fda evidence.

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)

A.      Silicone Gel Bleed Testing

1.      FDA Backgrounder on Platinum in Silicone Breast Implants

"However, the IOM report states that, Platinum is present in small amounts in implants… Reports that this platinum is in the form of platinate (Lykissa, et al., 1997) are unconfirmed.”

"Some studies have shown that small quantities of platinum may bleed through an intact implant shell and be present in trace amounts (parts per billion) in surrounding tissue. However, these results need to be confirmed using a larger number of subjects. Other studies have serious scientific flaws that raise concerns about the validity of their results and conclusions. Even if the analytical results of large, well controlled studies were to show relatively high levels of platinum in biological samples, the toxicological significance would still need to be determined.

 

Based on the existing literature, FDA believes that the platinum contained in breast implants is in the zero oxidation state, which would pose the lowest risk, and thus that the small amounts of platinum that leak through the shell do not represent a significant risk to women with silicone breast implants. FDA will continue to review and analyze the literature on the issue of platinum in breast implants, as part of its ongoing assessment of the safety of these devices.

2.     Silicone Gel-Filled Implants

"Breast implants are not lifetime devices. The longer a woman has implants, the more likely it is that she will need to have surgery to remove or replace them.

Women with breast implants may have a very low but increased likelihood of being diagnosed with anaplastic large cell lymphoma (ALCL).

There is no apparent association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. However, in order to definitively rule out these and other rare complications, studies would need to be much larger and longer than those conducted so far.

3.     2011 FDA Update on the Safety of Silicone Gel-Filled Breast Implants 

In the early 1980s, concerns arose about the safety of breast implants, in particular silicone gel- filled breast implants. FDA’s new surveillance systems identified frequent local complications and adverse outcomes, and other published case reports described cancer and connective tissue disease in some women with breast implants. In response, the FDA reclassified breast implant into Class III, higher-risk products needing premarket approval (PMA), and called for manufacturers to provide data demonstrating the devices were safe and effective.

In 1992, the FDA determined that the manufacturers had not adequately addressed public concerns about certain complications, such as implant rupture and silicone leakage. Following the advice of an outside expert advisory panel, the FDA removed all silicone gel-filled breast implants from the market and required manufacturers to submit premarket approval applications that contained data on safety and effectiveness. 

In order to meet a public health need, the FDA allowed manufacturers to provide silicone gel- filled implants for reconstruction after mastectomy, correction of congenital deformities, or replacement of existing implants. Manufacturers enrolled women who received silicone gel- filled breast implants for these purposes in Adjunct Studies so that data could be collected about device performance and safety. 

In November 2006, the FDA approved Allergan’s∗ Natrelle Silicone Gel-Filled Breast Implants and Mentor’s MemoryGel Silicone Gel-Filled Breast Implants. The FDA based its approvals on the manufacturers’ clinical studies, called Core Studies, which followed hundreds of women with silicone gel-filled breast implants for 3 (Mentor) or 4 (Allergan) years. Despite frequent local complications and adverse outcomes, the FDA determined that the benefits and risks of breast implants were sufficiently well understood for women to make informed decisions about their use. 

When the FDA approved silicone gel-filled breast implants in the U.S. in 2006, it recognized that there were limited data on rare events and long-term outcomes. In order to better understand the long-term performance of these devices and to monitor for previously unrecognized adverse events, the FDA required the manufacturers to conduct post-approval studies, analyzed silicone gel-filled breast implant Medical Device Reports (MDR) submitted to FDA, performed periodic literature reviews, and evaluated correspondence from researchers, health care providers, patients, and concerned citizens. 

As conditions of approval, the FDA required each manufacturer of silicone gel-filled breast implants to conduct six post-approval studies to characterize the long-term performance and safety of the devices. The FDA believes that data from these long-term, post-approval studies will provide important information for women, their families and friends, and health care providers, and may lead to improvements in implant design and labeling.

Due to the length of the studies required by the FDA, they have not all been completed. Rather than waiting for all studies to be completed, FDA believes it is important to share currently available information so that women may make informed decisions about their health care. 

