G Spot Amplification™ or G-Shot™ or G-Spot Augmenetation (GSA) is not an approved use of collagen or other fillers or bio-injectables such as hyaluronic acid/hyaluronate or calcium hydroxylapatite 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) typically seen after preganancy. The G-Shot™ procedure or GSA 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 had 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.