fda evidence 2.0.

I have poured through hours upon hours and hundreds of pages of data, information and research relating to breast implants. While the online support group was a contributor to my decision to remove my implants, it ultimately came down to the information that is provided by the FDA. The information is pretty eye opening, not to mention historically implants have actually been recalled because they weren't safe to begin with! I question there safety now given that they were approved without proof of safety and serious limitations they continue to acknowledge in current studies and knowing the ingredients that go into making implants that sit in our bodies! 

Here is a listing of some of the literature I've read through in no particular order. You should too if you have implants or are considering implants for any reason, whether it's for augmentation, reconstruction or due to mastectomy. It's important to note that SALINE implants are not entirely different than silicone because the shell is comprised of the same heavy metals that silicone implants are made of.

I've compiled a list of literature I have gone through and pulled quotes that I feel are significant (or at least they were for me) for understanding the full risk below each link. Please take the time to read the articles in their entirety to decide for yourself. Personally, I feel that the regulatory health and safety bodies pretty clearly state that they know toxins are in the implants but feel based on the acknowledged inadequate research that they are safe until new more thorough and accurate studies say otherwise and until such point as they have that they feel that women have enough information to make an informed decision regarding breast augmentation with implants......That means the onus is on YOU! Read through these and decide for yourself.

Breast Implant Information Provided by the FDA
(All direct links to the material quoted are the titles, just click to review the data in it's entire context)

MORE CONTENT TO COME SOON!

26.     Important Information for Augmentation Patients About Mentor MemoryGelTM Silicone Gel-Filled Breast Implants (November 2006)

Precautions

Safety and effectiveness have not been established in patients with the following:

• Autoimmune diseases (for example, lupus and scleroderma).

• A weakened immune system (for example, currently taking drugs that weaken the

body’s natural resistance to disease).

• Conditions that interfere with wound healing and blood clotting.

• Reduced blood supply to breast tissue.

• Radiation to the breast following implantation.

• Clinical diagnosis of depression or other mental health disorders, including body

dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders with your surgeon prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery.

1.4. Important Factors You Should Consider When Choosing Silicone Gel-Filled Implants.

Breast implants are not lifetime devices, and breast implantation is likely not a one-time surgery. You will likely need additional unplanned surgeries on your breasts because of complications or unacceptable cosmetic outcomes. These additional surgeries can include implant removal with or without replacement, or they can include other surgical procedures. When you have your implants replaced (revision-augmentation), your risk of future complications increases compared to first time (primary) augmentation surgery.

 

After undergoing breast augmentation surgery (either primary or revision), your health insurance premiums may increase, your insurance coverage may be dropped, and/or future coverage may be denied. Treatment of complications may not be covered as well. You should discuss the complete extent of your insurance coverage with your insurance company before undergoing surgery.

 

Rupture of a silicone gel-filled breast implant is most often silent. This means that neither you nor your surgeon will know that your implants have a rupture most of the time.

There are also consequences of rupture. If rupture occurs, silicone gel may either remain within the scar tissue capsule surrounding the implant (intracapsular rupture), move outside the capsule (extracapsular rupture), or gel may move beyond the breast (migrated gel). There is also a possibility that rupture may progress from intracapsular to extracapsular and beyond. There have also been health consequences reported in the literature.

 

There have been rare reports of gel movement to nearby tissues such as the chest wall, armpit, or upper abdominal wall, and to more distant locations down the arm or into the groin. This has led to nerve damage, granuloma formation  and/or breakdown of tissues in direct contact with the gel in a few cases. There have been reports of silicone presence in the liver of patients with silicone breast implants. Movement of silicone gel material to lymph nodes in the axilla also has been reported, even in women without evidence of rupture, leading to lymphadenopathy.

 

Concerns have been raised over whether ruptured implants are associated with the development of connective tissue or rheumatic diseases and/or symptoms such as fatigue and fibromylagia. A number of epidemiology studies have evaluated large populations of women with breast implants from a variety of manufacturers and implant models. These studies do not, taken together, support a significant association of breast implants with a typical, diagnosed rheumatic disease. Other than one small study,these studies do not distinguish whether the women had ruptured or intact implants.

