More on Using Singulair Treatment for Capsular Contracture

Updated 3/2017 -- photos and all links (except to my own posts) removed as many no longer active.

Previously I reviewed the literature on the off-label use of zafirlukast (Accolate) and montelukast (Singulair) for the treatment of capsular contracture.  The recent issue (May/June 2010) of the Aesthetic Surgery Journal has an article (full reference below) on the use of Singulair for capsular contracture (CC).

Huang and Handel’s article reviews the literature, noting some articles I missed.  Their study is a small (17 patients, 4 with bilateral CC for a total of 21breasts treated with Baker’s Grade II or greater CC).  All of their patients were informed of possible risks associated with the off-label application of Singulair before being prescribed 10 mg of Singulair for 90 days and instructed to massage their breasts twice daily.

Unlike Accolate, the adverse event profile of Singulair is comparable to placebo, with the most common side effects being headache (18.4% vs 18.1%), influenza-like symptoms (4.2% vs 3.9%), abdominal pain (2.9% vs 2.5%), cough (2.7% vs 2.4%), and dyspepsia (2.1% vs 1.1%).

Follow-up of patient compliance and treatment results was obtained by a combination of chart review and a standardized telephone questionnaire.  Telephone interviews were used to determine the actual duration and dose of Singulair taken by the patient and whether the patient noted improvement, no change, or worsening of contracture.

The authors note that this is only a preliminary study show without a well-matched population of negative controls.  That said:

Our follow-up data showed that in two (11%) patients, the CC worsened, three (16%) patients had no change, five (26%) improved, and seven (37%) completely resolved.

As for adverse effects from Singulair:

Only one of our patients reported any side effect (fatigue). All other patients tolerated the treatment without any problems.

Their conclusions are (bold highlight is mine):

Our article presents preliminary findings on the off-label use of Singulair for CC. The drug is well tolerated with minimal side effects; therefore, we recommend its application in patients with CC. There was a greater response in breasts with mild CC, so a course of Singulair should be started early. Because it prevented recurrence in two patients with previous severe contracture, we recommend prophylactic prescription in patients with a history of recurrent contracture. In patients who already have moderately advanced CC, Singulair is unlikely to reverse symptoms to the degree that revision can be avoided.

This is a topic I will continue to follow with interest.


REFERENCE

Catherine K. Huang, Neal Handel; Effects of Singulair (Montelukast) Treatment for Capsular Contracture; Aesthetic Surgery Journal May/June 2010 30: 404-408; doi:10.1177/1090820X10374724

Lipodissolve “Too Good to be True”

Updated 3/2017 -- all links (except to my own posts) removed as many no longer active. and it was easier than checking each one.

I have long been skeptical of Lipodissolve claims.  Patients would ask about the injections that dissolve the fat without surgery.  How it worked?  How safe is it?  Do you do it?  Do you know anyone who does?

The FDA has finally issued a warning

On April 7, 2010, FDA announced it had sent warning letters to six medical spas in the United States—and a cyber letter to a company in Brazil—for making false or misleading statements on their Web sites about drugs used in the procedure, or for otherwise misbranding lipodissolve products.

The U.S. medical spas receiving warning letters make various unsupported claims about lipodissolve, such as assertions that the products used in lipodissolve

• are safe and effective
• have an outstanding safety record
• are superior to other fat-loss procedures, including liposuction

Notice the “unsupported claims” phrase.  I have never been able to find any good articles regarding lipodissolve so that I could intelligently answer questions regarding it. 

Lipodissolve is a procedure where the patient receives a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body.   This procedure is also known as injection lipolysis, lipozap, lipotherapy, and mesotherapy.

The drugs most regularly used in the lipodissolve injection procedures are phosphatidylcholine and deoxycholate (commonly called PC and DC, respectively).  Other ingredients may also be used, including drugs or components of other products such as vitamins, minerals, and herbal extracts.

None of the drugs or products used have been approved by the FDA for fat dissolving or fat removal.

The FDA wants any potential lipodissolve patients to be aware:

• None of the drugs/products used in the procedure have been evaluated or approved by the FDA.
• The FDA is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination.
• The safety of the substances used in lipodissolve, when used alone or in combination, is unknown.
• The FDA is not aware of clinical studies to support medical uses of lipodissolve.

In addition, FDA has reports of unexpected side effects in people who’ve undergone the lipodissolve procedure.  These side effects include:

• permanent scarring
• skin deformation

deep, painful knots under the skin in areas where the lipodissolve treatments were injected

I continue to tell patients that I do not advise the use of these lipodissolve procedures.   For me (and the FDA), lipodissolve is “too good to be true.”

Suture Allergy vs Suture Reactivity

Updated 3/2017-- photos and all links (except to my own posts) removed as many no longer active. and it was easier than checking each one. 

This past week I was once again asked about suture allergy.  It has prompted me to revisit the issue which I have posted about twice now. (photo credit).

