Dienstag, 24. Oktober 2017

Capsular Contracture & BIA-ALCL - Avoiding the ugly shadows of breast implants

In 1962 the first breast implants made of silicone were used in the USA for cosmetic and curative reasons (to replace the breast after cancer operations). From the outset, these operations were associated with the risk of developing a capsular fibrosis (contracture) [CC]. Depending on the degree of severity, a CC forces a new operation and thus the risks increase for cosmetic or surgical failure and for a lasting dissatisfaction of the patient. The subsequent costs can then be a multiple of the first operation.
But: the ugly shadows of breast implants can be avoided.

In 2013 biofilms were agreed upon as the cause of the Capsular Contracture (CC)How often are CCs?
Other possible causes of CC - and their avoidance
The biological meaning of CC
BIA-ALCL Breast Implant Associated - Anaplastic Large Cell Lymphoma
The time bomb requires a sustainable remediation of the patient
The necessary measures cost a lot of money
No implant replacement during the same operation
No surgery of the breast gland tissue during an implant insert
For the time being, no implants with a rough, textured surface
The avoidance and causal treatment of the capsular contracture without the use of antibiotics
Antimicrobial Peptides
No Antibiotics, no Infections with a well proven and cheap surgeon´s tool
A "guarantee promise" is possible and is already given
Recommendation to the patient

In 2013 biofilms were agreed upon as the cause of the CC

Not only breast implants but also other implants, such as artificial hip joints, pacemakers, blood vessel prostheses, and stabilizing nets (for example, hernia operations) may be affected by a contracting fibrous capsule. The common cause is the development of a biofilm around the foreign body, before the natural covering - consisting of only a few cell layers - has formed. The biofilm is a strategic survival form of bacteria, in which the germs organize in such a way that at least the internal living organisms last attacks from the outside, e.g. through our immune system or antibiotics. This biofilm invites our defense system unceasingly. T cells (cells of the lymphatic part of our immune
system) and myofibroblasts (scarring cells, which can contract) primarily try to fight bacteria and, on the other hand, isolate our bodies from the pathogenic germs by a self-decreasing encapsulation.
The coarse capsule, which is formed instead of a natural, tender coating, contracts with time, sometimes over the course of several years, and the inherent implant becomes as hard as a bulging balloon in its leather covering. At the latest, the patient insists on pain and ugly deformation of the breast on the liberating operation. The development of CC is not attributed to a mistake by the surgeon, but is regarded as fatal. The consequences and the costs for further surgeries must be carried by the patient as a rule.

How often are CCs?

According to the data in the scientific literature, CC occurs in up to 35% of all cases, but usually between two and ten percent. The problem sometimes arises three months, sometimes ten years after surgery. However, most cases have occurred within the first three years. There are clinics that foresee their patients the CC as a predicted. When a CC reaches stage BAKER IV, surgery must be performed. The patient decides on the operating time.

Other possible causes of CC - and their avoidance

Factors for the development of CC:
In addition to the biofilm [1]
the postoperative blood volume in the wound bed [2]
and the traumatization (tissue injury) during surgery [3]
To [1]:
If a system is used that promotes our wound healing and supports and supplements our organism with defending agents against bacteria, viruses and fungi, a special antibacterial and regenerative active environment can be achieved during and after the operation without the use of antibiotics, thus avoiding or destroying biofilms.
The nipples harbor bacteria in the milk channels. They are sealed with our defensive gel / film system before the operation. No germs can migrate into the operating area. For the same reason, no silicone implant may be used in surgical procedures that involve a surgical manipulation of the mammary gland (New Guideline of FDA).
To [2]:
With tested special kind of local anesthesia, the so-called tumescent local anesthesia, it hardly bleeds. The operation takes place almost "in the water". By gentle operation, meticulous coagulation and insertion of a drainage is tried to reduce the blood quantity to a minimum. The chemical amides in the anesthetic solution also inhibit bacteria.
To 3]:
If the operation is performed in local anesthesia, it must be carried out in a highly sensitive and gentle manner. With these measures the risk of developing a CC can be reduced to nearly zero percent.


The biological meaning of CC

4.8 million of bacteria were detected in only 1 milligram of tissue of a CC. In 2 grams of the fibrous capsule tissue, 2 billion more bacteria live as humans on our planet. It is a highly infectious material. The astounding amount of bacteria in the tissue of the fibrotic capsules was published in June 2016 in a study investigating 26 patients with CC and discovered BIA-ALCL-anaplastic large-cell lymphoma associated with breast implants-a malignant tumor of the T-cell lymph system.
The formation of the CC is the natural and successful attempt to keep the mass of the bacteria from the body by limiting and concentrating the place of the occurrence, reducing it as a problem zone and isolating it. The image of the sarcophagus around the damaged reactor in Chernobyl is suggesting itself. 

