Dr. Kolb on the controversy

[Guest guest]

The Silicone Breast Implant Controversy

by E. Kolb, M.D., F.A.C.S.

There

has been a great deal of controversy regarding the safety of silicone

breast implants. For the women who have implants, conflicting media

reports can be a source of considerable stress. As a plastic surgeon

performing breast surgery for over twenty years and a woman who has had

silicone gel breast implants from 1985 to 1997, I hope to help inform

women regarding this topic.

There

are still many unanswered questions regarding the safety of silicone

breast implants. Studies are ongoing, but results may not be available

for several years. Education may help relieve some of the anxieties

until results become available.

Silicone

implants are silicone shells filled with either saline (salt water) or

silicone gel, or a combination of the two. Some silicone gel implants

are coated with a polyurethane material and are called Natural-Y

implants.

Silicone

breast implant complications can be divided into two categories: local

chest wall complications and more generalized “systemic†problems.

Local complications include capsular contracture, or the tightening of

scar capsule around the implant, malposition and rupture and/or leakage

of the implant.

Capsular

contractures can cause local discomfort and upward displacement of the

implant. Capsular contractures are believed to be the result of a

low-grade infection around the implant. The low-grade infection causes

tightening of the normal scar around the implant and as the implant is

squeezed, it appears more firm. Capsular contractures are more common

when the implants are placed behind the breast tissue and in front of

the chest wall muscles. This is felt to be due to the contamination of

the implant from breast ducts, which normally contain some bacteria. If

the implants are placed behind the chest wall muscles and the surgeon

avoids cutting through the breast tissue, the incidence of capsular

contractures is reduced. Irrigation of the surgical area with

antibiotics has also been shown to reduce the risk of capsular

contracture.

Malposition

of the implant is usually due to capsular contracture. When the scar

tissue tightens, the implant tends to ride up on the chest wall.

Malposition can also be due to steroids placed in the pocket or saline

implant during surgery. Steroids can thin tissue, leading to a gradual

downward migration of the implant.

Rupture of the implant occurs when the silicone shell has a hole or

tear, which allows the migration of the contents outside the shell.

Saline is reabsorbed without difficulty but silicone gel is not as

easily disposed of by the body. In most cases, the scar capsule around

the implant contains the majority of the silicone gel. Leakage occurs

when silicone “bleeds†through the silicone shell. The idea that

microscopic silicone has spread throughout the body has been a source

of concern for many women with ruptured and/or leaking implants. For

women who have migration of larger amounts of silicone gel outside of

the scar capsule, the surgical removal of this material is more

difficult. Again, however, the body tends to isolate the offending

material with scar and other tissue designed to contain foreign

material within the body.

Fortunately,

the majority of ruptures of silicone gel implants occur inside and are

grossly contained by the scar capsule. Surgical removal of the scar

capsule and ruptured implant is much easier if the silicone has not

migrated into tissues outside of the scar capsule. It is important

that the explanting surgeon use a technique that minimizes the risk of free

silicone coming into contact with tissues and that all of the scar

capsule be removed, as it contains silicone particles in the majority

of cases.

Pathological

examination of the scar capsules surrounding the silicone gel implants

often show macrophages filled with vaculated or foamy material. The

macrophages are the body’s scavenger cells, which attempt to ingest any

material that the body regards as foreign. Most silicone gel implants,

especially those manufactured prior to 1985, were known to have small

amounts of silicone gel “bleed†or leakage through this silicone shell.

The breast implant manufacturers were aware of these phenomena and, in

the early 1980’s, Dow Corning developed a “low bleed†gel implant,

which had a different silicone shell that was less likely to have

silicone gel bleed. We assume that the silicone gel bleed occurs to

some extent in all silicone gel implants and this accounts for the

foamy material found in the macrophages in the scar capsule. Even in

patients with unruptured implants, we assume that some silicone gel

travels beyond the shell of the implant.

The

early silicone gel implants developed by Cronin had fairly thick

silicone shells. These had a tendency to form capsular contractures

and often had calcium deposits within the scar capsules. The tendency

for implants to rupture increased when companies developed a thinner,

more pliable silicone shell. The thinner shell, developed in 1969, was

widely used until the development of the low bleed implant in 1984.

Further improvements in the silicone shell occurred in 1990, when a

textured silicone shell was developed which was not only more resilient

but was felt to reduce the incidence of capsular contracture.

Currently,

plastic surgeons are able to choose between two types of saline

implants. The smooth wall saline filled implants are felt to have

fewer problems with wrinkling, and the textured saline filled implants

are felt to have a lower incidence of capsular contracture. Because

the saline implants are a different (lighter) density than silicone gel

implants, they tend to feel “sloshy†or less natural than silicone gel

implants, especially if the woman has very little breast tissue to

cover the implants. For this reason, we usually recommend that saline

implants be placed beneath the chest wall muscles, as the muscle allows

for additional coverage over the implant, so that wrinkles and

irregularities are less noticeable. Placement under the muscle also

reduces the risk of capsular contracture. For women who already have

systemic symptoms, we recommend the use of smooth saline implants, as

textured implants are felt to have more risk of having silicone

material separate from the implant. It is important that symptomatic

women realize that the Silastic envelope of the saline implant is a

silicone polymer that may breakdown in the body into silica, thus

possibly also eliciting an immune response.

In 1984, silicone gel implants coated with polyurethane were developed.

