G Spot Amplification™ or G-Shot is not an approved use of Fascian® or 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 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. 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.
You can 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.
Nothing contained on this website is intended to represent a promise, guarantee or warranty that any patient who undergoes the G-Spot Amplification/G-Shot will achieve a particular result. Individual results do vary, and no responsibility is assumed for failure to achieve a desired result. The use of collagen in this procedure is an ‘off label’ use, and utilization of this product, no promise or representation, guarantee or warranty regarding its use, benefit or other quality is made. No representations that the use of this product and this procedure is approved by the FDA or any other agency of the federal or state government is made.
CONSENT VAGINAL SUBMUCOSAL/SUBURETHREA COLLAGEN (particulate fascia known as FASCIAN™) INJECTION (THE G-SHOT®; G-SPOT AMPLIFICATION®) AND ADMINISTRATION OF ANESTHESIA
A. CONSENT FOR PROCEDURE
I have received information about my condition, the proposed treatment, alternatives, and related risks. This form contains a brief summary of this information. I have received an explanation of any unfamiliar terms and have been offered the opportunity to ask questions. I understand I may refuse consent and I GIVE MY INFORMED AND VOLUNTARY CONSENT to the proposed procedures and the other matters shown below. I also consent to the performance of any additional procedures determined in the course of a procedure to be in my best interests and where delay might impair my health.
1. I authorize Dr. __________________ to treat my condition, including performing further diagnosis and the procedures described below, and taking any needed photographs.
2. I understand the proposed procedure(s) to be: vaginal submucosal/subureathral collagen (particulate fascia known as FASCIAN™) injection (The G-Shot®; G-Spot Amplification®).
4. I understand the risks associated with the proposed procedure(s) to be:
Bleeding
Infections
Urinary retentions
Accelerated collagen re-absorption
No effect at all
Allergic reactions
Constant awareness of the G-Spot
A sensation of always being sexually aroused
Constant vaginal wetness
Mental preoccupation of the G-Spot
Alteration of the function of the G-Spot
Sexual function alterations
Hematoma (collection of blood)
Collagen site ulceration
Urethral injury (tube you urinate through)
Urinary retentions
Hematuria (blood in urine)
UTI (Urinary Tract Infection)
Urinary Urgency (feel like you always have to urinate)
Urinary Frequency
Increased/worsening nocturia (waking up several times at night to urinate)
Change in urinary stream
Urethral vaginal fistula (hole between urethra and vagina)
Vesico-vaginal fistula (hole between bladder and vagina)
Dyspareunia (Painful intersourse)
Need for subsequent surgery
Alteration of vaginal sensations
Scar formation (vaginal)
Urethral stricture (abnormal narrowing of the urethra)
Local tissue infarction and necrosis
Yeast infections
Vaginal Discharges
Spotting between periods
Bladder Pains
Overactive Bladder (OAB)
Bladder Fullness
Exposed Material
Pelvic Pains
Pelvic Heaviness
Collagen injected into the bladder or urethra
Erosion
Fatigue
Damage to nearby organs including bladder, urethra and ureters
Alteration of bladder dynamics
Post-operative pain
Prolonged pain
Intractable pain
Alteration of the female sexual response cycle
Failed procedure
Varied results
Psychological alterations
Relationship problems
Sex life alteration
Decreased sexual function
Possible hospitalization for treatment of complications
Lidocaine toxicity
Anesthesia reaction
Embolism
Depression
Reactions to medications including anaphylaxis
Nerve damage
Permanent numbness
Slow healing
Swelling
Sexual dysfunction
Allergy to Collagen material
Collagen migration
Nodule formation
4. I also understand that there may be other RISKS OR COMPLICATIONS, OR SERIOUS INJURY from both known and unknown causes. I am aware that the practice of medicine and surgery is not an exact science and I acknowledge that no guarantees have been made to me concerning the risks of the procedure.
5. I understand the alternatives to the proposed procedures and the related risks to be: do nothing.
B. CONSENT FOR ANESTHESIA
1. When local anesthesia and/or sedation is used by the physician on page one, Section A1:
I consent to the administration of such local anesthetics as may be considered necessary by the physician in charge of my care. I understand that the risks of local anesthesia include: local discomfort, swelling, bruising, allergic reactions to medications, and seizures.
C. PATIENT CERTIFICATION:
By signing below I state that I am 18 years of age or older, or otherwise authorized to consent. I have read or have had explained to me the contents of this form. I understand the information on this form and give my consent to what is described above and to what has been explained to me.
_________________________________________ / _______________
SIGNATURE OF PATIENT and DATE
D. PHYSICIAN ATTESTATION
I have explained the procedure(s), alternative(s) and risks to the person or persons whose signature is affixed above. The patient has verbally communicated to me that they understand the contents of this form.
_________________________________________ / _______________
SIGNATURE OF PHYSICIAN OR DESIGNEE OBTAINING CONSENT and DATE
E. INTERPRETER ATTESTATION (when applicable)
I have provided translation to the person(s) whose signature(s) is affixed above.
_________________________________________ / _______________
SIGNATURE OF INTERPRETER and DATE
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If you would like more information about the G-Shot procedure or any of the other services offered by Dr. Huertas, please contact his office at 972-279-9000 and his capable staff will guide you through the process. Even better, for more personalized information specific to your individual needs, contact us or call today to schedule a consultation.
The Dallas Center for Laser Vaginal Rejuvenation
Otoniel Huertas, MD
2540 N Galloway Ave.
Bldg 3, Suite 304
Mesquite, TX 75150
972-279-9000
Contact us or call to schedule your personal consultation.