(My note: notice the wording of this phrase? They do not tell us there is NO association, they just suggest is not "significantly" associated. What does that mean? The way this is written suggests the risk is low to the user, you and me, but also leaves the company free from litigation risk.....keep in mind most of the studies conducted around this were not designed to evaluate the risks of connective tissue disease and were based on short term studies (up to 4 years) and not over 5, 10, 15 or 20 years when many of these symptoms begin to present themselves)

 

Capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time. Capsular contracture occurs more commonly in revision-augmentation than in primary augmentation. Because you may have your initial implants replaced, you should be aware that your risk of capsular contracture increases with revision- augmentation. Capsular contracture is a risk factor for implant rupture, and it is the most common reason for reoperation.

 

In Mentor’s Core Study, for women receiving augmentation implants for the first time, the risk of severe capsular contracture was 8% through 3 years. This means that 8 out of every 100 women who received Mentor implants for primary breast augmentation had severe capsular contracture at least once during the first 3 years after receiving the implants.For women receiving revision-augmentation implants, the risk of severe capsular contracture was 19% through 3 years. This means that 19 out of every 100 women who received Mentor implants for breast revision-augmentation had severe capsular contracture at least once during the first 3 years after receiving the implants.

Additional surgery may be needed in cases where pain and/or firmness are severe. This surgery ranges from removal of the implant capsule tissue, to removal and possible replacement of the implant itself. This surgery may result in loss of your breast tissue. Capsular contracture may happen again after these additional surgeries. Capsular contracture may increase the risk of rupture.

 

Also, implant replacement increases your risks of future complications. For example, the risks of severe capsular contracture and reoperation increase for patients with implant replacement compared to first time placement. You should consider the possibility of having your implants replaced and its consequences when making your decision to have implants.

 

Lymphadenopathy

Lymphadenopathy is a chronic enlargement of the lymph nodes. A lymph node is a round mass of tissue which makes cells as part of your immune system. The lymph nodes in the armpit (axilla) drain the breast area of fluid. Sometimes the enlarged lymph nodes are painful. If they become too large or painful, the lymph node(s) may need to be surgically removed. Painful and/or enlarged lymph nodes should be reported to your doctor.

Literature reports associate lymphadenopathy with both intact and ruptured silicone breast implants. One study reported that armpit lymph nodes from women with both intact and ruptured silicone gel implants had abnormal tissue reactions, granulomas, and the presence of silicone.These reports were in women who had implants from a variety of manufacturers and implant models.

 

Connective Tissue Disease (CTD)

Connective tissue diseases include diseases such as lupus, scleroderma, and rheumatoid arthritis. Fibromyalgia is a disorder characterized by chronic pain in the muscles and soft tissues surrounding joints, with tenderness at specific sites in the body. It is often accompanied by fatigue. There have been a number of published epidemiological studies which have looked at whether having a breast implant is associated with having a typical or defined connective tissue disease. The study size needed to conclusively rule out a smaller risk of connective tissue disease among women with silicone gel-filled breast implants would need to be very large. The published studies taken together show that breast implants are not significantly associated with a risk of developing a typical or defined connective tissue disease. These studies do not distinguish between women with intact and ruptured implants. Only one study evaluated specific connective tissue disease diagnoses and symptoms in women with silent ruptured versus intact implants, but it was too small to rule out a small risk. 

