander at a designated location. At use of several expanders foresee sufficient circulating area to the sterile field. Sterility cannot be guaranteed if the double-wrap packaging system has placed in injured areas: scarred, heavily irradiated or burned tissue, crushed bone areas or where severe distance. Pin will double approx. in diameter and length compared to dry state.
been damaged. The Tissue Expanders - Rectangle has been sterilized by gamma irradiation. Resterilization surgical reduction of the area has previously been performed.
A trocar with cannula with inner diameter of 2 mm shall be used as application device. First trocar is used • Excessive fibrous capsular formation or contracture may occur around any expander placed in contact to prepare subcutaneous pocket which corresponds to size of swollen expanders. When trocar is placed This product is for single use only. Sterility, safety and efficacy cannot be assured for damaged devices. Once with soft tissues. The incidence and severity of this occurrence may increase if postoperative local as designated, needle of trocar is removed. Expander is put into cannula of trocar and pushed with the the packaging is damaged a sterile product can not be guaranteed and the device cannot be used for needle. If needle of trocar reaches until the edge, expander safely went through the cannula into tissue/ • The physician should use personal discretion when deciding to use these expanders in patients who pocket. Now trocar can be removed or via the same access next expander can be placed. When Storage, handling and packaging disposal information
implantation is completed access location is closed one- or two-layered with absorbable suture, i.e. 7x0.
Store product at ambient environmental conditions. Follow local governing ordinances and recycling plans Adverse reactions
regarding disposal or recycling of the device packaging materials. Any patient undergoing a surgical procedure is subject to possible unforeseen operative and postoperative After opening at end of respective Pin, expander will come out of pocket. Removal is supported by light Shelf life
complications. Potential reactions and complications associated with the use of the expanders should be Undamaged packages can be used until the expiration date that is printed on the outside of the package. discussed with and understood by the patient prior to surgery. It is the responsibility of the surgeon, and
Then, the pocket is irrigated copiously with 0.9% saline or Ringer’s solution to remove any small gel After this date, the device cannot be used for implantation.
osmed relies on the surgeon, to provide the patient with this information and to weigh the risk/benefit
pieces. Multi-layered wound closure.
Precautions
Adverse reactions which may result from the use of this product include the risks associated with the • It is the responsibility of the surgeon to advise prospective patients or their representatives, prior to medication and methods used in the surgical procedure as well as the patient’s degree of tolerance to any Tissue expansion with Ellipsoid:
surgery, of the possible complications associated with the use of this product.
foreign object placed in the body. The complications may include, but are not limited to, the following: • Pre-existing infection should be treated and resolved before implantation of the expander.
Capsule formation and contracture
General anesthesia for children. For adults usually a local anesthesia is possible. • Lint, dust, talc, surgical glove powder, drape and sponge lint, fingerprints, skin oils and other surface • Postoperative formation of a fibrous tissue capsule around an implanted device is a normal physiologic contaminants deposited on an implant by improper handling may cause foreign body reactions. Strict response to the implantation of a foreign object. Capsule formation occurs in all patients in varying adherence to clean, aseptic techniques should be maintained to prevent contamination of the expander degrees. Capsules range from thin to heavily thickened.
• With local anesthesia, after desinfection of skin, a circular infiltration of the skin shall be done with 1% and possible complications. Surgical instruments and gloves should be rinsed clean of any impurities lidocaine solution. Adrenaline can be added to the local anesthesia at a dilution of 1:200,000 as • Contracture of the fibrous capsule may occur, independent of its thickness. Discomfort, pain, excessive tissue firmness, misshapen expanded tissue, increased palpability and wrinkling of the shell and/or • The silicone elastomer shell may be easily cut by a scalpel or ruptured by excessive stress, manipulation displacement of the expander may occur and may require surgical intervention. In some patients, tissue • The incision for implantation is made outside of the tissue to be expanded, either in the area of the with blunt instruments or penetration by a needle. All expanders should be carefully inspected for firmness may recur subsequent to corrective surgical procedures.
sacrum or at sex change into the labia majora.
structural integrity prior to and during implantation.
