All posts by BIeditor

Massive Marketing Muscle Pushes 3D Mammograms, Despite No Evidence They Save More Lives, Investigation Shows

Liz Szabo, USA Today: October 18th, 2019.


When Dr. Worta McCaskill-Stevens made an appointment for a mammogram last year, she expected a simple breast cancer screening – not a heavy-handed sales pitch.

A receptionist asked if she wanted a free upgrade to a “3D mammogram,” or tomosynthesis.

“She said there’s a new approach and it’s much better, and it finds all cancer,” said McCaskill-Stevens, who declined the offer.

A short time later, a technician asked again: Was the patient sure she didn’t want 3D?

Upselling customers on high-tech breast cancer screenings is just one way the 3D mammography industry aggressively promotes its product.

A KHN investigation found that manufacturers, hospitals, doctors and some patient advocates have put their marketing muscle – and millions of dollars – behind 3D mammograms. The juggernaut has left many women feeling pressured to undergo screenings, which, according to the U.S. Preventive Services Task Force, haven’t been shown to be more effective than traditional mammograms.

[…]

The American Cancer SocietySusan G. Komen and the U.S. Preventive Services Task Force also say there isn’t yet enough evidence to advise women on 3D mammograms.

When the Food and Drug Administration approved the first 3D mammography system, made by Hologic, the agency required the technology to be safe and effective at finding breast cancer – not at improving survival.

“The companies do the minimal research needed to get FDA approval, and that usually means no meaningful evidence of how it helps patients,” said Diana Zuckerman, president of the National Center for Health Research.

Valenti said Hologic presented strong evidence to the FDA. “The data was overwhelming that 3D was a superior mammogram,” Valenti said.

Describing a breast exam as 3D may conjure up images of holograms or virtual reality. In fact, tomosynthesis is closer to a mini-CT scan.

Although all mammograms use X-rays, conventional 2D screenings provide two views of each breast, one from top to bottom and one from the side. 3D screenings take pictures from multiple angles, producing dozens or hundreds of images, and take only a few seconds longer.

Yet some studies suggest that 3D mammograms are less accurate than 2D.

A 2016 study in The Lancet Oncology found that women screened with 3D mammograms had more false alarms. A randomized trial of 29,000 women published in The Lancet in June showed that 3D detected no more breast tumors than 2D mammograms did.

And, like all mammograms, the 3D version carries risks. Older 3D systems expose women to twice as much radiation as a 2D mammogram, although those levels are still considered safe, said Diana Miglioretti, a biostatistics professor at the University of California-Davis School of Medicine.

Valenti said the newest 3D systems provide about the same radiation dose as 2D.

Diagnosing more cancers doesn’t necessarily help women, Brawley said. That’s because not all breast tumors are life-threatening; some grow so slowly that women would live just as long if they ignored them – or never even knew they were there. Finding these tumors often leads women to undergo treatments they don’t need.

2017 study estimated 1 in 3 women with breast cancer detected by a mammogram are treated unnecessarily. It’s possible 3D mammograms make that problem worse, by finding even more small, slow-growing breast tumors than 2D, said Dr. Alex Krist, vice chairman of the U.S. Preventive Services Task Force, an expert panel that issues health advice. By steering women toward 3D mammograms before all the evidence is in, “we could potentially hurt women,” Krist said.

Some experts worry that patients, who tend to overestimate their risk of dying from breast cancer, are acting out of fear when they choose treatment.

“If there was ever an audience susceptible to direct-to-consumer advertising, it’s women afraid of breast cancer,” Zuckerman said.

Some proponents of 3D mammograms imply that women who opt for 2D are taking a risk.

The first question many women have about 3D mammograms is: Are they less painful?

In ads, Hologic claims its 3D device was less painful for 93% of women. But that claim comes from a company-funded study that hasn’t been formally reviewed by outside experts, Zuckerman noted. Given the limited data provided in the study, it’s possible the findings were the result of chance, said Zuckerman, who called the ads “very misleading.”

