What You Should be Aware of Regarding Breast Implants

As per a report released by the American Society of Plastic Surgeons, in 2008 over 300,000 women underwent breast enlargement surgery in the US, to get their breasts enhanced by implants, either silicone-gel or saline. In the same year, nearly 80,000 breast cancer patients had breast reconstruction following mastectomy, usually with implants. As per the American Society of Aesthetic Plastic Surgery, the popularity of surgical breast enhancement has increased 300% when compared to 1997, when there were about 101,000 of these kinds of procedures  .

At the same time, the American Society of Plastic Surgeons documented that over 40,000 breast implant removal operations were done in 2008. Presented with this data, one can easily understand that, despite the growing popularity of breast implant surgery, well-informed women and doctors continue to question the safety of surgical breast augmentation. 

A lot of women are understandably puzzled by the contradictory information they are getting. In an attempt to bring some clarity to this issue, we present the facts regarding what is actually known and what is unknown concerning the risks associated with breast implants.

Before we proceeding further into our discussion about breast implants, we must state that our general recommendation is that women who are seeking to enlarge their breasts should first try breast enlargement without surgery with natural, herbal breast enhancement products such as Breast Actives. Only in the unlikely event of this option failing to provide the desired results, should they even begin to consider breast augmentation surgery.

We are going to first provide a quick historical background on breast augmentation by implants in the USA, and then we will address the following queries:

• What are the recognized risks associated with breast implants?
• What occurs when breast implants rupture?
• Can breast implants cause sickness?
• What additional issues exist about breast implants?
• What happens if I have to have my implants taken out?
• Are there newer types of implants, other than silicone-gel and saline, that are safer?

Brief Historical Background of Breast Implants the United States

Breast implants of silicone envelopes filled with saline solution or with silicone-gel were initially introduced in the US in the nineteen sixties, but until the nineteen eighties sales were slow. However, by 1990 nearly 1,000,000 women had opted for breast augmentation by implants, regardless of the fact that no safety studies or reports had been released. The majority of these women had implants of silicone-gel, which were favored by the cosmetic surgeons at that time. 

These days, most products for medical usage have to be demonstrated to be effective and safe before these can be marketed in the United States. However, prior to 1976, that was not the case for medical devices designed for implanting. It was only in 1991 that the US FDA made it mandatory that organizations marketing silicone-gel breast implants demonstrate that these implants were safe to use - that is, after these products had been in use by women in the U.S. for almost thirty years. At this time, the media first began reporting instances of women experiencing problems with breast implants, and began quoting medical professionals who were worried about the safety of these implants. When the implant makers provided their reports to the FDA, the data on safety was found insufficient to justify FDA approval.

With regard to saline implants, it was only in the year 2000 that the US FDA called upon manufacturers to demonstrate that their breast implants filled with saline solution were risk-free. Then, despite high incidence of complications resulting from these implants, the FDA gave its approval, for the first time, for the sale of saline implants for breast enhancement.

Approval from the US FDA for breast implants filled with silicone gel came in November 2006 for the first time. From 1992 to 2006, the use of silicone-gel implants was limited to clinical studies which were mainly for breast reconstruction for patients after mastectomy due to cancer and for women with ruptured implants. Patients had to be advised that these implants did not have FDA approval and they were to be monitored regularly by their surgeons as part of the trials, to generate safety information for the benefit of all women who had silicone-gel implants. In November 2006, silicone-gel filled breast implants from two companies were finally approved by the FDA. However, even till now there are restrictions in their use. For instance, these implants are authorized only for women who are over age 22, because women younger than 22 years are considered to be still developing emotionally and physically and may not fully appreciate the risks involved .

What recognized risks are associated with breast implants? 

Reports of problems amongst women who have breast implants can be found in professional medical publications and have been discussed at FDA conferences. There are several short-term as well as long-term risk factors that every woman who is considering enlarging her breasts with implants should know about.

The term, "local complications", refers to issues which arise in the breast region which are obviously associated with the implants or the surgical procedure. Common problems include infection along with other risks associated with surgery, persistent breast soreness, lack of sensation in the breasts or nipples, capsular contracture, rupture and leakage of the implant fluid, necrosis (skin death), the requirement of further surgical treatment, as well as "cosmetic" or aesthetic issues (such as unhappiness with the appearance of the breasts with implants).