My Note: once again notice the language used, "take together" (you should look at studies to see which are independent, often the smaller ones who lack the funding resources, and those with funding from the implant industry or companies, which are larger but have a conflict of interest because of the funding source being the implant companies)

 

CTD Signs and Symptoms

Literature reports have also been made associating silicone breast implants with various rheumatological signs and symptoms such as fatigue, exhaustion, joint pain and swelling, muscle pain and cramping, tingling, numbness, weakness, and skin rashes. Scientific expert panels and literature reports have found no evidence of a consistent pattern of signs and symptoms in women with silicone breast implants. Having these rheumatological signs and symptoms does not necessarily mean you have a connective tissue disease; however, you should be aware that you may experience these signs and symptoms after undergoing breast implantation. If you notice an increase in these signs or symptoms, you should consider seeing a rheumatologist to determine whether these signs or symptoms are due to a connective tissue disorder or autoimmune disease.

 

• Cancer

Breast Cancer – Reports in the medical literature indicate that patients with breast implants are not at a greater risk than those without breast implants for developing breast cancer. Some reports have suggested that breast implants may interfere with or delay breast cancer detection by mammography and/or biopsy; however, other reports in the published medical literature indicate that breast implants neither significantly delay breast cancer detection nor adversely affect cancer survival of women with breast implants.

 

Brain cancerOne recent study has reported an increased incidence of brain cancer in women with breast implants as compared to the general population. The incidence of brain cancer, however, was not significantly increased in women with breast implants when compared to women who had other plastic surgeries. Another recently published review of four large studies in women with cosmetic implants concluded that the evidence does not support an association between brain cancer and breast implants.

 

Respiratory/lung cancer One study has reported an increased incidence of respiratory/lung cancer in women with breast implants. Other studies of women in Sweden and Denmark have found that women who get breast implants are more likely to be current smokers than women who get breast reduction surgery or other types of cosmetic surgery. 

Cervical/vulvar cancer One study has reported an increased incidence of cervical/vulvar cancer in women with breast implants. The cause of this increase is unknown.

Other cancersOne study has reported an increased incidence of stomach cancer and leukemia in women with breast implants compared to the general population. This increase was not significant when compared to women who had other types of plastic surgeries.

 

Neurological Disease, Signs, and Symptoms

Some women with breast implants have complained of neurological symptoms (such as difficulties with vision, sensation, muscle strength, walking, balance, thinking or remembering things) or diseases (such as multiple sclerosis), which they believe are related to their implants. A scientific expert panel report found that the evidence for a neurological disease or syndrome caused by or associated with breast implants is insufficient or flawed. (My note: the studies currently available were not designed to evaluate this association, nor were they large enough, and many did not have controls - however that does not negate the possibility that there is a direct association to breast implants, it simply allows for plausible deniability that they are connected because there is no solid research that has truly been done to evaluate this to date)

• Suicide

In several studies, a higher incidence of suicide was observed in women with breast implants. There reason for the observed increase is unknown, but it was found that women with breast implants had higher rates of hospital admission due to psychiatric causes prior to surgery, as compared with women who had breast reduction or in the general population of Danish women. (My note: what about the psychiatric history of North American women? Why do they only specifically mention Danish women?)

• Effects on Children

At this time, it is not known if a small amount of silicone may pass through from the breast implant silicone shell into breast milk during breastfeeding. Although there are no current established methods for accurately detecting silicone levels in breast milk, a study measuring silicon (one component in silicone) levels did not indicate higher levels in breast milk from women with silicone gel-filled implants when compared to women without implants. In addition, concerns have been raised regarding potential damaging effects on children born to mothers with implants. Two studies in humans have found that the risk of birth defects overall is not increased in children born after breast implant surgery. Although low birth weight was reported in a third study, other factors (for example, lower pre-pregnancy weight) may explain this finding. This author recommended further research on infant health.