Sutures by the vary nature of being foreign material will cause a reaction in the tissue.  This tissue reactivity is NOT necessarily a suture allergy.

Many factors may contribute to suture reactivity.

• The length of time the sutures remain.  The longer the sutures are in, the more reactivity occurs.
• The size of the sutures used.  The larger the caliber of the suture, the more reactivity.  The increase of one suture size results in a 2- to 3-fold increase in tissue reactivity.
• The type of suture material used.  Synthetic or wire sutures are much less reactive than natural sutures (eg, silk, cotton, catgut).  Monofilament suture is less reactive than a braided suture.
• The region of the body the suture is used affects tissue reactivity.  The chest, back, extremities, and sebaceous areas of the face are more reactive.

In general, accepted time intervals for superficial suture removal vary by body site, 5-7 days for the face and the neck, 7-10 days for the scalp, 7-14 days for the trunk, and 14 days for the extremities and the buttocks.  The deeper placed sutures will never be removed.

Sutures meant to dissolve (ie vicryl sutures) placed too high in the dermis (which happens often when the dermis is thin) can “spit” several weeks to several months after surgery. This is a reactive process, NOT a suture allergy.  It usually presents as a noninflammatory papule (looks very much like a pimple) and progresses with extrusion of the suture through the skin. The suture material may be trimmed or removed if loose, and it is not needed for maintaining wound strength.  Rarely does this affect the scar outcome.

The remaining portion is a “repost” about suture allergies:

Allergic reactions to suture materials are rare and have been specifically associated with chromic gut. However, Johnson and Johnson mention known triclosan allergy as a contraindication for use of certain sutures (see below). Contact allergy to triclosan is uncommon.

Surgical gut suture (Plain and Chromic) is contraindicated in patients with known sensitivities or allergies to collagen or chromium, as gut is a collagen based material, and chromic gut is treated with chromic salt solutions.

MONOCRYL Plus Antibacterial suture should not be used in patients with known allergic reactions to Irgacare MP(triclosan).

PDS Plus Antibacterial suture should not be used in patients with known allergic reactions to Irgacare MP (triclosan).

VICRYL*suture should not be used in patients with known allergic reactions to Irgacare MP (triclosan).  [In rechecking facts, I found that only Vicryl Plus has the triclosan, so simple vicryl or coated vicryl should be okay.]

Surgical Stainless Steel Suture may elicit an allergic response in patients with known sensitivities to 316L stainless steel, or constituent metals such as chromium and nickel. Skin staples are surgical steel so should be used with the same precautions.

Dermabond -- Tissue glues should not be used in patients with a known hypersensitivity to cyanoacrylate or formaldehyde.

SO WHAT IS LEFT TO USE

So what is left to use in a patient who may have or has a proven allergy to suture or closure material?

Silk, Dexon, Nylon(monofilament or braided), Prolene, INSORB (absorbable staples), and any of the above listed (in the allergy section) to which the patient in question doesn't react negatively.

The choice of a particular suture material will have to based further on the wound, tissue characteristics, and anatomic location. Understanding the various characteristics of available suture materials will be even more important to make an educated selection.

The amount of suture placed in a wound, particularly with respect to the knot volume, affects inflammation. The suture size contributes more to knot volume than the number of throws. The volume of square knots is less than that of sliding knots, and knots of monofilament sutures are smaller than those of multifilament sutures.

REFERENCES

Allergic Suture Material Contact Dermatitis Induced by Ethylene Oxide: G. Dagregorio, G. Guillet; Allergy Net Article

Johnson and Johnson Product Information

Current Issues in the Prevention and Management of Surgical Site Infection - Part 2; MedScape Article

MECHANICS OF BIOMATERIALS: SUTURES AFTER THE SURGERY; Raúl De Persia, Alberto Guzmán, Lisandra Rivera and Jessika Vazquez

Materials for Wound Closure by Margaret Terhune, MD; eMedicine Article

Product Allergy Watch: Triclosan; MedScape Article by Lauren Campbell; Matthew J. Zirwas

New References

• Surgical Complications; eMedicine Article, May 29, 2009; Natalie L Semchyshyn, MD, Roberta D Sengelmann, MD
• Engler RJ, Weber CB, Turnicky R. Hypersensitivity to chromated catgut sutures: a case report and review of the literature. Ann Allergy. Apr 1986;56(4):317-20. [Medline].
• Fisher AA. Nylon allergy: nylon suture test. Cutis. Jan 1994;53(1):17-8. [Medline].

Related Posts

Allergies from Suture Material (September 7, 2007)

Suture Allergies Revisited  (April 30, 2008)

Suture (June 7, 2007)

Basic Suture Techniques (June 8, 2007)

Recent NPR Stories on Plastic Surgery

Updated 3/2017-- all links (except to my own posts) removed as many no longer active. and it was easier than checking each one. 