Valenti said peer review is important in studies about cancer detection or false alarms. But when it relates to “general patient satisfaction or patient preference, those are data that we get in other ways,” he said. “Plenty of [doctors] have the [3D] system now and you can get feedback from them. “

While screenings may not generate a lot of income, they can attract patients who need other, more profitable hospital procedures.

“Anytime you diagnose more tumors, you can treat more tumors,” said Amitabh Chandra, director of health policy research at Harvard University’s John F. Kennedy School of Government.

Click here to read the full article.

Alternatives to Breast Implants: Lifts and Fat Transfers


When considering cosmetic breast augmentation, women typically consider implants as their main option. However, there are several other procedures to change how your breasts look that may have fewer risks and complications compared to breast implants. These alternatives include breast lifts and fat transfers.

Breast Lifts

Breast lifts, clinically called a “mastopexy,” raise and reshape the breasts. Surgeons remove extra skin and tighten surrounding tissue. In addition to reshaping the breasts, a lift can reposition the nipple and reduce the size of the areola if it has become enlarged over time. Many women choose to get breast lifts to improve the stretching or sagging of their breasts that could have been caused by pregnancy, weight fluctuations, and simple gravity. A breast lift alone cannot make breasts larger, but breasts will look fuller and more perky after the procedure. 1

There are four types of breast lift techniques, which depend on breast and areola size and shape, degree of sagging, amount of skin that must be removed, and the elasticity of skin. For women who have smaller breasts or minor sagging, a crescent or donut technique can be used to create small incisions around the areola. For women who have larger breasts and more severe sagging, surgeons will need to create multiple incisions, either around the areola and vertically down the middle of the breast (a lollipop technique) or including a horizontal incision along the breast crease (an anchor technique). 2

Swelling and bruising will last for about two weeks, and numbness may last up to six weeks. Final results of breast lifts will appear over the months following the procedure as the breasts settle into their new shape and position. Results of a breast lift procedure are long-lasting, especially with a healthy lifestyle. Women with smaller breasts will likely have results that last longer than women with larger breasts. It is also important to note that the cosmetic appearance of the breasts can change due to pregnancy, breast feeding, and significant weight changes that occur after surgery. Therefore, women should consider whether they are planning a pregnancy in the near future before having a breast lift. 3

Risks of Breast Lifts 

When considering a breast lift, it is important to consider the risks of the procedures in addition to the benefits. For breast lift procedures, the most common risks include changes in nipple or breast sensation, asymmetrical breast shape, and partial or total loss of the areola.1 Less common risks that some patients experience are bleeding or hematoma formation, infection, poor incision healing, fat necrosis (fatty tissue around skin may die), and fluid accumulation. Although patients will have scars from a breast lift procedure, many notice that some scarring is hidden in natural contours of the breasts and that scars improve over time, typically within one year.3 As with any cosmetic procedure, some patients may be unhappy with the final result. Your chances of getting the results you want will be better if you choose a board certified plastic surgeon with a lot of experience doing breast lifts without breast implants.

Some plastic surgeons recommend getting both a breast lift and implants to get the best cosmetic result. However, that means patients will face the risks of the lift and the additional risks of the implants. While the breast lift procedure alone is safer than getting implants, there is still a lack of safety data and research on breast lifts to know how often complications occur in the solo procedure. The skill and experience of the plastic surgeon makes a big difference.

Fat Transfer

Fat transfers may be a good option for women who want to have more natural looking, fuller breasts without implants. Fat transfers use liposuction to remove fat from other parts of the body and insert it into the breasts. Fat for liposuction is typically taken from areas such as the back, thighs, abdomen, and buttocks. 4 Next, the fat cells are processed into a liquid so they can be injected into the breast area. 5 The surgeon will slowly inject the fat liquid to multiple areas of the breast until the desired breast size is achieved. Since the procedure uses body fat from the patient, thin women may not be good candidates for this procedure. Because the injected fat does not contain its own blood supply, only a small amount of fat can be injected at a time. Patients should not expect to gain more than one cup size. 