 

 

Potential Health Consequences of Gel Bleed

Small quantities of low molecular weight (LMW) silicone compounds, as well as platinum (in zero oxidation state), have been found to diffuse (“bleed”) through an INTACT implant shell.The evidence is mixed as to whether there are any clinical consequences associated with gel bleed. For instance, studies on implants implanted for a long duration have suggested that such bleed may be a contributing factor in the development of capsular contracture and lymphadenopathy. However, evidence against gel bleed being a significant contributing factor to capsular contracture and other local complications, is provided by the fact that there are similar or lower complication rates for silicone gel-filled breast implants than for saline-filled breast implants. Saline-filled breast implants do not contain silicone gel and, therefore, gel bleed is not an issue for those products. Furthermore, toxicology testing has indicated that the silicone material used in the Mentor implants does not cause toxic reactions when large amounts are administered to test animals. It also should be noted that studies reported in the literature have demonstrated that the low concentration of platinum contained in breast implants is in the zero oxidation (most biocompatible) state. In addition, two separate studies sponsored by Mentor have demonstrated that the low concentration of platinum contained in its breast implants is in the zero oxidation (most bio compatible) state. Mentor performed a laboratory test to analyze the silicones and platinum (used in the manufacturing process), which may bleed out of intact implants into the body. Over 99% of the LMW silicones and platinum stayed in the implant. The overall body of available evidence supports that the extremely low level of gel bleed is of no clinical consequence.

My Note: they use the saline implants as proof that the bleed is of no consequence, however, they fail to acknowledge that saline SHELLS are comprised of silicone and other heavy metals as well. They may not have gel inside of them but there shell is equally as harmful. Which is WHY this statement is concerning because it infers that they are somehow safe despite known bleed through an intact shell into your body. Also the test animals that showed no toxicological response? Those were conduced over periods of less than 90 days...... not 5, 10 or 15 years..... Plus the studies used to suggest safety are conduction and funded by Mentor itself.... conflict of interest.

Mentor’s Core Study results indicate that the risk of at least one occurrence of any complication (including reoperation) at some point through 3 years after implant surgery is 37% for primary augmentation patients and 50% for revision-augmentation patients.

 

In Mentor’s Core Study, there were 176 additional surgical procedures performed in 109 reoperations involving 83 primary augmentation patients. The most common reason for reoperation through 3 years in primary augmentation patients was because of capsular contracture (40 of 109 reoperations).

 

In Mentor’s Core Study, there were 105 additional surgical procedures performed in 58 reoperations involving 39 revision-augmentation patients. The most common reason for reoperation in revision-augmentation patients through 3 years was capsular contracture (23 of 58 reoperations).

 

3.7. What Were Other Clinical Data Findings in Augmentation Patients?

CTD Diagnoses

Three primary augmentation patients and one revision-augmentation patient in the Mentor Core Study were reported to have a new diagnosis of CTD according to a rheumatologist. These diagnoses were Hashimoto’s Thyroiditis at 2 years, two cases of rheumatoid arthritis at 2 and 3 years, and hypothyroidism at 2 years. It cannot be concluded that these CTD diagnoses were caused by the implants because there was no comparison group of similar women without implants.

 

CTD Signs and Symptoms

Data on over 100 self-reported signs and symptoms, including about 50 self-reported rheumatological symptoms, were collected. Compared to before having the implants, significant increases were found for fatigue, exhaustion, joint swelling, joint pain, numbness of hands, frequent muscle cramps, and the combined categories of fatigue, pain, and fibromyalgia-like symptoms in primary augmentation patients, and for joint pain in revision-augmentation patients. These increases were not found to be related to simply getting older over time. The Mentor Core Study was not designed to evaluate cause and effect associations because there is no comparison group of women without implants, and because other contributing factors, such as medications and lifestyle/exercise, were not studied. Therefore, it cannot be determined whether these increases were due to the implants or not, based on the Mentor Core Study. However, you should be aware that you may experience an increase in these symptoms after receiving breast implants.

My note: so one breath they say there were significant increases in these symptoms and blame it on "age" but then in the same paragraph they suggest that the study wasn't designed to evaluate cause and effect and that they cannot determine whether increases were due to implant or not.... Let that sink in.

26.    Mentor Saline Filled & Spectrum Breast Implants

27.    INAMED Making An Informed Decision Saline-Filled Breast Implant Surgery (2004)

  • Whether you are undergoing augmentation or reconstruction, be aware that breast implantation may not be a one time surgery. You are likely to need additional surgery and surgeon visits over the course of your life.