Analyses of silicone-gel and saline breast implants carried out by implant producers have demonstrated that in the initial three years, about 75% of breast reconstruction patients (following mastectomy due to cancer) and nearly 50% of breast augmentation patients suffered a minimum of one "local complication" - for example soreness, or infection, or hardening of the breast, or the requirement of further surgical procedures.

For instance, amongst breast reconstruction cases:

• 46% of patients who had breast implants containing silicone-gel and 21% who had implants containing saline solution had to undergo a minimum of one repeat surgery inside of 3 years;
• 25% of women with silicone implants and 8% of women with saline implants had their implants taken out;
• 6% of those with silicone implants and 16% of those with saline implants suffered soreness in their breasts.  

For breast enlargement cases, the rates of complications were lower, but nevertheless were still considerable. Local complications from implant surgery and re-operations are detailed, along with photos, in the FDA Implant Consumer Handbook.

The risks associated with breast augmentation surgery include dangers from anaesthesia, post-surgery infection and hematoma (blood collecting around the implant) which can vary from slight to serious from case to case. While surgical risks tend to be highest during and immediately following surgery, subsequent problems can require further surgical treatment later, that will again involve the same risks. Women who opt for breast implants may have to deal with these surgical hazards several times in their lifetimes, if they require re-operations to fix problems with implants or to replace damaged or ruptured implants.

Typical local complications involve decrease of sensitivity in the nipples or over-sensitive nipples which are painful. Quite often, women are unhappy with the actual aesthetic outcomes of breast implant surgery, because their boobs appear or feel artificial or unnatural or irregular in shape, or the liquid in saline implants makes a "sloshing sound". These kinds of issues can negatively impact sexual activity.

Scar tissue forming around any type of implant could become hard or tight around the actual implant. This particular problem, that occurs quite frequently, is known as capsular contracture. Although the scar tissue is within the body, it can still result in the breasts becoming extremely hard as well as out of shape, causing distress which can range from minor to seriously painful. A photo of capsular contracture may be seen in the FDA Handbook.

Scientists have demonstrated that bacteria or mould can develop within saline implants. They have expressed fears regarding the bacteria or mould migrating into the body, should the implant rupture. Exactly what the consequences of this might be for the woman with the implants, or for a breastfeeding child, have not yet been evaluated.

What occurs when breast implants rupture?

Breast implants will not last a woman's lifetime. All breast implants, whether silicone or saline,  will ultimately rupture during the average life span of a woman. However, we do not know precise number of years the breast implants, presently available, will last. Research into silicone-gel breast implants, currently being sold in the US, indicates that a majority of implants last between seven to twelve years. However, several break in the first few months or years after insertion, whilst some last beyond fifteen years.

In a research study by FDA researchers, the majority of females experienced a minimum of one ruptured implant inside of eleven years, and the chances of rupture increased with each passing year. Silicone moved out of the implant capsule in 21% of the women, although most were not aware of this.

Implant manufacturers were asked to research breakage and furnish their reports to the FDA. Short-term studies of present day saline implants indicate that 3 to 9% rupture within the 1st three years. One producer of silicone-gel implants reported to the FDA that their investigations revealed that 3 to 20% of their implants rupture within 3 years. A study in Denmark of silicone implant rupture found that a majority of implants last for around 10 years and that most will break between 11 to 20 years. The few that still remain intact at 20 years will almost certainly break thereafter.

Frequently, women who have silicone-gel implants are not aware that the implants are damaged or leaking. Cosmetic surgeon Dr. Scott Spear and Dr. Susan Wood, the former director of FDA's Office for Women's Health, explain that MRI or "magnetic resonance imaging" is the only sure method for detecting an implant rupture. Mammograms are not dependable for detecting a broken implant, and in cases where an implant is already ruptured, the mammogram's pressure might lead to the implant's silicone gel leaking out of the capsule.