Patients typically notice improvement right after the procedure, but the final results will appear one year after surgery when swelling has gone down. Multiple follow-up fat transfer procedures may be necessary to maintain the shape of the breasts. In many cases, fat that has been injected into the breasts may be reabsorbed by the body over time, move to other parts of the body, or die, causing breasts to lose volume.5 Therefore, surgeons may recommend follow-up sessions to repeat the procedure, which may be expensive and is an important factor to consider.

Risks of Fat Transfers

High patient and surgeon satisfaction as well as low complication rates have been reported for fat transfer procedures, but outcomes vary greatly based on the surgeon as the procedure is not yet standardized. 6, 7 The most common complications from fat transfers include development of cysts (lumps) or fat necrosis, which is when the transferred fat dies and is reabsorbed by the body. 8 Fat necrosis is more common when a large amount of fat is injected. This usually does not need to be treated, as the body takes care of the dead cells on its own. 

Other less common complications can include infection and calcification of the fat.8 Like fat necrosis, these complications are more common when a large amount of fat is injected. Because the injected fat does not have its own blood supply, too much injected fat may lead to microcalcifications, which is when the fat hardens. These calcifications are usually harmless, but they may look like breast cancer on a mammogram, resulting in stressful and expensive breast biopsies.

Bottom Line

Despite risks, lifts and fat transfers appear to be safer than breast implants. Breast implants are not lifetime devices, and women should expect additional surgery to replace them every 10-15 years if not more often. Health insurance often does not pay for removal or complications for augmentation patients and never pays for replacement of cosmetic implants. The high cost of these additional surgeries, as well as the common complications from implants, make lifts and transfers a safer option for many patients.

While breast lifts and fat transfers provide alternatives to breast implants for cosmetic breast enhancement, patients must consider the risks of both procedures before choosing to undergo surgery. More long-term research is needed to confirm the safety and effectiveness of both procedures.

When deciding whether or not to undergo cosmetic breast augmentation, it is important to weigh the risks and benefits of each procedure with a highly skilled, experienced surgeon who is board certified in plastic surgery, so you can make a decision that is right for you. 

NCHR Comment on FDA’s 510(k) Third Party Review Program Draft Guidance

National Center for Health Research: December 13, 2018


Comment of the National Center for Health Research Regarding the
510(k) Third Party Review Program:
Draft Guidance for Industry, FDA Staff, and Third Party Review Organizations.
OMB Control Number 0910-0375

The National Center for Health Research (NCHR) is a non-profit organization which conducts original research to better inform policy makers, health professionals, and patients.   NCHR accepts no funding from any entity which manufactures or distributes medical products.

We appreciate the opportunity to comment on this draft guidance.  We note that this draft guidance applies to low-to-medium risk medical devices, which concerns us because many Class II devices are permanent implants that have the potential to cause permanent harm to patients.  In fact, our research indicates that even Class I devices have been subjected to high-risk recalls by the FDA due to the potential for causing death or permanent harm.1 2 3

We have several serious concerns about the draft guidance.  First, Original Equipment Manufacturers (OEM) are accountable for the efficacy and safety of their medical devices.  FDA standards require that devices manufactured by OEM’s comply with relevant regulatory standards.  OEMs are required to track, monitor, and report product issues to FDA.  Overseeing the OEMs and their reporting are FDA’s responsibility to ensure patient safety.

Second, in the past FDA has had the opportunity to review the work of any third party reviewer, and reject it if deemed inadequate or shoddy.  In fact, the agency has often found problems with the third party reviews.  The proposed guidance would sharply reduce the agency’s oversight of third party reviews, which will clearly compromise safety.  Even if certified as qualified, third party review companies have an inherent conflict of interest: If their standards are too high, no device company will hire them and they will go out of business.  The system is similar to the EU regulation of medical devices, which has resulted in very harmful decisions, such as the clearance of the PIP breast implants that were found to use non-medical grade silicone.4  In addition, investigative reporters recently obtained CE clearance for a “surgical” mesh that was made out of a plastic mesh bag used for oranges.

Transparency is also a crucial factor.  Currently, third party review companies are not required to clearly label an OEM device indicating that a critical repair has been completed by someone other than the OEM.  Once that repair is made, the device is no longer the same device that was approved or cleared by FDA.  It is important that this chain of accountability is not broken or interrupted.