BIA-ALCL Breast Implant Associated - Anaplastic Large Cell Lymphoma

This - fortunately still - very rare malignant T-lymphocyte tumor is connected to certain gram-negative bacteria, the so-called Ralstonia spp. in the biofilms around the implant and occurs when capsular contracture (CC) is present.
It is a T-cell lymphoma. If the immune system - in this case the T cells - is stimulated over an extended period, rare mutations can occur, with the formation of a malignant T-cell tumor. A similar phenomenon has been known for over 30 years in a malignant B-cell lymphoma in the stomach. Here, Helicobacter bacteria are the triggers. In the meantime, more than 30% of all cancers are believed to be caused by bacteria.
Almost all cases of ALCL are recorded with implants with a rough, textured surface.
In an in-depth coverage in the New York Times of May 14, 2017:
359 patients with BIA-ALCL* are mentioned. The newspaper refers to data from March 2017 from the FDA (Food and Drug Administration), a globally respected US supervisory authority. Although there are unfortunately already deaths, the tumor is recognizable early and can then be treated well. The problem is the low level of knowledge among physicians who perform breast enlargement. Even in the US, where ALCL is being more discussed, only 30% of the plastic surgeons discuss this topic with their patients who ask for breast enlargement. In Germany there will be much less. The tumor leads untreated to premature death. Whoever does not produce (or hardly) CC has very little prospect of ever seeing this malignant cancer in his patients. It is noteworthy that our special intraoperative measures, which support the immune defense system of the antimicrobial peptides, keep away Ralstonia spp. (and all other bacteria) from contacting the implant and destroys them during operative breast enlargement.
* [Dr. Meinking: Meanwhile over 500 BIA ALCLs have been detected worldwide. Every year, more affected patients are recognized than the year before. As of May 1, 2018]

The time bomb requires a sustainable remediation of the patient

The new knowledge and the existence of a problem solution force to a new strategy in the treatment of patients with CC, with or without BIA-ALCL. They need to be recovered sustainably before the corrective cosmetic-surgical operation can be tackled with a new breast enlargement.
Therefore, if patients are asking for help because of a CC, they should be given the following clear recommendations:
1. Removal of the implants and complete removal of the fibrous capsule tissue on both sides.
2. Rinsing for at least 18 hours with a biomimetic defensin, which, in addition to its own antimicrobial effect, additionally supports nature and promotes, supplements and replaces body-borne bacterial defensive systems and triggers regenerative processes for improved wound healing. This is the core of our problem solving method in the case of capsular fibrosis (CC).
3. During the operation, probes of bacteriological and fluid samples from the interior of the capsule are taken for the bacteriological and cytological examination (immuno-marker CD 30)
4. Sending both capsules for histological examination
5. Submitting a part of the capsules, disintegrated in the clean room laboratory, for bacteriological examination
6. Collection of blood samples for the determination of inflammatory factors, inter alia. highly sensitive CRP
7. Wait at least 3 months, better 6 months and check the inflammatory markers
8. Decision-making on new, breast-enhancing measures. These can either be own-fat transfer (best method after CC) or the insertion of implants under an antibiotic-free, the biological defense imitating regime. Both methods, ie silicone implants or the own-fat transfer can be carried out in local anesthesia, without general anesthesia.
This procedure lead to eradication of the germs and drastic reduction of ALCL tumor cells, if existent, from the implant pocket and the fibrosis tissue. The verification of the CC is performed, and hopefully no tumor is detected. In the case of detected tumor cells, the specific cytostatic or irradiation therapy must be carried out. The treatment of BIA-ALCL has a good prognosis. The microbiome (the grouping of the bacteria in the tissue of the CC itself) is also recorded. In addition, the inflammatory status is established. It can be assessed in course of the process as follow-up.
Thus, the optimal time for the final cosmetic surgery can be agreed upon. Everything serves the patient's safety and their final satisfaction. Antibiotics can be dispensed with during even these surgical procedures.

The necessary measures cost a lot of money

The costs for the entire procedure - recovery of the implant bag of CC and bacteria plus renewed breast enlargement - including two operations with inpatient care, all examinations in different laboratories and the pathological institute, new implants and their insertion, are in the five-digit range. They are perhaps only partly taken over by the health insurance companies.
In the case of a desired breast enlargement with prepared own adipose tissue must be calculated individually.

No implant replacement during the same operation

Patients are not advised to undergo a direct implant replacement (in the same surgical session), even if the new implants are to be placed in a different site.
Likewise, an implant removal combined with a direct own-fat transfer is discouraged from, even if it is apparently successfully offered. First, germ-freeness must be established. It is known that biofilms and the following tissue growths can develop during internal bacterial loading also at inner wound interfaces - they occur in the case of self-fat transfer or in the case of the implant insert. The up-to-10-fold repetition of a CC in surgery, where implants are changed during the same operative session, is scientifically proven.

