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Type of Implant:   

(Also see breast implants in the FDA web site at http://www.fda.gov)

Almost always the patient will accept the doctor's recommendation for the type of implant. There were seven implant manufacturers before 1992 and the FDA. Now there are only four - McGhan, Mentor, PIP and Hutchinson. And their names, addresses and phone numbers are listed in their web sites. The choice of implants for the surgeon is discussed in chapter twelve of our handbook on breast implant surgery.

At times these companies will have videotapes on how to do the surgery. Wells Johnson supplies endoscopic equipment for the umbilical approach and has videotapes of that approach.

What the patient wants is the best possible result, with no future problems. Many of the reasons for choosing a saline over a gel, or a combination, or the meme is because of the rationale each one has for reducing the chance of or preventing the capsule contracture problem. The meme was the best. But since it was covered with polyurethane foam, it was removed from the market and will probably never return. It was this interface of texturing that led to the textured silicone implants.

Historically, in the beginning, after it was discovered that silicone injections could lead to unacceptable complications and silicone was first placed in a silicone bag, the first implants in the early 1960s were silicone gel. They were firm and teardrop shaped. The capsule contracture rate was greater than 90%, with most being as hard as your elbow, except for whatever breast tissue was overlying them. So, softer implants were developed in the late 1960s.

These softer implants would assume a teardrop position in the upright position, and so the teardrop shape was no longer necessary. Dacron patches were popular at that time to hold the implants up, and while they did this to a certain extent, the capsule contracture rate again approached 100% because of tissue reactions to the Dacron. As well, the breast tissue continued to sag over the implants, even when the implants stayed firmly fixed to the chest wall; this resulted in distortion. Dacron patches are very rarely used now.

In the early 1970s, saline filled implants were introduced and were softer than a gel implant in the same patient when independent observers compared one side to the other. The problem with the saline implants is the leakage and deflation rate (which seems to be about 50% over a period of 10 years in my experience with about 100 pure saline and around 500 combination gel and saline implant surgeries). Yet many of the pure saline and many of the combination implants that I used 20 to 25 years ago are still intact.

Implant deflation necessitates an additional operation, and since there is no doubt that some capsule contraction occurs with saline implants, why do we have the additional problem of deflation? For example, I removed some saline implants that had been put in previously and had already required one revision because of deflation; one side was completely collapsed and the other had a capsule. The implants were small, and the patient could have tolerated the firm side but was chagrined to have the asymmetry of a complete collapse of the other, so we replaced them both with silicone gel implants. The gels formed more and harder capsules, but were more popular than saline implants because of the reduced deflation problem, not because the result was more natural or softer. The saline implants were, in fact, softer than the gels.

When considering gel bleed as a cause of capsule contraction, please note that many patients have a capsule develop only on one side, and usually the capsule firmness and thickness is unequal on the two sides. Not only are a few capsules unilateral, but most patients have unequal firmness, and often it is markedly unequal with a soft breast on one side and spherical contracture and deformity on the other. These well-known findings must be considered for any theory of capsule contracture. Gel bleed would occur almost equally and could not cause such asymmetry in capsule formation.

The choices as of the year 2000 are all saline - textured or smooth, and to be filled with a valve or pre-filled.

We see and have seen rippling from textured silicone as well as saline implants. But the saline implants ripple to a greater extent and are more palpable, i.e. they can be felt and detected by feel more easily. 

Textured implants have thicker walls and can ripple more. The McGhan textured is deeper and the implant will not move or flow in the pocket. This appears sometimes slightly less natural. But this deeply textured implant is less likely to have distortion and capsule contracture, we believe, but one study from Sweden shows this not to be true.

The McGhan 468, or anatomical implant, is textured but still can ripple. It feels more firm and is more palpable below the nipple, where the tissues are thin. The 468 is a shaped, overfilled, fairly firm implant, but it does not allow much of a “stuck-on” appearance. Because it is overfilled and less mobile, it does not seem quite as natural as the softer, smooth salines. But in selected patients, it can be the best implant made. 

The smooth implants have less rippling than many of the textured, and are less palpable and less firm than the McGhan 468. But they could be subject to more capsule contracture.

As noted by the FDA, August 1991 BG pp. 2, "Since the saline filled implants do not have the silicone gel, they are probably even less likely to increase the risk of autoimmune diseases or cancer. But since both types of implants have the silicone rubber envelope, such effects cannot be totally ruled out, even for the saline filled implants." For an FDA update and a lot of information on implants, see breast implants at the FDA web site: http://www.fda.gov

So the FDA presumption or suspicion was that the silicone gel is more likely to cause autoimmune disease or cancer than solid silicone. Yet these reactions on the immune level are microscopic, and the difference in the gel and the solid silicone chemically on the level of the molecular structure is analogous to the difference in ice and water. And if the chemistry is the same, the molecular reaction is approximately the same.