While we understand the desire of FDA officials to reduce medical device review times and reduce the burden on FDA staff and industry, the 510(k) program already is a quick way to get devices to market and the device industry has clearly benefitted from it.  The 510(k) pathway has been widely criticized by the Institute of Medicine, physicians, patients, and the media for its lack of clinical trials and lack of scientific evidence.5  Despite its weaknesses, the 510(k) pathway is considered superior to the EU regulatory system, however.  By reducing the “burden” for FDA staff and industry, the proposed guidance increases the burden on patients and doctors to figure out which devices are safe and which are not.  This would clearly put U.S. patients at greater risk.

FDA has not demonstrated that its proposed changes to the third party review pathway of Class I and Class II devices will benefit patients.  By definition, 510(k) devices only rarely are substantially superior to recent predicates.  Speeding up the process of clearance is not demonstrated to benefit patients.  Moreover, with registries, NEST, and other planned efforts to improve post-market surveillance still far from effectively implemented, any loosening of 510(k) regulations is very premature.

Finally, we note that Commissioner Gottlieb responded to recent media criticism of CDRH regulations by promising improvements to the 510(k) pathway to ensure patient safety.  The third party review program clearly moves in the opposite direction, reducing patient safety, rather than protecting patients from potentially harmful devices.   We strongly oppose it for that reason.

 

References

  1. Zuckerman, D.M., Brown, P, and Nissen, S.E.  (2011) Medical Device Recalls and the FDA Approval Process, Archives of Internal Medicine, 117, 1006-11.
  2. Zuckerman D.M., Brown P., Nissen S.E. (2011). In Reply, Archives of Internal Medicine, 171(11), 1045.
  3. Zuckerman D.M., Brown P., Nissen S.E. (2011). In Reply, Archives of Internal Medicine, 171(21), 1963.
  4. Zuckerman, D., Booker, N, and Nagda, S. (2012) Public Health Implications of Difference in US and European Union Regulatory Policies for Breast Implants, Reproductive Health Matters, 20 (40),102-111.
  5. Zuckerman D.M., Brown P. & Das A. (2014) Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices,  JAMA Internal Medicine, 174(11): 1781-1787.

 

Capsular Contracture


After getting breast implants, breast pain, hardness, and numbness can develop and last for years. These common complications may never go away. The most common complication of breast implants is capsular contracture. When you get breast implants, your body naturally responds to the foreign object by forming scar tissue around the implants. Capsular contracture occurs when the scar tissue tightens around the breast implant. This can cause the breast to harden and become very painful. It can also change the shape of the implant, making it look abnormal, as shown in the photo below.

A 29-year-old woman with Baker Grade IV capsular contracture. Photo courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.

To fix capsular contracture, doctors used to perform a “closed capsulotomy.” This painful procedure involves squeezing the breast very hard to break the scar tissue capsule. This procedure should never be done. Most plastic surgeons do not perform this procedure anymore, but some do. The squeezing can break the implant and the capsule. Closed capsulotomies are not effective, and capsular contracture often comes back.

A plastic surgeon will be able to diagnose capsular contracture through a physical and visual exam. There are different grades of capsular contracture (Baker I, Baker II, Baker III, and Baker IV). They are graded based on the severity of symptoms:

Baker Grading System for Capsular Contracture

Baker I Breast is soft
Baker II Breast is slightly firm
Baker III Breast is firm and possibly misshapen and uncomfortable
Baker IV Breast is hard, painful, and misshapen

Health insurance companies that will pay for breast implant removal usually cover removal when there is severe capsular contracture (Baker III and Baker IV). This is because severe, painful capsular contracture interferes with mammography (breast cancer screening). The pain from severe capsular contracture can also interfere with daily activities, such as reaching above your head.

Capsular contracture does not usually get better by itself. If your breasts become very painful or hard, you will need surgery. Your surgeon would need to remove the scar tissue capsule and the implant. It is possible that some of your own breast tissue will be removed during the surgery because it is attached to the scar tissue. This can reduce the size of your natural breast and/or change their appearance.