Limitations in the post-approval studies to date preclude (prevent from happening) the detection of very rare rates of complications. However, post-approval studies to date do not show evidence that silicone gel-filled breast implants cause connective tissue disease or reproductive problems. ​Differences in study design, clinical endpoints and definitions, and patient populations preclude direct comparisons of the post-approval study results for the two approved silicone gel-filled breast implants. Patient follow-up rates are lower than anticipated, limiting the ability to draw definitive conclusions and to detect rare complications. 

Each manufacturer developed its own scientifically sound study design and statistical analyses. As a result, there are important differences between the two studies, including variations in number of study participants, patient enrollment criteria, clinical endpoints and definitions. These differences preclude direct comparisons of the two approved silicone gel-filled breast implants. In some cases, low patient follow-up rates may limit interpretation of the data.

Allergan Core Study

​​​

  1. The Allergan Core Study enrolled 715 patients 

  2. Based on the 2010 annual reports, the preliminary follow-up rates at 10 years post-implant are 66 percent for Allergan. Each study had some patients who were not available for follow-up because they had died or discontinued participation

  3. In the Allergan Core Study, the majority of ruptures were accompanied by symptoms; depending on the cohort, up to 35 percent of ruptures may be silent.

  4. Among the Allergan Core Study participants, over 10 years of follow-up, there have been nine diagnoses of CTD. These include four cases of rheumatoid arthritis, three cases of fibromyalgia, one case of Raynaud’s Syndrome, and one case of undifferentiated CTD. 

  5. Allergan reported 434 reoperations on 285 patients over 10 years 

Mentor Core Study

​​

  • Mentor Core Study enrolled 1,008 patients 

  • The preliminary follow-up rates at 8 years post-implant are 58 percent for Mentor 

  • There have been 28 confirmed diagnoses of connective tissue, autoimmune, or rheumatic disease in 21 patients. These include seven reports of fibromyalgia, six cases of rheumatoid or inflammatory arthritis, three cases of chronic fatigue syndrome, three cases of thyroid-related disease, one case of systemic lupus erythematosis, and eight other miscellaneous and unspecified CTD cases. 

  • Mentor reported 385 re-operations on 276 patients over 8 years post-implant 

The long-term follow-up of participants in the Core Studies demonstrates that a significant percentage of women who receive silicone gel-filled breast implants experience complications and adverse outcomes. The most frequently observed complications and adverse outcomes include capsular contracture, reoperation, removal of the implant, and implant rupture. The cumulative incidence of these complications increases over time – the longer a woman has breast implants, the more likely she is to experience a complication.

 

These studies did not demonstrate an association of silicone gel-filled breast implants with CTD, reproductive or lactation problems, or breast cancer. However, it is important to note that these studies were not designed to estimate the incidence of rare disease outcomes, nor were they designed to compare silicone gel-filled breast implants to alternative therapies. 

​​

  • The number of events that are reported to the FDA is often much lower than the number of events that actually occur. 

  • The size of the population exposed to the device (denominator) is often not known, so it is difficult to determine adverse event rates and put the number of adverse events in perspective to interpret the data.

  • It is difficult to know whether or not the implant caused or contributed to the adverse event based solely on information provided in a report. Establishing a cause and effect relationship is especially difficult if the device is not examined or if the analysis was inadequate. 

  • The current body of literature does not support an association between CTD and silicone gel-filled breast implants, but most of the available studies have limitations. 

  • Women with breast implants may be more likely to be diagnosed with anaplastic large cell lymphoma (ALCL) - cancer

  • Most studies have not found an association between connective tissue diseases as a group and silicone gel-filled breast implants. The FDA collaborated on one study in 2001 that found a positive association between extracapsular silicone gel-filled breast implants and fibromyalgia, but significant study design and patient selection weaknesses undermine the study’s conclusions.

  • Most studies that have examined specific connective tissue diseases like fibromyalgia, scleroderma and systemic lupus erythematosus have failed to identify an association, although the studies have recognized limitations, such as lack of very long-term duration of follow-up. (this is important because the FDA says the longer we have implants in the more likely we are to experience complications or adverse events).

  • Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use.