Saline implants are the only type approved by FDA as of the year 2001, and at the FDA web site (http://www.fda.gov) there is a thorough discussion of the reasons for this. There is a history of implants and a presentation of McGhan and Mentor, the only manufacturers now approved for implants. 

Other factors for the choice of implants will be discussed further elsewhere.  Even if gel were to return, many probably would continue to use saline because they are good implants, they may cause less capsule contracture, they require smaller incisions, and they have an overall reputation of greater safety from all the unproven but suspected problems associated with gel.

 

Thursday March 2 6:54 PM ET

FDA Panel Deems 2 of 3 Breast Implant Brands Safe

By Lisa Richwine

GAITHERSBURG (Reuters) - The two most popular brands of saline-filled breast implants are safe and effective and should stay on the U.S. market, a federal advisory panel said Thursday after reviewing new data on possible complications.

The committee said, however, that the company that makes a third brand of saline implants did not present enough information to prove the benefits of its product outweighed its risks.

Saline implants first hit the market more than 25 years ago when the FDA had no authority to determine whether they were safe. The agency is scrutinizing them now because of concerns about complications such as infections and rupturing.

The FDA usually follows its panels' advice and is expected to decide whether to officially approve the implants later this year.

Breast implants are more popular than ever. About 150,000 women received them last year. Most are filled with saline, or salt water. Silicone-gel implants were banned for most women in 1992 over safety concerns.

The panel recommended the FDA approve implants made by Inamed Inc.'s (NasdaqNM:IMDC - news) McGhan Medical unit and Mentor Corp. (NasdaqNM:MNTR - news), two California companies that lead the breast implant market.

“The data shows these implants are reasonably safe and effective,” said panel member Dr. Phyllis Chang of The University of Iowa College of Medicine after studying McGhan's results.

But panelists said they were not reassured by data from Poly Implant Prostheses (PIP). They said the U.S. study the company presented did not include enough patients that were followed for an adequate time to truly evaluate the device risks.

Panel member Boyd Burkhardt, a plastic surgeon from Arizona, said he wanted to support PIP's implants because he thought their design would “dramatically'' reduce the rate of infections. But he found the company's data incomplete and found it difficult to understand that the company was “as ill prepared as you appear to be.''

PIP President Rick Hawk responded by saying the study results showed there was, “reasonable assurance of PIP's implant safety and effectiveness.”

Earlier, McGhan said a one-year study of more than 2,500 women showed the most common problem was contraction of scar tissue around the implants, which can cause changes in breast appearance and deflation. That occurred in 7.2 percent of women who had breast augmentation and in 12.5 percent of women who had breast reconstruction.

Leakage or deflation happened to 3.6 percent of women who had augmentation and 2.6 percent of reconstruction patients.

An FDA official who analyzed the company's studies said the risk of complications increased over time. Dr. Sahar Dawisha said 95 percent of reconstruction patients had reported some type of complication after five years.

Studies on serious ailments such as connective tissue or autoimmune diseases were not designed well enough to draw any conclusions about whether they were related to the implants, Dawisha said.

 

Scientific American September 1999

SILICONE SAFE

A major report finds that silicone breast
implants don't lead to cancer

 

Women who have silicone breast implants are no more likely than the rest of the population to develop cancer, immunological diseases or neurological disorders, a committee of the Institute of Medicine (IOM) reported on June 21. Moreover, mothers with implants may safely breast-feed their infants, as there is no evidence of toxicity in the milk. The IOM committee drew its conclusions after holding public hearings (during which women with implants told of their experiences) and reviewing scientific literature on silicone breast implants (first made in 1962) and silicone.

The analysis--funded by the U.S. Department of Health and Human Services and the National Institute of Arthritis and Musculoskeletal and Skin Diseases--is the latest in a series to have found such results. Similar announcements were made last year by scientists who were appointed by judges overseeing implant liability litigation in the U.S. and by researchers in Britain reviewing implant safety for the British Department of Health.

Still, the IOM committee points out, breast implants are not without risks. The tissue around the implants may contract, causing pain and disfigurement and leading to infection by skin bacteria that normally reside in the lactiferous ducts of a healthy breast. Also, implants have a finite life span, and rupture rates of gel implants and the deflation frequencies of current saline models have not been determined. Problems lead to additional surgery to replace or remove them.

Not everyone is convinced by the IOM report. Some believe that a study based on other studies--called a meta-analysis--is inherently flawed because of assumptions made about the quality of previous research. In any case, implant manufacturers have already agreed to a total settlement estimated at $4 billion with plaintiffs who claimed physical harm; now-bankrupt Dow Corning will be paying the most, some $3.2 billion.


--Christina Reed

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  1984-2014 American Society of Cosmetic Breast Surgery  Last modified: March 28, 2014