If you decide to have your breast implants removed and replaced, it is important to know that capsular contracture is likely to reoccur. Women who have already had capsular contracture are at an increased risk of developing capsular contracture again with their replacement implants. This could lead to an endless cycle of surgeries, so the best treatment option for capsular contracture is permanent removal of the breast implants.

 

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

 

Rupture


If an implant tears or develops a hole, it is called a rupture. Some implant ruptures happen during the first few months, but the older an implant is, the more likely it is to rupture. It’s not always obvious when an implant has ruptured. Here’s what you need to know.

Saline Implant Ruptures

When a saline (salt water) breast implant ruptures, it will probably leak very quickly. The implant deflates much like a balloon that has lost the air inside. As this happens, your breast will change in size and/or shape. If a saline implant leaks slowly, it might not be immediately noticeable. When the saline leaks, the body absorbs it. It is usually harmless unless bacteria, yeast, or mold are inside the implant. They can cause a serious infection. If you notice a change in the size or shape of your saline implant along with symptoms like swelling, redness, or fever you should see a doctor immediately.

Silicone Implant Ruptures

When a silicone gel breast implant ruptures, it usually leaks very slowly. A ruptured silicone gel implant may not be obvious for many years. This is why silicone gel implant ruptures are sometimes called “silent” ruptures. Sometimes, the rupture is discovered only when the implant is removed.

When a silicone implant ruptures, the silicone can either stay inside the capsule (the thick layer of scar tissue that naturally grows around the implant) or it can leak outside the capsule. It is more serious when the silicone leaks outside of the capsule. When this happens, silicone can migrate to the lymph nodes, and from there can go to the lungs, liver, or other organs where it’s impossible to remove. The longer a woman waits to have a ruptured silicone gel implant removed, the more silicone is likely to leak inside her body and cause health problems.

How Do I Find Out If My Silicone Implant Has Ruptured?

If your silicone gel implant ruptures, you might notice a change in the size or shape of your breast. You might feel pain or tenderness, swelling, numbness, burning, or tingling. Or, you might not have any symptoms, making it impossible to know you have a rupture.

Because most women don’t notice when a silicone gel implant ruptures, the FDA recommends having a breast MRI 3 years after getting breast implants. After that, a breast MRI should be done every other year to check for a rupture.

A mammogram is the least accurate way to diagnose a ruptured silicone-gel breast implant. In addition, the pressure could cause the silicone to leak outside the capsule.

What Should I Do If My Implant Ruptures?

If your saline implant has ruptured, you should see a doctor. This is especially important if you feel sick, have a temperature, a rash, or other unexplained symptoms. You could have an infection and require treatment.

If you have ruptured silicone gel implants, they should be removed as soon as possible. The longer the silicone is allowed to remain in the body, the more time it has to migrate to other parts of your body. Once the silicone has moved to other parts of your body, it can’t be removed and may cause other health problems. Just as important as having leaking silicone gel implants removed, is having them removed en bloc. En bloc removal is when the scar tissue (or capsule) and implant are removed at the same time, with the implant still inside the intact scar tissue capsule.  En bloc removal allows the silicone and other chemicals to stay inside the intact scar tissue capsule as it is removed. En bloc removal prevents silicone and other chemicals from leaking into the woman’s body during surgery. It requires a larger incision but it is worth it because it prevents leakage.

Since breast implant removal includes costs (such as anesthesia) that are similar whether you have one implant removed or two, it is usually best to remove them both at the same time, whether or not you want them to be replaced. For example, if your implants were put in at the same time, and one is ruptured, it is likely that the other will rupture soon. One surgery is much less expensive than two.

Can Broken Implants Make Me Sick?

