G Spot Amplification™ or G-Shot is not an approved use of collagen by the FDA and is an off-label use. However, collagen injection into the vagina (trans-vaginal or trans-urethral) has been performed for many years for the treatment of a condition called intrinsic sphincter deficiency (ISD) which primarily affects elderly women. In ISD the internal urethral sphincter remains open and these women continuously leak urine. These techniques are also used for the treatment of stress urinary incontinence (involuntary loss of urine with laughing, coughing, sneezing, exercising etc). The G-Shot procedure is an off label use. Multiple ”fillers“ or bio-injectables are used as bulking agents to close the internal sphincter and provide continence. There are numerous clinical investigational studies reporting on the injection of collagen substances, fillers and bio-injectables into the vagina for conditions indicated above. The majority of the studies show that the techniques are safe and rarely have complications. Despite the stringent donor screening involved in the preparation of the collagen, the transmission of infectious agents cannot be entirely excluded. Collagen injections are contraindicated in patients with histories of collagen vascular disease, autoimmune disease, allergies to collagen or to lidocaine, the anesthetic injected along with the collagen, or patients with a history of severe allergic reaction or anaphylaxis, serious medical conditions including bleeding disorders, current anticoagulation, immunocompromised status, pelvic prolapse, neurogenic bladder, interstitial cystitis, acute urethritis, acute cystitis, acute genitourinary infection, bladder outlet obstruction, undiagnosed urinary tract dysfunction, or an inflamed or infected vaginal mucosa. Product should not be used in patients with previous bladder neck surgery or those having received radiation therapy. Trace amounts of polymyxin B sulfate, bacitracin and/or gentamicin may be present in the collagen preparation. Patients who may be allergic to these antibiotics should be appropriately managed. Pregnant women should wait until the postpartum period to have collagen treatments. Any sign of swelling, itching or redness or other occurrences at the procedure site should be reported to your surgeon.

Risks not necessarily related to allergic reactions include uncomplicated urinary tract infections, urinary retention, and urethral irritation. Uncommon complications such as periurethral pseudocyst formation and urethrovaginal fistula also have been reported. Other complications seen include bleeding, infection, abscess formation, open sores, scarring and lumpiness, which may persist over the amplification area. However, long term (> 1 year) data are lacking. Please see consent form for a comprehensive list of the risks and complications associated with the use of this product.

We have included a list of some of the scientific research articles on the conditions listed above (ISD, SUI) where collagen injection into the vagina is used. You can also go to the website www.pubmed.org and type in the browser collagen treatment of stress urinary incontinence. By so doing you can view abstracts of peer reviewed scientific articles.

It is important that every patient is informed of the risk, complications and alternatives and therefore we have included an actual consent form that requires a patient to read it, understand it and sign it before the procedure.

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