During treatment, very low doses of Botox® Cosmetic are administered via a few tiny injections directly into the muscles responsible for frown lines between the brows. By blocking the release of a chemical that causes them to contract, Botox® Cosmetic enables them to relax. The effects are very localized and, when administered by an experienced injector, do not affect your ability to smile, laugh, or otherwise show expression. Botox® Cosmetic is the only product of its kind that has been approved for use in this area.
As with with plastic surgery or any other cosmetic procedure, what you are paying for is an injector who has experience and a proven track record of beautiful results. If you're looking for a precise estimate of what it will cost to achieve your Botox goals, I encourage you to meet with a board-certified plastic surgeon or dermatologist for an initial consultation.
Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Richard Clark, a plastic surgeon from Sacramento (CA), was the first to document a cosmetic use for botulinum toxin. He treated forehead asymmetry caused by left sided forehead nerve paralysis that occurred during a cosmetic facelift. Since the injured nerve could possibly regenerate by 24 months, a two-year waiting period was necessary before definitive surgical treatment could be done. Clark realized that botulinum toxin, which had been previously used only for cross eyed babies and facial tics, could also be injected to smooth the wrinkles of the right forehead to match her paralyzed left. He received FDA approval for this cosmetic application of the toxin and successfully treated the person and published the case study in 1989.
Botox should only be injected with sterile instruments in a doctor's office or a medical spa — not at Botox parties at your local nail salon or neighbor's living room. Botox injection is usually performed with some local anesthesia or a numbing cream. You may feel some minimal discomfort from the shot, but today's needles are so thin and fine that the procedure is often painless. Depending on the extent of treatment, the procedure can take anywhere from a few minutes to 20 minutes.
It's also not approved by the U.S. Food and Drug Administration (FDA) for depression, not that that stops doctors from prescribing it that way. Such off-label use of Botox, like that of any FDA-approved drug, is legal in the U.S. That's because once a drug has been approved by the FDA for a condition, licensed physicians are legally allowed to prescribe it for any medical issue they think it could benefit, regardless of whether it's been proved to work for that condition.
Significant improvements compared to placebo in the primary efficacy variable of change from baseline in daily frequency of incontinence episodes were observed for BOTOX® (100 Units) at the primary efficacy time point at week 6. Increases in maximum cystometric capacity and reductions in maximum detrusor pressure during the first involuntary detrusor contraction were also observed. These primary and secondary endpoints are shown in Table 23.
The most frequently reported adverse reactions following injection of BOTOX® for Chronic Migraine vs placebo include, respectively: neck pain (9% vs 3%), headache (5% vs 3%), eyelid ptosis (4% vs < 1%), migraine (4% vs 3%), muscular weakness (4% vs < 1%), musculoskeletal stiffness (4% vs 1%), bronchitis (3% vs 2%), injection-site pain (3% vs 2%), musculoskeletal pain (3% vs 1%), myalgia (3% vs 1%), facial paresis (2% vs 0%), hypertension (2% vs 1%), and muscle spasms (2% vs 1%).
The bacterium can also be found in the intestinal tracts of mammals and fish and in the gills and organs of crabs and other shellfish. Such naturally occurring instances of Clostridium botulinum bacteria and spores are generally harmless. Problems only arise when the spores transform into vegetative cells and the cell population increases. At a certain point, the bacteria begin producing botulinum toxin, the deadly neurotoxin responsible for botulism.
In the before and after picture of my mom's Botox treatment, my mom paid $350 and was charged per area. She chooses reputable physicians that may be slightly more expensive than average, but have good patient reviews and are well-trained and skilled. To her, it is more worth it to have a doctor who knows how to cater the right technique to her skin issues than to have a doctor who injects her with a certain quantity of Botox but with poor or ineffective technique. This doesn't mean that the more expensive a doctor is, the better he or she will be. It just means that similar to how you would hesitate if the treatment is really expensive, you should also hesitate if the Botox treatment is really inexpensive. Good Botox requires a skilled hand and this is especially important since Botox is a treatment that can definitely be botched.