According to research by FDA scientists, women with leaking silicone implants are more likely to report fibromyalgia (widespread body pain and fatigue) or several other diseases, compared to women whose implants are not leaking.9 One study found that 3 out of every 4 women who removed their silicone breast implants saw improvement in their symptoms.10

No research has been published on the health risks of broken saline implants but bacteria from ruptured saline implants have caused women to become ill.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Extrusion, Pain, and Cosmetic Complications


Extrusion

Extrusion is when a breast implant comes through the skin and becomes exposed. It is an uncommon, but dangerous, complication of breast implant surgery. It typically occurs if the incision wound does not heal properly, the tissue dies (necrosis), or there is not enough breast tissue and skin to support the implant.  

Certain factors can increase the risk of extrusion due to improper wound healing. They include:

  •        Breast implants that are too big
  •        Underlying health issues, such as diabetes
  •        Women who smoke
  •        Overexertion, especially right after surgery
  •        Radiation therapy for breast cancer

Extrusion requires additional surgery, which may cause scarring or loss of breast tissue.

Neck, back, and chest pain

The added weight of breast implants can strain the muscles in your neck, back and chest, resulting in pain and poor posture. Muscle strengthening exercises can offer pain relief, but implant removal is needed if the pain doesn’t go away.    

Appearance

Sometimes breast implant surgery can have disappointing cosmetic results. If you are unhappy with how you look, another surgery might be required, which can be emotionally, financially, and physically stressful. The risk of an undesirable outcome can be reduced (but not eliminated) by choosing an experienced, board-certified surgeon. The following are few examples of complications that can give you a less than desirable outcome:

  •        Asymmetry — uneven size, shape and/or level of breasts
  •        Implant displacement or malposition — when the implant moves from the correct position
  •        Implant wrinkling or rippling
  •        Ptosis — breast sagging, which will happen over time due to the weight of the implant, breastfeeding, or the natural result of aging

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Are Your Breast Implants Poisoning You?

Johane van den Berg, Longevity: June 18, 2018.

Victoria Beckham, Crystal Hefner, Pamela Anderson, Yolanda Hadid, Melissa Gilbert and Heather Morris. What do these famous women have in common with thousands of other women worldwide? Well, for one thing, they all decided to get breast implants when they were younger. And now all of them have decided to remove what many are referring to as their “toxic bags”.

After their arrival on the cosmetic-surgery market in the 1960s, both silicone and saline breast implants quickly became the most popular plastic surgery procedure for women. According to the American Society of Plastic Surgeons, breast augmentation is still the number one surgical procedure for women, ranking above liposuction, nose reshaping, eyelid surgery and the tummy tuck. The problem, explains Dr Diana Zuckerman, Ph.D. and President of the National Centre for Health Research in the United States, is that surgeons who administer breast implants often minimize the risks associated with this procedure. Consequently, the majority of women don’t realize that a few years after the procedure, they may need to have their implants removed. Additionally, they are unaware that removal costs at least as much as implantation. […]

Now, about 50 years after breast implants were first introduced globally, un-tracked numbers of women are complaining of a recognizable pattern of health problems, which they attribute to their implants. Those suffering from these symptoms generally refer to the condition as Breast Implant Illness or BII (although non-medical, this term is widely used). Various social media groups and organizations have been formed by these women, most notably Healing Breast Implant Illness and The Implant Truth Survivors.

Symptoms of this condition – which Dr Zuckerman explains, is a pattern of health problems likely caused by an autoimmune reaction to the implant – include mental confusion, joint pain, hair loss, dry eyes, chronic fatigue, and persistent flu-like symptoms. “In some cases,” she says, “silicone gel is leaking into their bodies and causing the autoimmune reaction. When the gel leaks into organs such as the lungs and liver, it can’t be removed surgically.”

In addition, a lot of women experience what is called capsular contracture. This occurs when the scar tissue around the implant (inside the body) gets tight and hard. This can make the breasts look abnormal and cause chronic pain and hardness.

Are there any forms of breast implants that are considered safe?

“There are no breast implants on the market that never cause side effects or complications,” says Dr Zuckerman. “In general, breast implants filled with saline are less likely to cause serious injury than those filled with silicone gel, but we know many women who have become ill because of saline implants.”