This implant was called “Natural-Y†and was felt to produce a more

natural feeling breast due to tissue ingrowth into the polyurethane

material. There was a more pronounced foreign body reaction in the scar

tissue around this implant and a higher incidence of problems with

infection than with standard silicone gel implants. This implant was

useful in that some patients who developed capsular contractures around

regular silicone gel implants would not form contractures around this

implant. The problem that has never been resolved is the potential of

biological activity of some of the breakdown products of polyurethane.

Some patients also experienced localized allergic reactions of the

material. Polyurethane coated implants tend to be more difficult to

remove, as the tissue ingrowth is more advanced. We always attempt to

remove the entire scar capsule around this implant, as the polyurethane

foam is incorporated into the scar tissue. Natural-Y implants are no

longer available for implantation.

The

majority of the controversy regarding silicone gel implants centers

around the relationship of these implants to systemic or more

generalized disease. Having seen over 1,000 patients in the last ten

years with systemic symptoms and silicone breast implants, I have been

impressed with the similarity of the symptoms of these patients to

other patients I have treated with chronic infections, such as systemic

Candidiasis or yeast infections. There seems to be a spectrum of

severity, ranging from the patient who had mild chronic fatigue,

occasional joint and muscle aches, and normal lab tests (i.e., ESR and

ANA), to a more debilitating illness, such as fibromyalgia with

abnormal ESR’s. The more severely ill patients have frank

rheumatological-like illness, similar to SLE (Lupus), scleroderma, and

rheumatoid arthritis, with evidence of multi-system involvement.

The finding of frequently positive cultures of the scar capsules upon

explantation has lead some plastic surgeons to speculate that a low

grade chronic infection around a silicone gel implant may lead to a

chronic illness in which the immune system is unable to eradicate the

infection or dispose of the foreign body. The interesting question then

raised is whether this, in some individuals, can progress to

immunological disorders, similar to lupus or scleroderma. The presence

of silicone gel outside the implants, as occurs in rupture or silicone

gel bleed, may increase the potential for infection in the scar

capsule. If this is the mechanism of disease, then removal of the scar

capsule and implants as well as antibiotic irrigation of the pocket and

possible systemic antibiotics would seem reasonable. The placement of

another foreign body within the same area would not be advisable,

although it may be feasible to place a saline implant in another area,

such as behind the chest wall muscles. The role of chemicals besides

silicone as well as bio-toxins associated with the infections has yet

to be scientifically explained.

If, on the other hand, the silicone itself is somehow the main

offender, the advisability of replacing the implant with a silicone

shell, filled with saline, must be questioned. Can the body react to

the silicone shell or is only the silicone gel associated with an

immune system reaction? Silica has been reported in lymph nodes in

saline implant patients who have never had silicone gel implants.

Several studies to date have not shown an increased incidence of

traditional rheumatiological disorders in groups of patients with

silicone gel breast implants; however these studies do not appear to be

looking for the atypical symptoms commonly seen in silicone patients.

It appears that silicone is associated with more of a metabolic

disorder in conjunction with an immune hypersensitivity than a

traditional inflammatory autoimmune disease. Despite the lack of

evidence of widespread development of frank rheumatological disease in

large groups of breast implant patients, we are seeing symptoms of a

progressive chronic disease in patients with silicone gel implants that

appears to correlate with the amount of gel leakage. We are also

seeing improvement of symptoms after removal of the scar capsule and

implants. Patients often report return of their normal energy levels,

sometimes within several weeks following surgery. Some patients only

experience a partial improvement, but most patients treated to date

have not had a progression of their symptoms unless large amounts of

silicone gel still remain in the patient.

Currently, there is a heated debate as to the safety of silicone gel

implants. I believe that since we are seeing such a high ruptured rate

as silicone gel implants age, especially in the implants placed during

the 70’s and early 80’s, we need to address the question of whether

silicone gel implants should be removed based solely on the high

incidence of rupture and/or leakage. Unfortunately, no currently

available test, including mammography, breast ultrasound, or breast MRI

can always diagnose rupture of the silicone gel implant within the

capsule. There seem to be a high incidence of the onset of burning

pain along with upper extremity numbness associated with implant

rupture, even when these studies are negative.

I would advise any woman with silicone gel breast implants who

experiences a sudden change in shape and/or contour of her breast, or

develops burning pain or numbness and tingling in the arm, be evaluated

by a plastic surgeon for the possibility of implant rupture. If the

patient has generalized symptoms, such as chronic fatigue and muscle

and joint aches, especially if these symptoms are progressive, she

should consider removal of the scar capsule and implant, even if the

studies do not show a ruptured implant. If the symptoms are severe, I

would not advise replacement of the implants with saline implants, as I

have found recovery to be often delayed if the saline implants are

replaced at the time of implant removal. For many women, the prospect

of losing their breast fullness is not acceptable, so reimplantation

with saline implants at the time of implant and scar capsule removal

may be worth the risk of a more prolonged recovery.

In addition to removal of the scar capsule and implant, both local and

systemic treatments with antibiotics and anti-fungals help treat any

sub-clinical infection in the area of the breast implant. Systemic

fungal infections are treated if present, and we advocate therapies

that stimulate recovery of the immune system. We advise patients on the

use of Inositol and other supplements to aide the body in the

mobilization of silicate.

We

provide a holistic approach to women with breast implant problems,

including comprehensive patient education, a supportive and caring

environment, and therapies to stimulate the immune system. This,

together with the appropriate surgical treatment will hopefully provide

a conducive environment for healing to occur.

The

following statements and/or supplements have not been evaluated by the

FDA. The FDA suggests that you consult with a health care professional

before using any dietary supplement. This product is not intended to

diagnose, treat, cure or prevent any disease.

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