I want to say these two stories were well done (both aired on June 1, 2009).  I was actually interviewed, but not quoted, for the story on fat-grafting.  I pointed Allison Aubry to Dr Scott Spear as her expert.  He is involved in one of the U.S. studies on breast augmentation using fat grafting. 

Sculpting the Body with Recycled Fat by Allison Aubry.

Doctors Still Unsure Of Long-Term Risks

Surgeons like Dr. Scott Spear of Georgetown University Hospital want to know more about the techniques used to transfer fat for breast augmentation.

"We're at the beginning of the learning curve," he says. He has initiated a clinical trial to answer some questions about the best way to perform the procedure and whether there are any measurable risks. To date, there are no published studies in the United States, so doctors are relying on their own clinical experience.

Silicone Injections May Harm Some Patients by Patti Neighmond

When people get injected with silicone at pumping parties, Gorton says "there is no way to verify if they're using medical-grade silicone. You can go to hardware stores and buy a big tub of it," he says. "The element is the same, but it's just not the same safety or purity or quality."

My past related posts:
How Not to Do Buttocks Enhancement
Short Cuts to Beauty?
Fat Injections for Breast Augmentation
Complications After Autologous Fat Injections to the Breast – an Article Review

BOTOX -- Black Box Warning

 Updated 3/2017-- photos and all links removed as many are no longer active and it's easier than checking each one.

The U.S. Food and Drug Administration recently announced that safety label changes including a boxed warning and a Risk Evaluation and Mitigation Strategy (REMS) will now be required for all botulinum toxin products.  The agency took the action because of two main reasons.  The first one is the potential for serious risks that may occur from the spread of the botulinum toxin beyond the injection site.  The second reason is associated with the lack of interchangeability among the three licensed botulinum toxin products.

When the botulinum toxin spreads beyond the area of injection, symptoms similar to botulism may occur.  These symptoms include unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.

This “spreading effect” has been reported in both children and adults.  It has been reported most often in children with cerebral palsy being treated with the products for muscle spasticity.  Treatment of muscle spasticity is an off-label use of the drug.  The “spreading effect” has been reported in patients being treated for both approved and unapproved uses.

Botulinum toxin products include:

• Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan
• Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences
• Dysport (abobotulinumtoxinA),  a new FDA-approved product marketed by Ipsen Biopharm Ltd.

All are approved by the FDA for the treatment of  cervical dystonia.  Botox Cosmetic and Dysport are approved by the FDA for treatment of glabellar frown lines.  Botox is approved for the treatment of severe underarm sweating (primary axillary hyperhidrosis), crossed eyes (strabismus), and abnormal tics and twitches of the eyelids (blepharospasm).    All other uses are considered off-label.

The FDA has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when these products are used in accordance with the approved label.

It is important for those of us who use botulinum toxins to remember that the dosage strength between the products is not the same.  One unit of Botox is not equal in strength (potency) as one unit of Myobloc or Dysport. 

BOTOX® Cosmetic Insert (pdf)

Dilution Technique:  Using a 21-gauge needle and an appropriately sized syringe draw up a total of 2.5 mL/100 Unit vial or 1.25 mL/50 Unit vial of 0.9% sterile saline without a preservative…….
Injection Technique: Glabellar 

Using a 30-gauge needle, inject a dose of 0.1 mL into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units. Typically the initial doses of  reconstituted BOTOX® Cosmetic induce chemical denervation of the injected muscles one to two days after injection, increasing in intensity during the first week.

MYOBLOC® Insert (pdf)

The recommended initial dose of MYOBLOC® for patients with a prior history of tolerating botulinum toxin injections is 2500 to 5000 U divided among affected muscles. Patients without a prior history of tolerating botulinum toxin injections should receive a lower initial dose.  The duration of effect in patients responding to MYOBLOC® treatment has been observed in studies to be between 12 and 16 weeks at doses of 5000 U or 10,000 U.

Dysport®  Insert 

The units of Dysport are specific to the preparation and are not interchangeable with other preparations of botulinum toxin.

Glabellar lines Dosage

The dosage is dependant on the severity of the lines and the specific muscle being treated.

For the corrugator and procerus muscles 40 to 60 units divided between injection sites as follows:

8 to 12 units in each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 60 units

Improvement of severity of glabellar lines generally occurs within 72 hours after treatment and persists for 3 to 6 months.

It is important for us to educate patients and their caregivers of the potential adverse effects.  Some of these effects have been reported as early as several hours and as late as several weeks after treatment.  Patients should seek immediate medical attention if they develop any of these symptoms  --  unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.

Adverse events may be reported by health care professionals and/or consumers to the FDA's MedWatch Adverse Event Reporting program   by four ways:

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 800-FDA-0178 (the same form you would mail)
• Phone: 800-FDA-1088

REFERENCES

FDA News (April 30, 2009)

BOTOX® Injections; eMedicine Article, Sept 25, 2008; Robert A Hauser, MD, MBA, Mervat Wahba, MD, Theresa McClain, MSN, ARNP