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Indications, Safety and Warnings

Tactra™ Malleable Penile Prosthesis

Go to Tactra™ Malleable Penile Prosthesis Product Page

Brief Summary Document - HCP

Product

Tactra™ Malleable Penile Prosthesis - IFU number 51519609-01A

Rx Statement

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.  

The device is intended to be implanted by, or under the supervision of, a skilled physician with experience in urological implant surgery. 

Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions. 

Intended use/Indications for use

The Tactra Penile Prosthesis is designed to provide penile rigidity and malleability, and the device can be placed in either an erect or a concealed position.  

The Tactra Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are determined to be suitable candidates for implantation surgery. 

Contraindications

  • The implantation of this device is contraindicated in patients who have active urogenital infections or active skin infections in the region of surgery.  
  • The implantation of this device is contraindicated in patients whose total intracorporal length is not within the range of 14 cm to 27 cm.  
  • The implantation of this device is contraindicated in patients whom the physician determines to be poor candidates due to risks associated with open surgical procedures and/or the patient’s medical history (physical and mental conditions), or with sensitivity to silicone materials and/or patients who are allergic to device materials.  
  • The implantation of this device is contraindicated in patients who require repeated endoscopic procedures beyond routine cystoscopy.  
  • Patients who have compromised tissue and as a result cannot withstand constant intracorpora pressure should not be implanted with the Tactra Penile Prosthesis. 

Reuse Warning

For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. 

Warnings

  • The non-malleable zone of each cylinder (see Figure 3 in IFU) should be positioned proximally of the penoscrotal junction. Failure to do so may result in sub-optimal concealed positioning. 
  • Failure to evaluate and promptly treat erosion may result in a substantial worsening of the condition leading to infection and loss of tissue.  
  • Proper sizing of the device is critical to a successful outcome. Improper measurement, inappropriate cylinder size selection, or malpositioning of the cylinders within the corpora cavernosa may result in migration, erosion, extrusion, buckling of the cylinders, or reduced cylinder life. 

Precautions

Surgery Related

  • Direct contact of surgical instruments with the prosthesis may result in damage, rendering it unsuitable for implantation.  
  • During insertion, do not over bend cylinders beyond their natural U-shape as it may damage the prosthesis and shorten its product life.  
  • Do not trim the distal section of the cylinders beyond the lowest indicated graduation on the proximal section, or the RTEs. Doing so will compromise the device integrity.  
  • Trim the proximal section with a fresh scalpel blade to ensure a clean, straight cut.  

Device Related

  • Implantation of a penile prosthesis that has been in previous contact with or contaminated by body tissue or fluid, regardless of cleaning, or sterilization, is prohibited.  
  • The “0” (zero) RTE is required to be attached to fulfill the indicated length on the cylinder. The physician may utilize the optional 0.5 cm and 1 cm RTEs to provide additional length as needed. Trimming should not take place beyond the lowest indicated graduations to ensure optimal RTE fit and to avoid trimming too close to the internal cable.  
  • Markings are present to indicate the transition from the proximal section to the distal section. The total length of RTEs and the proximal rigid section of the cylinders (non-malleable zone) should not extend beyond the penoscrotal junction. See Figure 3 (in the IFU) for guidance on the malleable zone.
  • The Tactra Penile Prosthesis is designed to be implanted as a pair of matched cylinders. A single implanted cylinder may not be adequate to achieve sexual intercourse and may have an adverse effect on the performance or reliability of the device. This in turn can lead to revision surgery. 

Patient Related

  • Uncircumcised patients may have an increased risk of postoperative complications with the subcoronal approach. Surgeons may wish to discuss performing a circumcision to reduce the risks of post-operative complications associated with this approach.  
  • Patients must have sufficient strength and dexterity to position the device.  
  • The risk of surgical revision or device removal is common to all devices. Generally, surgical revision or removal of penile prostheses is performed to address other complications. However, the patient may elect to have the device removed due to patient dissatisfaction unrelated to safety or efficacy. Removal of an implanted prosthesis, for any reason, without timely re-implantation of a new prosthesis may substantially complicate re-implantation or make it impossible. 

Adverse events

Known and potential complications include the following:  

  • Allergic reaction  
  • Dehiscence  
  • Device inadequate for sexual activity  
  • Device inadequate for concealed positioning  
  • Device migration  
  • Edema  
  • Erosion  
  • Extrusion  
  • Fistula  
  • Hematoma  
  • Infection  
  • Inflammation  
  • Ischemia  
  • Mechanical malfunction (fracture of the prosthesis, or breach of the outer silicone layer)  
  • Necrosis/gangrene  
  • Perforation  
  • Post-operative hemorrhage  
  • Prolonged or intractable pain and discomfort  
  • Silicone particle migration  
  • Unintended tissue, muscle, vessel, or nerve injury  
  • Unretrieved device fragments  
  • Urinary obstruction  
  • Urinary retention

The adverse events listed above may necessitate surgical revision or removal of the prosthesis.  

Operational instructions are outlined below to guide the implanting physician through the procedure. These instructions will aid in reducing the possibility of any complications causing a prolonged procedure. 

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.  

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