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A debate on the dangers or safety of breast implants for women

The popularity of breast augmentation has almost tripled since 1997, when there were just over 101,000 of these procedures. Many women are justifiably confused by the conflicting information they hear. Here are the facts about what is known and not known about the risks of breast implants.

After a brief history of breast implants in the U. What are the known risks? What happens when breast implants break? Do breast implants make women sick? What are other concerns? What if I need to get my implants removed?

Long-Term Consequences of the Breast Implant Debate

Are there newer, safer implants? History of Implants in the US Breast implants made with silicone envelopes and filled with silicone gel or saline salt water were first sold in the United States in the 1960s, but sales were relatively slow until the 1980s.

By 1990, however, almost one million women had undergone breast implant surgery, even though no safety studies had been published.

Most of those women had silicone gel breast implants, which the plastic surgeons preferred. Although most medical products must be proven safe and effective before they can be sold in the U. The Food and Drug Administration FDA did not require that companies selling silicone breast implants prove that their implants were safe until 1991 — after they had been in use for almost three decades. For the first time, the media started to report about women with implant problems, and quoted doctors who were concerned about implant safety.

The FDA did not require implant makers to prove that their saline implants were safe until 2000, when, despite high complication rates, the FDA approved saline breast implants for the first time. Silicone gel breast implants were approved for the first time in November 2006. Between 1992 and 2006, silicone implants were restricted to clinical trials that were primarily for cancer patients and women with broken implants.

Patients were required to be informed that the implants were not approved by the FDA and to be regularly evaluated by their plastic surgeons as part of the study, in order to provide safety data intended to help all women with gel implants. Although silicone gel breast implants made by two manufacturers were approved in November 2006, there are still restrictions. For example, they are only approved for women over the age of 22, because younger women are still developing physically and emotionally and probably would not fully understand the risks.

  1. What effect that might have on a woman, or a nursing baby, has not been studied.
  2. Are there newer, safer implants? The father of a boy with hydrocephalus testified of his fear that hydrocephalus shunts, which contain silicone, may become unavailable.
  3. This is likely due to delays in breast cancer detection because of implants. Even if the implant itself is replaced for free, or if the surgeon offers his or her services for free, the cost of the medical facility, anesthesiology, and other expenses can still cost many thousands of dollars for each surgery.

What are the Known Risks? Reports of complications among women with implants have been published in medical journals and discussed at public FDA meetings. There are a number of short-term and long-term risks that any woman thinking about getting breast implants or about removing or replacing older implants needs to be aware of. Studies of saline breast implants and silicone gel breast implants conducted by implant manufacturers have shown that within the first three years, approximately three out of four reconstruction breast cancer patients and almost half of first-time augmentation patients experienced at least one local complication — such as pain, infection, hardening, or the need for additional surgery.

The FDA has a consumer handbook with descriptions of common complications as well as photographs, available to consumers here. The estimates were much lower in the U. Given the dramatic increase in diagnoses in recent years, it is clear that BIA-ALCL was under-diagnosed and under-reported for many years. In addition to the risks from anesthesia, surgical risks include infection and hematoma blood collecting around an implantboth of which can range from mild to severe.

Surgical risks are highest immediately around the time of surgery, but complications can require additional surgery later, which will have similar risks. A woman may need to face these surgical risks several times if she needs surgery to correct implant problems or has broken or damaged implants replaced with new ones. Common local complications include loss of nipple sensitivity or painfully sensitive nipples.

Problems like these can interfere with sexual intimacy. Scar tissue that forms around any implant or foreign body can become hard or tight around the implant. This common problem is called capsular contracture. The scar tissue is inside the body, but it can cause the breasts to become very hard and misshaped, and it leads to discomfort that ranges from mild to severely painful. What effect that might have on a woman, or a nursing baby, has not been studied.

What Happens When Implants Break? All breast implants will eventually break, but it is not known how many years the breast implants that are currently on the market will last.

Studies of silicone breast implants suggest that most implants last 7-12 years, but some break during the first few months or years, while others last more than 15 years. In a study conducted by FDA scientists, most women had at least one broken implant within 11 years, and the likelihood of rupture increases every year. Implant makers were required to study breakage and provide their studies to the FDA.

Research has shown that silicone gel in implants can break down to liquid silicone at normal body temperatures, and there are reports of silicone leakage and migration from implants to the lymph nodes and other organs.

  • Here are the facts about what is known and not known about the risks of breast implants;
  • Are there Newer, Safer Implants?
  • History of Implants in the US Breast implants made with silicone envelopes and filled with silicone gel or saline salt water were first sold in the United States in the 1960s, but sales were relatively slow until the 1980s.

A study published by the Royal Academy of Medicine in Scotland found that a woman with a broken silicone gel implant in her calf was coughing up silicone identical to the kind in her implant. A more controversial question is whether breast implants cause diseases or illnesses, and not just problems in the breast area. Studies conducted after those reports were published indicated that implants might be linked to a number of diseases.

Do implant patients who have autoimmune symptoms feel better if their implants are removed?

What You Need to Know About Breast Implants

As mentioned above, breast implants can cause a type of cancer of the immune system called ALCL. More research is needed to draw any conclusions, however. There is no research evidence that implants cause breast cancer. However, implants can interfere with detection of breast cancer.

Mammograms have been shown to detect breast cancer earlier, potentially saving lives as well as saving women from needed mastectomies. There are several ways in which implants have the potential to delay detection of breast cancer: Although mammography can be performed in ways that minimize the interference of the implants, approximately 55 percent of breast tumors will be hidden in women with implants.