The co-primary endpoints were the average of the change from baseline in modified Ashworth Scale (MAS) ankle score at Week 4 and Week 6, and the average of the Physician Global Assessment of Response (CGI) at Week 4 and Week 6. The CGI evaluated the response to treatment in terms of how the patient was doing in his/her life using a 9-point scale from -4=very marked worsening to +4=very marked improvement).
Remember that the skill of the injector is extremely important when considering Botox injections. Because Botox can have some very obvious and embarrassing side effects like drooping eyelids, blurry vision, and excessive bruising around the injection site, it's important to consult with an experienced injector. Unlike dermal fillers which can be melted away with a follow-up injection of hyaluronidase, there's not much you can do about a bad Botox experience other than wait it out.
The ideal needle to use is a 30G or 31G, half-inch needle. Longer needles are problematic as they encourage deeper injections, which can increase the risk of muscle weakness, and most of the side effects such as neck pain stem from muscle weakness. Perseverative-free normal saline is the only diluent that should be used. There is a case study of a patient who died when onabotulinumtoxinA was mixed with a local anesthetic agent. The pivotal trial established an effective dose using 2 mL/100 units of onabotulinumtoxinA. A fact that is often overlooked is that the mean dose in the trial was 165 units. The patients all received 155 units with a fixed dose, fixed-site injection protocol, and an option of an additional 40 units to follow the pain. This resulted in a mean dose of 165 units, which is the standard that should be used to achieve the efficacy results reviewed above.
Allergan is Bold for Life. We build bridges, forging powerful connections with customers, patients, and each other. We act fast, seizing opportunity when we see it. We power ideas, innovating throughout our organization and advancing the best ideas, regardless of source. And, we drive results, taking initiative and carving new paths that lead to better outcomes. To fuel our culture, we need bold thinkers. People with integrity. When you work at Allergan, your boldness is encouraged.
Each vial of BOTOX contains either 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride; 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride; or 200 Units of Clostridium botulinum type A neurotoxin complex, 1 mg of Albumin Human, and 1.8 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.
BOTOX injections for migraines is a preventative treatment, rather than treating the condition with pain medication. It was FDA-approved in 2010 and is considered an appropriate treatment for adults who experience migraine headaches more than 15 days per month, for more than three months. The product blocks the release of certain brain chemicals, and it is believed that blocking these chemicals limits the nerve signals causing pain.
Children do very well after having this procedure in our clinic and are not upset when they leave. We rarely use sedation. We use distraction and a quick injection method instead. In rare cases, localization of a muscle may be needed using an electromyograph (EMG) machine or electric stimulator. If this is needed we will discuss this before scheduling the injections.
As part of the settlement, Allergan agreed to plead guilty to one criminal misdemeanor misbranding charge and pay $375 million. The company acknowledged that its marketing of Botox led to off-label uses of the drug. Allergan also agreed to pay $225 million to resolve civil charges alleging that the marketing of Botox had caused doctors to file false reimbursement claims, though Allergan denied wrongdoing. The company said in a statement that the settlement was in the best interest of its stockholders because it avoided litigation costs and "permits us to focus our time and resources on ... developing new treatments."
Table 14 presents the most frequently reported adverse reactions in a placebo-controlled, double-blind post-approval 52 week study with BOTOX 100 Units (Study NDO-3) conducted in MS patients with urinary incontinence due to detrusor overactivity associated with a neurologic condition. These patients were not adequately managed with at least one anticholinergic agent and not catheterized at baseline. The table below presents the most frequently reported adverse reactions within 12 weeks of injection.
In a double-blind study of 123 adults with regular, chronic migraine, the adults receiving botulinum toxin type A experienced fewer migraine attacks each month. In addition, attacks they did experience were less intense, of shorter duration, and required less treatment than adults who did not receive Botox injections for migraine. These injections were also well-tolerated in adults experiencing migraine with and without aura.
That said, there are a few things I'd make sure everyone knows before trying it. For one thing, it can be pretty painful. I have a pretty high pain tolerance, but getting 30 to 40 shots every three months is pretty rough — it feels a bit like getting tattooed with a bee's stinger, but once the needle is out of your skin, the pain goes away, and if it works for you, it's worth it. It's also important to know that it can take some time to work. The first treatment barely worked at all for me, and the second round took a few weeks. If you're going to try it out, be patient.
It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.