Infection
• Then the subcutaneous fatty tissue is separated from the fascia, partly blunt and partly with cauter • Any subsequent surgical procedures in the area of the expander should be undertaken with extreme until a pocket of the size of the expander is achieved.
caution as damage to the expander could occur. In the event that an expander is damaged, it must be • Infection, manifested by swelling, tenderness, pain and fever, may appear in the immediate postoperative period or at any time after insertion of the device. In the absence of classic symptoms, subacute or • The pocket shall be rinsed with Ringer‘s solution and a accurate haemostasis with cauter shall be chronic infections may be difficult to diagnose. If infection does not subside promptly with the appropriate • This expander should not be implanted following any modifications to its original design. An expander treatment, removal of the device is indicated. Infections may result in Toxic Shock Syndrome (TSS). • Before expander can be inserted desinfection solution has to be applied to edge of wound. A retractor which has been damaged, or on which repairs or modifications have been attempted, should not be Symptoms of TSS include, but are not limited to sudden fever, vomiting, diarrhea, fainting, dizziness and/ dipped in desinfection solution is used.
implanted. A standby expander should be available at the time of surgery.
• Subsequent surgeon shall change gloves. Expander is inserted into prepared pocket. A cuff is used to • Do not contact the device with disposable, capacitor-type cautery instruments as damage to the shell of Extrusion of expander/Interruption of wound healing
• Skin necrosis and/or sloughing may result from undue tension of the skin overlying the expander, trauma • To avoid damages at expander sharp instruments must not be used to insert osmosis expander. As Warnings
to the skin flap during surgical procedures or inadequate tissue thickness inhibiting circulation. needed expander is fixated at holes of expander with absorbable suture at surrounding structure. It is the responsibility of the surgeon, and osmed relies on the surgeon, to advise the patient of all potential
Subsequent exposure and/or extrusion of the expander may occur.
• Wound closure with 3-layer suture as well as corium suture with absorbable suture (3/0) for risks and complications associated with the proposed surgical procedure and device, including providing a • Displacement, twisting, fracture or extrusion may occur from improper expander sizing and/or placement, adaptation of deep layered subcutaneous tissue with the fascia at area between healthy tissue to be comparison of the risks and complications of alternative procedures.
e.g., when the expander is too large or the pocket too small or when there has been inadequate expanded and the edge of tumor or scar. Closure of skin with prolene 3/0. For subcutaneous suture At the time of incision closure, care should be taken not to damage the expander with surgical instruments.
preoperative assessment of stresses causing movement to the expander.
shall be applied deeply with absorbable suture 4/0, intracutaneous suture with continuous suture 4/0. • The incidence of extrusion of the expander has been shown to increase when the expander has been Adhesive bandage. A drainage is not necessary. • This is a single use product and should not be reused.
placed in injured areas: scarred, heavily irradiated or burned tissue or crushed bone areas; where severe • Adhesive bandage can be applied circular around the expander to avoid a dislocation of expander • All products with a silicone shell (Round, Rectangle, Cylinder) are for temporary use only. The device surgical reduction of the area has been performed; and where steroids are used in the surgical pocket.
should be removed upon completion of expansion and achievement of the desired result.
Hematoma
• All products without silicone shell (Pin, Ellipsoid) are mainly for permanent use.
• Careful hemostasis is important to prevent postoperative hematoma formation. Should excessive • After cut at the previous suture expander comes out of pocket. Removal is supported by light • If radiation therapy is necessary, radiation should not start earlier than 8 weeks after the implantation of bleeding persist, it is recommended that the device not be implanted until bleeding is controlled.
pressure on the expander. To facilitate a smaller cut bigger expander can be cut into two or more the Tissue Expander as damage to the expander and/or pain may result.
• Gross postoperative hematoma, manifested by enlargement, tenderness and discoloration of tissue may, • Do not insert or attempt to repair a damaged or altered expander.
if untreated, lead to extrusion of the device.