No surgery of the breast gland tissue during an implant insert

Corresponding to the statements made in the previous section, the simultaneous reduction/silicon-implant technique, which is still frequently performed, with enlargement of the breasts by implants during a single operation (reduction-mastopexy with implant insert), is to be dispensed with. This procedure to be divided into two operative steps, since bacteria from the glandular tissue (milk channels) can colonize the implant and form a biofilm.
According to more recent findings, better one uses an own-fat tissue transfer for the later enlargement.
The operative access through the areola should be avoided for the same reasons in the future, also. These indications come from an international group of recognized breast surgeons and are available in the new guidelines of the FDA.

For the time being, no implants with a rough, textured surface

The malignant tumor ALCL has almost occurred only with implants with a rough, textured surface.
As a result, drop-shaped, so-called "anatomical" implants are inevitably omitted. Smooth-walled, drop-shaped implants could "turn" after the operation and the "squinting" of the nipples would occur. The new findings therefore force the use of smooth, round implants. For the most part, they are always used in the USA. In Germany, they are still significantly below five percent of all implants used. The number increases slowly. In the Medical Well Clinic Dresden, round and smooth implants are inserted.

The avoidance and causal treatment of the capsular contracture without the use of antibiotics

We have accumulated experience with an effective, non-toxic, biomimetic defensive system for over 20 years. A congenital defense mechanism against bacteria, viruses, fungi and protozoa is used and strengthened (see below: antimicrobial peptides). In more than 9,000 operations in a series, we have seen no immediate infection of the operating area. No biofilm and no CC is produced. With this knowledge, also the strategy for recovery from all pathogenetic causes and effects, that lead to capsular contracture is plausible as well as promising. A solution to the problem can be offered with the sustained remediation of the patient without the use of antibiotics.
The rehabilitation concept involves two operations. No antibiotics are used in implant and capsule removal as well as in optional corrective surgery. They are not required in addition to the biomimetic defensin. The pressure for developing bacterial resistance to antibiotics is thus avoided. The bacterial flora of the patient (his individual micobioma) remains unaffected, the wound healing is not disturbed by the cytotoxic and general side-effects of antibiotics.

Antimicrobial Peptides

Probably since the end of the nineteenth century, and at the latest since 1922, when Alexander Fleming, six years before his discovery of the penicillin, fell a drop of snotty nose into the bacterial culture, and a few hours later he noticed an inhibiting court around the culture, Antimicrobial Peptides [AMP] were detected and known. He called the substance LYSOZYM. Of the more than 1,500 discovered antimicrobial peptides from the entire plant and animal kingdom (probably trillions thereof), more than thousand work well according to a certain principle: hydrophobic and cationic surface structures take the strongly negatively charged bacterial membrane into their chemical forceps and crack it (polycationic peptides). The biomimetic defensin we make use of, imitates these thousand. The death of the bacteria is fast, no time for developing resistance or taking steps against. Other cells, particularly mammalian cells, do not provide the AMPs with this attack surface. They do not harm man, they protect him.
The existence of antimicrobial peptides goes back to the beginnings of life more than 3 billion years ago. Like basic chemical and physical principles, they are part of the basis for the development of further life forms. Our highly developed immune system, which reacts much slower, has developed in interaction with the AMP mechanism. AMPs are found everywhere where bacterial stresses occur physiologically or pathogenically and protect, for example, the oral cavity and the intestines from infectious self-destruction. Genetic disorders of this system lead to diseases such as eczema or Morbus Chron. AMPs are always present, are the first to present and send signals to the immune system. Such signals trigger anti-infective but also regenerative actions.

No Antibiotics, no Infections with a well proven and cheap surgeon´s tool

Anyone who uses this system as a surgeon can completely dispense with antibiotics and still does not see any operations-related infections. We look back on an active support of the AMPs in any extra-fascial surgery for 21 years. Since 2012, our clinic has no longer used antibiotics.
The catastrophic situation resulting from multi-resistant microorganisms puts the AMP as a source of hope for the development of new antimicrobials in research interests.

 We give the guarantee promise

The co-operation of the described antimicrobial measures means that we hardly see "own" CC; the only one in 2002. Therefore, in the Medical Well Clinic Dresden since July 2016, the promise has been made until further notice, if a histologically confirmed capsular contracture (BAKER stage IV) occurs within three years after a breast enlargement in our clinic with implants, necessary surgical procedures including anesthesia, new implants (if desired), all examinations by other institutes, hospital care and after-treatment. The promise corresponds to a counter value in a five-digit range.

Recommendation to the patient

Ask your surgeon how she/he intends to avoid capsular contracture. How does she/he behave, should a CC develop? If she/he thinks that a CC cannot be prevented, or only with intraoperative massive irrigation with a solution of several antibiotics, then you know - provided you have read so far - something more.

Dresden, in August 2017
Dr. med. Michael Meinking
Head of the Medical Well Clinic Dresden

Alternate title for this essay:A clinic, free of infection, without antibiotics - how is that possible?

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