  • Breast implants are not considered lifetime devices. You will likely undergo implant removal with or without replacement over the course of your life.

  • Many of the changes to your breast following implantation are irreversible (cannot be undone). If you later choose to have your implant(s) removed, you may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast.

  • Breast implants may affect your ability to produce milk for breast feeding. Also, breast implants will not prevent your breast from sagging after pregnancy.

  • With breast implants, routine screening mammography will be more difficult, and you will need to have additional views, which means more time and radiation.

  • For patients who have undergone breast implantation either as a cosmetic or a reconstructive procedure, health insurance premiums may increase, coverage may be dropped, and/or future coverage may be denied. Treatment of complications may not be covered as well. You should check with your insurance company regarding these coverage issues. 

Long Term Effects

The long term safety and effectiveness of breast implants have not been studied; however, INAMED is monitoring the long term (10 year) chance of implant rupture, reoperation, implant removal, and capsular contracture (hardening of the tissues around the implant). INAMED is also conducting mechanical testing to assess the long-term likelihood of implant rupture. As new information becomes available, INAMED will issue an updated version of this brochure. 

My note: what about studying the incidence of CTD and other reported health problems??

Capsulotomy

You should be aware that closed capsulotomy, the practice of forcible squeezing or pressing on the fibrous capsule around the implant to break the scar capsule is not recommended as this may result in breakage of the implant. 

Additional Surgeries

You should should know that there is a high chance that you will need to have additional surgery at some point to replace or remove the implant. Also, problems such as deflation, capsular contracture, infection, shifting, and calcium deposits can require removal of the implants. Many women decide to have the implants replaced, but some women do not. If you choose not to, you may have cosmetically unacceptable dimpling and/or puckering of the breast following removal of the implant. 

Breast Feeding

At this time it is not known if a small amount of silicone may diffuse (pass through) from the saline-filled breast implant silicone shell and may find its way into breast milk. If this occurs, it is not known what effect it may have on the nursing infant. Although there are no current methods for detecting silicone levels in breast milk, a study measuring silicon (one component in silicone) levels did not indicate higher levels in breast milk from women with silicone–filled gel implants when compared to women without implants. 

With respect to the ability to successfully breast feed after breast implantation, one study reported up to 64% of women with implants who were unable to breast feed compared to 7% without implants. The periareolar incision site may significantly reduce the ability to successfully breast feed. 

Second Generation Effects

There have been concerns raised regarding potential damaging effects on children born of mothers with implants. A review of the published literature on this issue suggests that the information is insufficient to draw definitive conclusions. 

Inamed’s studies indicate, for example, that most women can expect to experience at least one complication at some point through 5 years after implant surgery. The studies also indicate that the chance of additional surgery through 7 years is 3 in 10 for augmentation patients and about 1 in 2 for reconstruction patients

DESCRIPTION OF STUDIES

INAMED conducted clinical studies testing of its saline-filled breast implants to determine the short-term and most common complications as well as benefits of their implants. These were assessed in the following studies:

  • The Large Simple Trial (LST)

  • The 1995 Augmentation Study (A95)

  • The 1995 Reconstruction Study (R95)

  • The Post Approval Survey Study (PASS)

 

The Large Simple Trial was designed to determine the 1-year rates of capsular contracture, infection, implant leakage/deflation, and implant replacement/removal. There were 2,333 patients enrolled for augmentation, 225 for reconstruction, and 317 for revision (replacement of existing implants). Of these enrolled patients, 62% returned for their 1-year follow-up visit.

 

The A95 and R95 Studies were designed as 5-year studies to assess all complications as well as patient satisfaction, body image, body esteem, and self concept. Patients were followed annually and data through 3 years (with partial 4 year data) were presented to FDA for PMA approval. After PMA approval, INAMED transitioned data collection to a post-approval study. The first phase of this postapproval study consisted of completion of the A95 and R95 Studies, with collection of all risk/benefit information through 5 years.

