Capsular Contracture

 

What is capsular contracture , and what causes it?

Photos of capsule contracture 

When breast implants (or any foreign object, including, but not limited to: pacemakers,  artificial joints, etc.) are placed into the body, the body forms a lining around it. This lining, or capsule, is formed by your own living tissue. Many people refer to this lining as the "capsule", "tissue capsule", or "scar capsule", although it is not exactly the same as scar tissue.  This is the body's natural response.  It is normal, and to be expected.

Capsule contracture, the most common complication of breast augmentation surgery, can happen at any time, but seems to be more common in the first several months after surgery. At the time of the initial surgery, a pocket is made for the implant. During the healing process, a capsule forms, which is comprised of fibrous tissue. The body is genetically programmed to shrink scar tissue somewhat. Under normal conditions, the pocket remains open, thus allowing the implant to look and feel natural. However, in some people, the capsule will tighten, and squeeze the implant. This makes the breast implant feel hard, and distorts the appearance of the breast. In the later stages, the implant feels very firm, and may take on a "ball-like" look. It's important to remember that it's not the implant that has hardened. The shrinking of the capsule compresses the implant, and causes it to feel firm/hard, but once the implant is removed, it's just as soft as it was the day it was inserted. 

Currently, the causes for capsule contracture are still very unclear.  The following are thought to put you at higher risk:

• Transient germ contamination.  Germ contamination and/or long-term bacterial contamination of the implant shell can cause an inflammatory reaction, thus leading to the shrinking of the capsule. 

• Subglandular placement.  Breast implants placed above the muscle tend to have higher capsular contracture rates, versus breast implants placed in behind the muscle, also known as submuscular placement.

• Infection.  Capsule contracture seems to be more likely following an infection.

• Seroma.  If you have had seroma, you may be at more risk for capsular contracture.

• Hematoma.  Hematomas can cause an inflammatory reaction, which can lead to capsule contracture.

• Smoking.  Smoking decreases the oxygen levels in the blood, which could result in delayed healing, and possibly an inflammatory reaction.
  
  
   

  Read discussions about capsular contracture CC Revision Advice Alternative treatment for capsular contracture Accolate and Capsular Contracture Can capsular contracture "go away"? How does capsular contracture feel when it starts?

   

Baker Grading System - 4 Grades of Capsule Contracture

• Baker Grade I   - The breast is normally soft, and looks natural. (Basically, we all have this, since we all have a "capsule".)  It is only when the capsule starts shrinking/contracting that capsule contracture occurs.

• Baker Grade II  - The breast is a little firm, but appears natural.

• Baker Grade III - The breast is firm, and is beginning to appear distorted in shape. 

• Baker Grade IV - The breast is hard, and has become quite distorted in shape.  Pain/discomfort may be associated with this level of capsule contracture. 
  
   

Capsulectomy and Capsulotomy

Closed Capsulotomy

In this procedure, the surgeon forcibly squeezes the implant, in hopes of "popping" the scar tissue (opening it up). Breast implant manufacturers do not recommend this, as it can lead to possible rupture of the implant. Implants that are ruptured due to closed capsulotomy are not covered under the warranty (this includes Mentor and McGhan). You are awake for this, and receive no local anesthesia. And yes, it can be painful, but thankfully, it only lasts a few seconds, and then it's over. 

This procedure is usually not recommended, since it has a very low success rate, and again, puts you at risk for breast implant rupture.


Open Capsulotomy

In this procedure, the surgeon goes into the pocket and "scores", or cuts, the scar tissue, in order to release the capsule's hold on the implant. The scar tissue is not removed. Depending on the surgeon and his skill/experience, it's possible to do this procedure via the transaxillary incision, as well as via the crease and areola  incisions. You will be given a local anesthetic with IV sedation, or general anesthesia for this particular procedure.


Open Capsulectomy

T his is the most successful treatment for capsule contracture. In this procedure, the surgeon goes in and actually removes the scar capsule. This is a lengthier surgery, but is well worth it, especially when it's successful. Once the capsule is removed, your body will form a new capsule around the breast implant. 



Can capsule contracture be prevented? 

Unfortunately, there is no way to completely eradicate the chances of getting capsule contracture. However, there are things that you can try: 

• Choose the partial or complete submuscular placement instead of over the muscle placement, which has been proven to have a higher incidence of capsule contracture. Implants placed over the muscle come into contact with the breast ducts, which are known to harbor bacteria. Having the implants placed below the muscle helps to prevent this. The muscle also "massages" the implant. Some doctors believe that this is another factor that decreases capsule contracture. 

• Textured breast implants were invented in hopes of preventing, or at the very least, reducing the incidence of capsule contracture. However, there have been several studies that have shown that when the implants are placed under the muscle, there is really no difference in cc rates between smooth implants and textured implants, as well as studies that have shown otherwise. 