Migration of Silicone: Scientific investigation has proven that normal body temperatures can melt down  silicone gel to silicone liquid. There have been reports of the movement of silicone following leakage, from the implants into lymph nodes and other internal organs. The question arises "what will happen if liquid silicone moves into the lungs, or into the liver, or into other internal organs"? A report released by the Royal Academy of Medicine in Scotland observed that a woman, who had a silicone-gel implant in her calf which ruptured, coughed up silicone exactly like the silicone in the ruptured implant. This has possibly severe ramifications for women with silicone-gel breast implants, given that breast implants are bigger than calf implants and are located much nearer to the lungs.  

So, questions remain unanswered about the possible dangers of silicone migration from implants to other parts of the body.

Can breast implants cause sickness?

A more debatable issue is whether or not breast implants can cause any type of diseases or ailments, in addition to complications in the breast region.

Auto-immune diseases. A number of reports have came to the conclusion that there exists no proof that implants cause any kind of systemic sickness. But, all these reports relied on investigations which focused upon connective-tissue or autoimmune diseases in women with implants that were in place for a relatively short period -- between a few months to a few years. Given that these types of ailments usually take many years to develop and be identified, research that includes only women with implants in place for short periods cannot be regarded as dependable in determining if breast implants do or do not increase the dangers of acquiring these illnesses in the long term.

Research carried out subsequent to these reports being publicized suggest that implants could be associated with auto-immune diseases. For instance, FDA researchers carried out a survey of women with silicone gel-breast implants in place for not less than 7 years and noted that women with implants that leaked were significantly more prone to developing fibromyalgia, a painful auto-immune disorder.  The fibromyalgia risk factor remained even after statistically adjusting for patient's age, age of implant, and implant maker. These investigators also observed that women, whose silicone-gel implants were leaking, were considerably more likely to develop a minimum of one of the following debilitating and painful ailments: polymyositis, Hashimoto's thyroiditis, dermatomyositis, mixed connective-tissue ailment, pulmonary fibrosis, polymyalgia and eosinophilic fasciitis.

Do patients with breast implants suffering from auto-immune symptoms improve if their implants are taken out? A report presented at the American College of Epidemiology in 1998 of a study of 95 women with silicone-gel breast implants who suffered from rheumatologic symptoms like joint pain, indicated that removal of the implants resulted in improvement of their conditions in 42 out of 43 women (97%). In contrast, of the 52 women whose implants were not taken out, the rheumatologic symptoms became worse in 50 case (96%). Additionally, a university researcher has documented that silicone induces an immune response, and cellular analyses show that these types of responses are related to atypical types of connective tissue ailments.

A survey of in Denmark of women with breast implants in place for 19 years on average observed that these women were more prone to experience exhaustion, Raynaud-like symptoms (white fingers and toes if subjected to cold), and loss of memory along with other cognitive symptoms, in comparison with women of similar age within the general populace. The differences were statistically significant.

In spite of finding that women with implants were two to three times more likely to experience those symptoms, the investigators, who were financed by a silicone implant producer, came to the conclusion that long-term usage of breast implants "does not seem to be associated with autoimmune symptoms or diseases". Nevertheless, the symptoms documented by them could very well be caused by autoimmune ailments.

Cancers. Research by scientists at National Cancer Institute (NCI) demonstrated 21% higher danger of cancer for women who had implants in place for seven years or more, in comparison with women of the same age within the general population. The increase was mainly in cancers of the brain, respiratory system, cervix, and vulva. But, much more investigation plus more studies are required before any firm conclusions can be drawn.

The US FDA has recently stated that there is a possible association between breast implants and the development of a rare type of cancer known as "anaplastic large cell lymphoma".

Death. Another NCI study observed that women with breast implants for 12 or more years were more likely to die from cancer of the lungs, brain tumors, other respiratory diseases, and suicide, in comparison to patients of other types of cosmetic surgery. Breast augmentation patients were not more prone to smoking than patients of other types of plastic surgery. Therefore the variation in respiratory system illnesses was not associated with using tobacco. However, more scientific studies are required to better adjust for variations in relevant lifestyle and health behaviour patterns. Three studies in Scandinavia have documented that Swedish, Finnish and Danish women who had implants for breast enlargement were 3 times more prone to commit suicide in comparison with women within the general population. However the connection between increased suicide rates and breast implants, if any, is not yet understood.