Patients have reported that their implants delayed their breast cancer diagnosis. This is likely due to delays in breast cancer detection because of implants. A 2013 Canadian meta-analysis of five studies found that if women who had breast augmentation later developed breast cancer, they were more likely to die from it than women diagnosed with breast cancer who did not have breast augmentation.

This increased risk of breast cancer-specific death is likely to be due to the greater inaccuracy of mammography for women with implants. However, more research is needed to better control for relevant health habits.

Three Scandinavian studies have reported that women who had breast implants for augmentation were three times more likely to commit suicide compared to women in the general population.

  1. That is why studies of the risks of long-term use — which are still lacking for silicone implants — are essential to establish the safety of all kinds of implants. Obviously, this can be a terrible problem for women who are diagnosed with breast cancer or any other illnesses that are excluded, whether or not those diseases are related to the implants.
  2. In a study conducted by FDA scientists, most women had at least one broken implant within 11 years, and the likelihood of rupture increases every year.
  3. Why long-term safety studies matter.
  4. Implant makers were required to study breakage and provide their studies to the FDA. Some surgeons discourage patients from removing their implants.
  5. Taken altogether, the studies have failed to find an association, although they are not large enough to rule out some small effect.

According to the Institute of Medicine IOMwomen with any kind of breast surgery, including breast implant surgery, are at least three times as likely to have an inadequate milk supply for breastfeeding.

A study of a small number of women with silicone gel breast implants found that the offspring born and breastfed after the mother had breast implants had higher levels of a toxic form of platinum in their blood than offspring born before the same women had breast implants.

Women with implants have raised concerns about memory loss, difficulties with concentration, and other cognitive problems. Breast implant surgery is not a one-time cost. On average, implants last 7-12 years, and each replacement adds to the cost.

  • What about health insurance?
  • Studies of silicone breast implants suggest that most implants last 7-12 years, but some break during the first few months or years, while others last more than 15 years;
  • See second photo here;
  • By 1990, however, almost one million women had undergone breast implant surgery, even though no safety studies had been published;
  • In addition to silicone and saline implants, three other kinds of implants were developed and used primarily outside the United States:

Even if the implant itself is replaced for free, or if the surgeon offers his or her services for free, the cost of the medical facility, anesthesiology, and other expenses can still cost many thousands of dollars for each surgery. These expenses are affordable for some women, but not for others, especially if the implant breaks after just a few months or years, or after a woman is divorced or loses her job.

  • Do breast implants make women sick?
  • By 1990, however, almost one million women had undergone breast implant surgery, even though no safety studies had been published;
  • The plastic surgeon who performed the original surgery is not necessarily the best choice for removing the implant;
  • None of them, even foreign suppliers, would deal with American manufacturers because of the liability risks;
  • They certainly extend beyond the question of whether breast implants are safe, important though that question is;
  • From a public health perspective, of course, a doubling of risk may matter, and it certainly would from the perspective of scientists interested in the pathogenesis of disease.

When the FDA approved silicone gel breast implants in November 2006, it stated that women with these implants should have a breast MRI three years after getting silicone implants and every two years after that. It is important to remove silicone implants if they are ruptured, to avoid the silicone leaking into the breast or lymph nodes. The cost of MRIs and the additional cost of removing leaking silicone makes silicone implants substantially more expensive than saline.

What about health insurance? Typically, cosmetic surgery is not covered by health insurance, and problems resulting from cosmetic surgery are also not covered. In some states, major health insurance providers do not insure women with breast implants.

Obviously, this can be a terrible problem for women who are diagnosed with breast cancer or any other illnesses that are excluded, whether or not those diseases are related to the implants.

Women who have implants sometimes decide to have them removed because of complications, disappointment with how they look or feel, or concern about the long-term health risks. Some surgeons discourage patients from removing their implants. See photo 3 here Women with ruptured silicone implants often lose breast tissue as part of the removal surgery.

If silicone has leaked into the breast tissue, the resulting removal surgery may be similar to a mastectomy.

Current Issue

See second photo here. The plastic surgeon who performed the original surgery is not necessarily the best choice for removing the implant. Removal can be much more complicated and expensive than the original surgery, especially after a silicone gel implant has broken. Some plastic surgeons are very experienced at removal and are especially skilled at getting the best possible cosmetic result. Are there Newer, Safer Implants?

Since the shell and gel in these newer models are thicker than most other silicone gel implants, it is possible that they might be less likely to break or leak into the body.

Only when the cohesive gel implants are in women for more than 10 years will we know whether and how the implant deteriorates or changes when it is in the human body. Why long-term safety studies matter. In addition to silicone and saline implants, three other kinds of implants were developed and used primarily outside the United States: Trilucent implants with soybean oil fillerand Novagold and PIP hydrogel implants, which were filled with a plastic gel.

By 2000, serious safety concerns resulted in the removal of all three from the market. That is why studies of the risks of long-term use — which are still lacking for silicone implants — are essential to establish the safety of all kinds of implants. Conclusions Research clearly shows that implants are associated with significant health, cosmetic, and economic risks within the first few years and these risks increase over time.

Unfortunately, long-term risks remain unknown because of a lack of careful scientific studies. FDA has required implant manufacturers to conduct additional research to determine why implants break, how long they can be expected to last, and what the longer-term health consequences of broken and leaking breast implants might be.

Those studies, however, have not yet been made public.