• Silicone gel breast implants, especially with a smooth shell, tend to have a higher incidence of capsular contracture than saline breast implants.

•  Post-op massaging of the implant. 

• Take vitamin E orally.  However, you do NOT want to take this, or anything else that interferes with your blood's clotting capability PRIOR to surgery.  Many surgeons recommend that their patients wait 2 weeks, or so, before taking vitamin E, aspirin, etc. 

• Wear a compression bra. (See photo here)

• Do compression exercises. One example is laying on the floor, on your stomach. This compresses the implant and "flattens" it out, thus helping to keep the pocket open. 

• As a precautionary measure, you should alk to your plastic surgeon regarding taking antibiotics prior to dental cleanings.  There isn't sufficient data on whether or not a general dental cleaning will put you at risk for capsule contracture.  This is still "up in the air".  However, for those who have had problems with capsular contracture in the past, it's worth taking a single dose of antibiotics, just to be on the safe side.
  
  If you are having gum surgery, or something more involved than a regular dental cleaning, you should, again, definitely talk with your surgeon regarding antibiotics. 
  
  Thankfully, most women do not have any problems when they DON'T take antibiotics. 

 

Can I take medications or nutritional supplements to treat or prevent capsular contracture?

Some surgeons believe that Papaverine (also known as Papacon, Para-Time S. R., Pavabid Plateau, Pavacot, and Pavagen) may help to stop the progression of capsule contracture. Pavabid is in a class of drugs called vasodilators. It relaxes veins and arteries, which makes them wider and allows blood to pass through them more easily. Papaverine is also a smooth muscle relaxer.  The target of Papaverine (when used to treat capsule contracture) is the smooth muscle-like fibers in contractile scars. The flip side is that some doctors do not believe that it helps at all. There is no evidence that this drug will stop and/or reverse the effects of capsule contracture. 

Scar tissue consists of collagen strands. Taking vitamin E is thought to soften these strands, thus making the capsule softer and more pliable.  Unfortunately, there is no evidence that vitamin E really works in treating or preventing capsular contracture.  However, it shouldn't hurt to try it. 

Talk with your doctor.

Some plastic surgeons use antibiotics to treat capsular contracture, though this isn't always successful.  In the event that a person has capsule contracture, and the breast begins to swell, and/or become sore or painful, antibiotics may help.  However, simply giving someone antibiotics in hopes of reversing a well-formed capsule doesn't seem to be successful.
 

New treatments for capsule contracture?

Accolate, a drug used in the treatment of Asthma, is the newest treatment for capsule contracture.  It is used due to it's anti-inflammatory properties. It is a leukotriene receptor inhibitor.  Leukotrienes are a group of chemical compounds that occur naturally in white blood cells (aka leukocytes).  They're able to produce allergic and inflammatory reactions.  This drug inhibits this process.  Accolate is said to work best on early contractures, but may reverse existing capsules.  If the capsule is well-formed, it can take several months to successfully treat it.  Prophylactic treatment may be used in women who are at a higher risk for capsule contracture, such as those who have had it previously. 

Clinical studies still need to be done regarding the use of Accolate as a form of treatment for capsule contracture, although it does seem to have helped many women. 

External ultrasound, according to some doctors, helps capsule contracture.  It may possibly reduce swelling, help to regulate inflammation, and facilitate healing, thus reducing the risk of recurrence.  Ultrasound is usually accepted by patients, as it is easy to perform, and free of any major complications.  Prophylactic ultrasound treatment may be used as well.

More studies are still needed on both external ultrasound, and Accolate, as forms of treatment for capsule contracture.  Use of Accolate for capsule contracture is "off-label" use.  The FDA has not approved Accolate for this type of use.

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Excerpt below is from an ASAPS news release - 2002

"In many cases, the patients and surgeon noted a very significant softening and improved appearance of the breast following treatment with Accolate for a period of one to three months", says Dr. Schlesinger.  "For some women who otherwise would have needed surgical correction of their contracture, surgery was no longer necessary."

Dr. Schlesinger says that he has been using Accolate "for approximately three years and has found it most affective in treating early-phase contracture (less than six months) and as a preventative treatment in patients considered "high risk" for contracture; this group includest hose with a history of previous capsular contracture and patients with a tendency toward hypertropic scarring.  However, he says there has also been some success in using the drug to treat established contracture.

"Our preliminary findings do not suggest that Accolate is the answer for every patient with contracture," advises Dr. Schlesinger.  "For some patients whose capsular contracture is severe and long-standing, meaning a year or more, surgical intervention is still the best option.  But for patients who are not good candidates for surgery or elect not to undergo surgery - such as breast reconstruction patients who may have experienced capsular contracture following radiation therapy - it may be possible to achieve some degree of improvement using Accolate."  Dr. Schlesinger's results are based on a treatment of 20 milligrams of Accolate administered twice daily - the same dosage indicated for the preventative and chronic treatment of asthma in adults and children 12 years of age or older.  From November 1996 through 1998, Accolate tablets were prescribed more than 4 million times for asthma treatment, and reportedly, the drug is well tolerated.  Side effects may include headache (12.9%) and nausea (3.1%).