What additional issues exist about breast implants?

Breastfeeding. As per the Institute of Medicine (IOM), women who have undergone any type surgical procedure on their breasts, which includes surgery for breast implants, are, at a minimum, 3 times more likely to have an insufficient supply of milk for nursing a baby, than women with no history of breast surgical procedures. Worries regarding the possible risks to babies breastfed by women with breast implants have also been brought up, but not enough research has been carried out about this to reach any kind of firm conclusion on this question. A small study of females with breast implants of silicone-gel discovered that babies born and breastfed by a woman after she got breast implants inserted had increased levels of a toxic type of platinum in their blood when compared with babies born of the same mother before she got breast implants.

Detection of Breast Cancer. Breast cancer occurs amongst women more frequently than any other type of cancer. It is an established fact that early detection of breast cancers can save lives and that early detection is fairly easy with the help of mammograms. Therefore, whether or not breast implants can interfere with mammograms and their results is an issue of vital importance.  

There are, in fact, various ways whereby breast implants could actually result in delaying breast cancer detection:

• Even though mammography can be conducted by methods which reduce the interference from implants, studies have revealed that about 55% of breast cancers are likely to be undetected in women with breast implants.
• FDA experts report that saline or silicone-gel implants may well rupture while women go through mammograms. Because of this, women who are concerned about possible breakage of  their implants could be reluctant to go for mammograms, thereby placing themselves at risk from undetected cancer.
• The accuracy and reliability of mammograms usually decrease as the dimensions of the implants, in ratio to the dimensions of the woman's natural breasts, increase.

Research results on whether or not implants cause delays in the diagnosis of breast cancer have not been consistent, but such delays have been reported by individuals. Delayed diagnosis could lead to a requirement of more radical surgical procedures, or it could be life-threatening.

Issues with Concentration and Memory. Women with breast implants have brought up worries regarding loss of memory, difficulties in concentration, along with other cognitive difficulties. FDA's analysis of research by implant organizations discovered significantly higher incidence of neurological disorders, like below average concentration, in women who had silicone-gel implants for 2 yrs when compared to their indicators just before having the implants inserted. These increases in neurological disorders remained statistically significant even after adjusting for age. A few experts from the American Chemical Society believe these signs and symptoms might be related to the small quantities of platinum which are used in the manufacture of silicone-gel implants, because platinum at levels that could be toxic have been seen in the blood as well as urine of women with silicone implants.

Regrettably, there isn't any well-designed epidemiological research published to ascertain if there exists any connection between these types of problems and breast implants.

Monetary Factors. Surgical breast augmentation with implants involves more than a one-time expense. Generally, implants last for seven to twelve years on average. Every replacement is additional expense. Even when the implant is replaced at no cost, or even if the cosmetic surgeon provides his/her services free of charge, the cost of the surgery center, the cost of anaesthesia, along with other charges can still add up to several thousands of dollars for every re-operation. Some women may be able to afford such expenses, but not all. The financial burden could become particularly difficult if the implant should rupture after only a few months or few years after insertion, or shortly after a divorce or a  loss of one's job.

While approving silicone-gel breast implants in November 2006, the FDA advised that women with these types of implants need to have a breast MRI 3 years after insertion of the implants and every couple of years thereafter. The objective of the MRIs is to detect ruptures or leakages in the implants because frequently there are no indications of such ruptures/leakages. Breast MRIs typically cost a minimum of $2,000, and at some establishments the costs are double that figure. If a silicone-gel implant ruptures, it is necessary to have it removed to prevent the silicone moving into the breast or lymph nodes. Silicone implant removal will involve a further cost of a minimum of $5,000 and could be higher, even up to $10,000.

With saline implants, MRIs for detecting leakages are not needed. In most cases, removal of saline implants cost less than $5,000. The expenditure on MRIs and the higher cost of silicone implant removal makes these types of implants considerably more costly than saline ones.