The A95/R95 sections of the brochure include original data presented to FDA for PMA approval along with the 5-year post-approval study data. The data presented through 5 years includes earlier data shown in the tables with new information added to it.

The Post Approval Survey Study was designed to collect long-term safety data from A95/R95 patients from 6-10 years post-implant. The data are collected from surveys that are mailed out to the patients each year. The PASS Study data are shown within both the Reconstruction and Augmentation Sections following the A95/R95 data. The data presented through 7 years includes earlier data shown in the tables with new information added to it. 

1-Year Complication Rate* 

Complication & Rate / Augmentation / Reconstruction / Revision

Capsular Contracture III/IV  /  7% / 13% / 12%

Implant Removal  / 6% / 14% / 8% /

Leakage/Deflation   / 4% / 3% / 5% /

Infection   / 2% / 6% / 3%

*Data on 62% of the 2875 patients enrolled in the study 

 

AUGMENTATION: WHAT WERE THE BREAST DISEASE AND CTD EVENTS?

 

Breast disease and connective tissue disease (CTD) were reported in some patients through 5 years after implantation in the A95 Study. Although there were 901 patients enrolled in the A95 Study, not every patient returned for each follow-up visit. Therefore, the percentage of patients with these events cannot be determined. Only the number of events can be reported. Without a comparison group of women with similar characteristics (such as age, race, etc.) and without breast implants, no conclusions can be made about the relationship between breast implants and these breast disease and CTD events.

 

There were 81 reports of breast disease through 5 years. Of these 81 reports, 7 are new since year 4. Additionally, 2 unknown outcome reports at year 4 were found to be false reports and were removed from the year 5 numbers, and the remaining 7 unknown outcome patients at year 4 were recategorized into benign. 

Confirmed reports were based on a diagnosis by a doctor. Unconfirmed reports were based on self-reports by the patients. There were 20 reports of CTD through 5 years. Of the 20 reports, 11 are new since year 4 (2 confirmed, 9 unconfirmed). Additionally, 3 unconfirmed reports at year 4 were found to be false reports and were removed from the year 5 numbers. 

The most common complication experienced through 7 years was reoperation (30%, 30 out of every 100 patients).

 

7 year Complication Rate

- Reoperation 30%

- Breast Pain  25%

 

- Capsular Contracture 16%

 

- Implant Removal 15%

 

 

- Implant Deflation 10%

 

** Reconstruction complication rates are even higher. See original document!

RECONSTRUCTION: WHAT WERE THE BREAST DISEASE AND CTD EVENTS?

 

Breast disease and connective tissue disease (CTD) were reported in some patients through 5 years after implantation in the R95 Study. Although there were 237 patients enrolled in the R95 Study, not every patient returned for each follow-up visit. Therefore, the percentage of patients with these events cannot be determined. Only the number of events can be reported. Without a comparison group of women with similar characteristics (such as age, race, etc.) and without breast implants, no conclusions can be made about the relationship between breast implants and these breast disease and CTD events.

There were 99 reports of breast disease through 5 years. Of these 99 reports, 7 are new since year 4. Additionally, 1 unknown outcome report was recategorized at 5 years. 

7-Year Complication Rate

 

N=237 Recontruction Patients 

- Reoperation - 49%

- Capsular Contracture - 43%

- Implant Removal - 31%

- Breast Pain - 26%

- Implant Deflation - 12%

Breast implant surveillance reports to the U.S. Food and Drug Administration: maternal-child health problems.

 

It is unknown whether exposure to biomaterials in breast implants may have teratogenic effects or leach into breast milk causing postnatalproblems.

46% described actual problems with breastfeeding or expressed concern that implants would be unsafe or interfere with breastfeeding.

 

44% described either nonspecific or specific signs, symptoms, or illnesses in children.

 

An additional 3.5% of reports (n=12) detailed a congenital anomaly believed by the reporter to be caused by breast implants.

WORKING ON MORE CONTENT TO COME SOON!!!!

 
 
 

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