"Dr. Schlesinger's clinical experience with Accolate is very preliminary, but is consistent with other research suggesting that certain medications may be useful in helping to prevent or improve the symptoms of capsular contracture in properly selected patients," says James Baker, Jr,. MD, Breast Surgery Committee chair for the American Society for Aesthetic Plastic Surgery.

Article by Dr. S. Larry Schlesinger, MD.

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The Effect of Zafirlukast (Accolate) on Early Capsular Contracture in the Primary Augmentation Patient: A Pilot Study

Russell R. Reid, M.D. PhD, Susan D. Greve, MS RN, and Laurie A. Casas, M.D. F.A.C.S.
Division of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL
and Evanston Northwestern Healthcare, Glenview, IL

Introduction:  Significant capsular contracture (Baker Class III or IV), occurring at a rate of 4.6-25% in submuscular saline breast augmentation¹, presents a formidable challenge to the plastic surgeon.  Certainly, the recent use of the leukotriene antagonist zafirlukast (Accolate; AstraZeneca, Wayne, PA) for contracture reversal has received much attention in the popular media.  However, validation of its effectiveness rests only on limited case series and anecdotal reports^2,3.  To this end, a single surgeon’s experience using Accolate in the treatment of capsular contracture in primary, submuscular augmentation with saline smooth –walled implants is presented.

Methods:  From the period of December 2001 to January 2003, the senior author performed 37 bilateral submuscular augmentation mammaplasties with saline smooth-walled breast implants (74 breasts).  All patients were placed on the same postoperative protocol, which included early implant mobility (massaging) and vitamin E 400 I.U. orally twice daily at 4 weeks.  A prospective analysis of the effects of Accolate on early capsular contracture was carried out in the following manner.   Patients were regularly evaluated in the office by the operating and clinical staff (2 independent observers) and rated for capsular contracture using a modification of the Baker classification⁴.  We define contracture as follows:  Class 1=breast absolutely natural, augmentation undetectable; Class 1.5=breast soft, but implant is detectable by physical examination; Class 2=mild firmness, prosthesis not detectable by examiner or patient; Class 2.5= mild firmness and implant detectable by examiner but not patient; Class 3=breast moderately firm and detectable by patient; Class 4=severe firmness, obvious from observation, with pain.  Patients who demonstrated any capsular contracture (>=1.5) were given Accolate 20mg orally twice daily and assessed at 3- and 6-month timepoints for any change in contracture.   The endpoint of this study was 6 months or a return to a Class 1 capsular score.   One patient failed to complete the study.  

Results:  Using our modification, 33 of the total 74  breasts had no capsular contracture and thus were rated Class 1 (45%).   41 breasts (55.0%) were found to have early, mild capsular contracture (Class 1.5 or greater).  Of these 41 breasts, 29 mildly contracted breasts have completed the protocol: 12 breasts were scored as 1.5, 15 breasts as 2, 1 breast as class 2.5 and 1 breast as class 3.  Responses were scored as either complete (return to class 1), partial (reduction in capsular contracture index by 0.5), or nil (modified Baker class the same or worse despite therapy).  Mean follow-up was 6.3 months. After an average of 4.8 months of treatment, 16 out of 29 breasts (55.2%) demonstrated a complete response to Accolate therapy, whereas 7 of 29 (24.1%) demonstrated a partial response to the leukotriene antagonist.  The remaining 6 of 29 (20.7%) had no response to therapy, either staying the same grade or worsening.  Therefore, a positive response (complete or partial) was seen in a statistically significant proportion of treated breasts (79.3%, p<0.05).

Conclusions:  Our initial results support the effectiveness of Accolate in early capsular contracture after submuscular saline smooth augmentation mammaplasty.  Further follow-up will demonstrate its long-term effects.

1)     Mentor Corporation.  Saline Prosthesis: 2002 Product Insert.

2)     Sclesinger SL, Ellenbogen R, Desvigne MN, Svehlak S, and Heck R.  Zafirlukast (Accolate): A new  treatment for capsular contracture.  Aesthetic Surg. J. 2002; 22: 329-336.

3)     Schlesinger SL and Heck RT.  A new treatment for capsular contracture. (Letter to the editor).  Aesthetic Surg. J. 2002; 21: 164-165.

4)     Spear SL and Baker Jr., JL.  Classification of capsular contracture after prosthetic breast reconstruction.  Plast. Reconstr. Surg. 1995; 96: 1119-1124.

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