How about medical insurance? As a rule, the costs of cosmetic surgery or any issues arising from such surgery will not be covered by medical insurance. The cost of MRIs for silicone leakage detection in breast enlargement cases will also not be covered by health or medical insurance. In certain states, the main health insurance companies will not even accept women who have breast implants for insurance coverage. Several insurance companies will insure women with breast implants, but charge them higher premiums. Some insurance firms will not cover some types of ailments - or any sickness in the breast region - for women who have any kind of breast implants. Clearly, for women who unfortunately develop cancer of the breast, or any other ailments that the insurer has excluded, this would be a huge problem. This might occur irrespective of whether those conditions are associated with the implants or not.

What happens if I have to have my implants taken out?

Women with breast implants at times choose to have the implants taken out, perhaps due to problems they are experiencing or dissatisfaction with the appearance and/or feel of their breasts or worries concerning the health risks in the long term. Some surgeons will try to persuade their patients not to have their implants removed. This can be because they do not share the patient's worries about problems or health hazards, or perhaps because they are sure that most women will be extremely dissatisfied with how they will look once the implant is taken out. Women, whose silicone implants have ruptured, lose some breast tissue in the process of implant removal. If there is silicone leakage into the breast tissues, the removal procedure could be just like a mastectomy.

The surgeon who carried out the initial implant surgery may not always be the best option for implant removal. Implant removal is often a lot more complex and costly than the breast augmentation surgery, especially if there is a rupture of a silicone-gel implant. Certain cosmetic surgeons have become highly experienced at removing implants and have acquired specific skills for achieving the best aesthetic outcome possible in these circumstances. Most surgeons specializing in implant removal advise "en bloc" removal of the implants, meaning the implant and the surrounding capsule of scar tissue are taken out together. This ensures elimination of any silicone that could have leaked out from a ruptured silicone-gel implant, and additionally helps eliminate any other chemicals that could have leaked from the external envelope of silicone.

Are there new developments in implants that are safer?

Among new developments in breast implants, cosmetic surgeons occasionally offer what they call "gummy bear" breast implants. These implants use silicone-gel which is thicker and more cohesive than regular implants. Because the shell and gel in these more recent models are thicker than the normal silicone implants, possibly they will not rupture or the silicone-gel will not leak out of the implant into the body, as easily as the conventional implants.

However, new types of implants can have other hazards that might not be immediately evident. Regrettably, there is no published record of studies conducted to establish that these new types of implants are indeed safer over long term usage than conventional silicone-gel breast implants. At this time, it's impossible to know if the thicker shell will indeed last for a longer time than the conventional implants and, if they do, how much longer that will be - one year or many years. It will be only after these thicker gel implants have been in women for ten years or longer, that we will know if and just how the implant remains stable or changes when it is inside the human body. The FDA has not yet approved these new types of implants because very little is known regarding their long-term durability and safety.

The importance of long-term safety studies. Other than saline and silicone implants, there are three other type of breast implants have been developed in the past and used mainly outside the U.S.: Trilucent implants using soybean oil filler, and Novagold and PIP hydrogel implants, both of which contain a plastic gel as the filler.

These implants were initially promoted with enthusiasm by cosmetic surgeons and the media, as a more "natural" and a safer alternative to saline or silicone-gel implants. However,  apparently clinical trials with women were never carried out on these types of implants. By the year 2000, serious apprehensions about the safety of these implants were raised in the UK, culminating in the removal of all these three types from the marketplace. The fact that these implants had initially been enthusiastically promoted and accepted both by surgeons and by patients when they were originally launched is a pointer to the fact that the risks involved in long-term usage of any type of breast implant are not immediately apparent during the initial few years of usage. For this reason, long-term safety studies are vitally important to determine the safety of any type of breast implant. Unfortunately, such long term studies are still lacking for even conventional silicone implants.

Conclusions

Investigations and research studies clearly show that there are very real health, aesthetic, and monetary concerns associated with breast implants within even the first few years of usage. Also, the risks increase with the passage of time. Regrettably, long-term dangers continue to be unknown due to a lack of credible scientific research. FDA has directed implant makers to carry out additional investigation to find out the reasons for breakage of implants, the length of time they can realistically be expected to last, and the possible long-term health implications of ruptured implants and leakages from these implants. However, the outcome of those studies have not so far been published.