Often, when a woman chooses to undergo this procedure, she is persuaded by her plastic surgeon (or breast surgeons after mastectomy) that breast implants are safe devices. Although there are thousands of stories of women whose health deteriorated as a result of their implants, the voice a plastic surgeon will more than often outweigh the information. This is because patients tend to hear what they want instead of making a decision based on information from both sides.

“Then, when women experience these complications,” explains Dr Zuckerman, “they are furious at themselves for making a decision based on limited information and furious at their doctors for not warning them of the risks. The women who are most harmed by breast implants are the ones that don’t realize that their health is deteriorating because of their implants, or don’t have $8,000-10,000 to get their implants removed by an experienced explant surgeon.” […]

Read the original article here.

Pregnancy and Breastfeeding Concerns


When considering whether to have breast implant surgery, you should take your future plans for childbearing and breastfeeding into consideration.

Pregnancy

Although some researchers believe that having breast implants may harm a growing fetus, there is a lack of research to determine if this is true. Researchers who believe that implants can result in autoimmune issues or birth defects in children have several theories: 1) silicone molecules travel through the placenta from mother to baby, 2) mothers form antibodies from silicone exposure that transfer to their fetuses, and 3) autoimmune issues experienced by the mother are inherited by the baby.11

 However, there are not enough well-done studies to prove that any of these theories are true.

There are other reasons why women who are planning to get pregnant may want to avoid breast implants. Pregnancy can cause drastic changes in breast size and shape, so having implants may affect the shape of breasts after the baby is born. When breast implants are initially placed, the surgeon normally uses the natural shape of the breast as a guide. After pregnancy and breastfeeding, implants may no longer enhance the look of the breast in the way that they did before.

Breastfeeding

Breastfeeding has many health benefits for an infant, including immune strengthening, neurological development, and nutritional intake. Additionally, the skin-to-skin contact during feeding promotes bonding between a mother and child. Studies indicate that women with breast implants may find it difficult to produce enough milk due to pressure on the milk ducts from implants or damage to mammary glands or ducts during the implant surgery. For example, several studies show that women with implants were more likely to need to supplement their baby’s diet with formula, because they were unable to produce enough breast milk to feed their baby.12

 This information is important for any woman who plans to become pregnant in the future, and especially for women who previously had difficulty with breastfeeding.

Mothers with silicone implants have expressed concern that silicone could get into their breast milk. However, researchers are not certain whether silicone leaking out of an implant could be ingested by an infant during feeding.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Complications of Saline Breast Implants

Elizabeth Nagelin-Anderson, MA and Diana Zuckerman, PhD, National Center for Health Research

How risky are breast implants? This is a controversial question, but implant manufacturers have done research showing that local complications, including pain, rupture, and the need for additional surgery, are very common within the first three years.

The FDA required breast implant manufacturers Mentor Corporation and Inamed Aesthetics (formerly called McGhan) to conduct research on the complications of saline breast implants for breast reconstruction and breast augmentation patients. The purpose of this research was to provide women with information so that they can make a more informed decision about whether or not they want saline breast implants. This information is supposed to be made available by plastic surgeons to all patients before they make their decision. The studies did not include diseases or conditions such as cancer, lupus, or fibromyalgia.

This issue brief is based on the FDA’s analyses of data collected by Mentor Corporation and Inamed Aesthetics. It is based on research, not opinion. The 3-year data were analyzed by the FDA in 2000 and the 5-year data were analyzed in 2002. This fact sheet is only about reconstruction patients.

Mentor Saline Implants

Mentor conducted a 5-year study on reconstruction patients. Unfortunately, so many women (almost 60%) dropped out of the study before the five years were completed, that the information is not reliable. For that reason, we are only providing the information collected during the first 3 years after getting implants, which included 78% of the patients.

Important Points from the Mentor Data

  • Most women can expect at least one complication within the first 3 years.
  • 40% of reconstruction patients can expect to have additional surgery within the first 3 years.

Mentor Reconstruction Patients 3-Year Complication Rate

Reconstruction patients experienced the following problems within the first 3 years of receiving their implants:
Table of Reconstruction Patient Complications after Three Years
Only 78% of the reconstruction patients who originally enrolled in the study completed all 3 years. Women who had their implants removed, and women who left the study for any reason were not followed. Complications were measured up until a woman left the study, but percentages were based on the total number of women who started the study. So, the complication rate is actually even higher.