• Pocket has to be rinsed inspected carefully to remove all small pieces of gel which could have been • The action of drugs (examples: antibiotics and steroids) in contact with the device has not been tested by Fluid accumulation
separated at handling or removal of expander. Then, the pocket is irrigated copiously with 0.9% the manufacturer and their use cannot be recommended. Each physician who chooses to use saline or Ringer’s lactate solution.
chemotherapeutic drugs with this expander must assure compatibility of the drug with the expander.
• Excessive postoperative fluid accumulation and transient reaccumulation of fluid around the expander as a result of trauma and after vigorous exercise have been reported.
• In case of use of a penis prothesis, prothesis can be inserted into gained volume.
• Do not introduce or make injections of drugs or other substances into the expander. Injections through Dissatisfaction with cosmetic results
• Wound closure with several layers. For subcutaneous a vicryl suture 3/0 or 4/0 is used and for wound the expander shell will compromise the product’s integrity.
closure a prolene suture 3/0 or 4/0. A drainage is not necessary.
• osmed relies on the surgeon to select the optimum incision and pocket size for the chosen expander • Incorrect expander size, inappropriate scar location or appearance and misplacement or migration of design and projected volume. (Please use template).
expanders may interfere with a satisfactory cosmetic result. These complications are generally associated with the surgical procedure and technique.
• Preoperative evaluation of the expander design and expander size should include allowances for adequate tissue coverage. Pressure, force, tension and other stresses to which the expander site will be Possible reactions to the hydrogel
Until now there are no known reactions caused by hydrogel. • Sepsis, hemorrhage or thrombosis may result from the placement of any foreign object in the body.
Possible reactions to silicone
The issue of the possible relationship between silicone (and other implantable materials) and various
diseases has been the subject of significant scientific debate. Concerns include immunological and
neurological disorders, carcinogenicity and connective tissue disorders.
The report sponsored by the IOM, "Safety of Silicone Breast Implants", released in July 1999 states that
women with silicone breast implants are no more likely than the rest of the population to develop cancer,
immunologic diseases, or neurological problems.
Other
• Thrombosed veins, resembling large cords, have temporarily developed in the area of the device and
have resolved without surgical or medical therapy.
• Pain from an improperly sized and/or placed implant, such as from compression of nerves or interference • Hypertrophic scarring has been reported.
• In single cases it can happen, that the expander grows slower and does not reach its final volume showed in the specifications. As remedy saline water could be injected.
There might be some minute differences in the various translations of the Product Insert Data Sheets due to inherent differences in the languages.
Product evaluation
osmed requires that any complications and/or explantation (prior to the final expansion being achieved)
resulting from the use of this device be brought to the immediate attention of osmed gmbh Ehrenbergstraße
11; 98693 Ilmenau, Deutschland.
Returned goods authorization
Authorization for return of merchandise should be obtained from osmed gmbh, Ehrenbergstrasse 98693
Ilmenau., Germany Phone: +49 3677/668 631. Merchandise must have all manufacturer’s seals intact to be
eligible for credit or replacement. Returned products may be subject to a restocking charge.
Product information disclosure
osmed expressly disclaims all warranties, whether written or oral, statutory, express or implied, by operation
of law or otherwise, including, but not limited to, any implied warranties of merchantability, fitness, or design.
osmed shall not be liable for any direct, incidental or consequential loss, damage or expense, directly or
indirectly arising from the use of this product. No representation or other affirmation of fact, including but not
limited to statements regarding suitability for use, or performance of the product shall be or be deemed to be
a warranty by osmed for any purpose. osmed neither assumes nor authorizes any other or additional liability
or responsibility in connection with this product.
Product order information
For product information or to order directly, contact, the local dealer, which you can find under
www.osmed.biz/contact or osmed gmbh, Ehrenbergstraße 98693 Ilmenau. Phone: +49 3677/668 631
References
Literature references are available upon request from our webside www.osmed.biz/information or
osmed gmbh
Ehrenbergstraße 11
98693 Ilmenau
Germany
Manufacturer
osmed gmbh
Ehrenbergstraße 11
98693 Ilmenau
Germany
Product specification
Comment to labeling
Rectangle
Cylinder
Ellipsoid

Source: http://www.osmed.biz/pdf/PID/PID_PC_2013-04_English.pdf