Inamed Saline Implants

Inamed, formerly called McGhan, conducted a 5-year study on breast reconstruction patients. They collected information at the 3-year point from 71% of the reconstruction patients who originally enrolled in the study.

At the 5-year point they collected information from 57% of the reconstruction patients. This is a problem, since no information is available for 43% of the patients. Women who had their implants removed, and women who left the study for any reason were not followed. Complications were measured up until a woman left the study, but percentages were based on the total number of women who started the study. So, the complication rate is actually even higher, and the 3-year data are more reliable than the 5-year data.

Important Points from the Inamed Data

  • Most women can expect to experience at least one complication at some point within 5 years after implant surgery.
  • 40% of reconstruction patients can expect to have additional surgery within the first 5 years.

Inamed Reconstruction Patients 3-Year and 5-Year Complication Rates

Reconstruction patients experienced the following complications during the first three years and first five years after surgery.
Complication Rates for Reconstruction Patients at 3 and 5 Years

*Loss of nipple sensation is not listed since nipples are removed during mastectomy.

Most complications for Inamed patients through the first 5 years are similar to those reported after the first 3 years. Since it is well known that some complications, such as rupture and capsular contracture, increase over time, women with complications were apparently more likely to leave the study than those who continued. Some of these women have left their plastic surgeons and could not be contacted.

References

Read the mentor educational brochure here

Read the Inamed publication on making an informed decision here

Read the FDA’s list of potential local complications here

Read the FDA’s warning about ALCL here

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

 

What to Ask Your Plastic Surgeon if You’re Considering Implants


When you’re considering breast implants, it is often hard to know what questions to ask and who to ask. For many plastic surgeons, breast augmentation is a large part of their practice and their salary. Keep in mind that you may not receive completely objective responses, but here’s a good place to start:

Before you go in, make sure the plastic surgeon is very experienced in breast augmentation. Any physicians or dentists may call themselves cosmetic surgeons even if they aren’t well trained in surgery. That’s perfectly legal, but their patients are taking a risk.

Ideally, you will want to see a plastic surgeon who is board certified in plastic surgery (not in some other medical specialty), because that will help assure you that they received the appropriate training to perform breast augmentation. You can find out if a doctor is board-certified by the American Board of Plastic Surgery online.

However, not all board certified plastic surgeons are skilled at implanting or removing breast implants. Check online for complaints about any plastic surgeons that you are considering. If there are serious complaints about patients who were harmed by the surgeon, look for a plastic surgeon with better ratings.

Once you decide to see a surgeon, here are some questions to ask during your appointment:

  • Ask about all your options for breast enhancement. Some women may be satisfied with the results from a breast lift alone, and may not need implants to achieve the look they desire. You can also ask your surgeon about a fat transfer as an alternative to implants.
  • Ask to see before and after photographs of your plastic surgeon’s patients. Some doctors use photographs of patients whose surgery was done by other surgeons. If the doctor says that the photos are of his/her patients, ask when those patients had surgery. If it was a long time ago, ask to see more recent photos.
  • Ask to see photographs of her or his patients that were taken at least three years after the surgery. Many patients look good immediately after surgical scars have healed but their breasts look different years later.
  • Ask your doctor for a patient booklet or other written information that includes the risks of breast implants and read that information at least one week before surgery so you have time to ask questions and gather more information.
  • Ask for a copy of the informed consent form at least one week before surgery.
  • Ask whether there is a warranty on the implants and, if so, what is and isn’t included.
  • Ask whether the doctor will remove your implants for free if you have serious problems. If so, will the surgical center services also be free? What if you want them removed, but the doctor doesn’t think it is necessary?

If you’re still unsure about getting breast implants, seek advice from someone that has gone through breast implant surgery at least 5 -10 years ago. They may be able to help you make the decision that is best for you. Click here to read some personal stories from women who had breast implants.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.