TABLE 18. PSR reports of device problems 

  • Device-patient incompatibility, 4860 events reported, 39.4%

  • Rupture, 4541 events reports, 36.8%

4.    Breast Augmentation with NATRELLE® Silicone-Filled Breast Implants (2009)

In Allergan’s Core Study, numerous signs and symptoms were collected at 2, 4, and 6 years post-implant. For primary augmentation patients at 6 years after implantation, statistically significant increases were found for the symptom category of Joint (includes joint pain, stiff in morning, swelling in other joints, and swelling of hands), Muscular (includes back pain, muscle pain, aches, or cramps, muscle weakness, neck pain, paralysis of arms or legs), Gastrointestinal (includes constipation, diarrhea, gastrointestinal pain, heartburn, loss of appetite, stomach pain or cramps, and vomiting), Neurological (includes headaches, loss of balance, numbness/tingle of arms or legs, problems with memory, problems with thinking, and ringing in ears), Urinary (includes problems with urination and urinating too often).and Fibromyalgia (includes back pain, fatigue, neck pain, pain, and pain in the chest). No significant increases were found in the categories of General, Global, Pain, Skin, Fatigue, and Other symptoms. For revision-augmentation patients at 6 years after implantation, no statistically significant increases were found in any of the symptom categories.

 

The 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 this increase was due to the implants or not, based on the Core Study. However, you should be aware that you may experience an increase in these symptoms after receiving breast implants. 

5.     Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) (Updated as of Feb 2017)

Since 2011, we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.

  • Regulatory bodies outside the United States issued communications on BIA-ALCL.  

    • The Australian Therapeutic Goods Administration (TGA) reported a detailed analysis of the 46 confirmed cases of BIA-ALCL in Australia, including 3 deaths. TGA estimated the risk of developing BIA-ALCL to be between 1-in-1000 and 1-in-10,000 women with breast implants.

As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including nine deaths. There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants. Most of the reports contained no information about the surface textures of any previous implants. In addition, 312 of the 359 reports included information on implant fill types. Of these, 186 reported implants filled with silicone gel and 126 reported implants filled with saline.

 

It is important to note that details on breast implant surface and fill type are limited. While the MDR system is a valuable source of information, it may contain incomplete, inaccurate, untimely, unverified, or biased data. Over time, we may gather more information about a report and thus the numbers listed above may change. In addition, the incidence or prevalence of an event cannot be determined from the MDR reporting system due to potential under-reporting, duplicate reporting of events, and the lack of information about the total number of breast implants.

6.     Risks of Breast Implants

Additional Surgeries

Breast implants are not lifetime devices. The longer you have breast implants, the more likely it is that complications will occur and you will need to have them removed. There is no guarantee that you will have a satisfactory cosmetic outcome from any reoperation.

 

Rupture 

Silicone gel is thicker than saline, so when a silicone gel-filled implant ruptures, the gel may remain in the shell or in the scar tissue that forms around the implant (intracapsular rupture). The longer you have a breast implant, the greater the chance of implant rupture.

 

The FDA recommends removing both saline-filled and silicone gel-filled breast implants if they have ruptured. You and your doctor will need to decide whether or not your implant has ruptured and if you should have it replaced or removed without replacement.

Rupture in Silicone Gel-Filled Implants

If your silicone gel-filled breast implant ruptures, it is not likely that you or your doctor will immediately notice. Silicone gel is thicker than saline, so when a silicone gel-filled implant ruptures, the gel may remain in the shell or in the scar tissue that forms around the implant (intracapsular rupture).

When a silicone gel-filled implant ruptures, a woman may notice a decrease in breast size, change in breast implant shape, hard lumps over the implant or chest area, an uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning, or changes in sensation. Ruptures that show symptoms usually happen outside of the capsule. However, some ruptures are called “silent ruptures.”

A “silent rupture” doesn’t change the way an implant looks or feels to a woman because the rupture occurs within the capsule. Silent ruptures are not usually evident by a physical examination by a doctor. Magnetic resonance imaging (MRI) is the most effective method for detecting silent rupture of silicone gel-filled breast implants. The FDA recommends MRI at 3 years after implantation and every 2 years after that to screen for rupture.

Silicone gel that leaks outside the capsule surrounding the implant may travel (migrate) away from the breast. The leaked silicone gel may cause lumps to form in the breast or in other tissue, most often the chest wall, armpit or arm. It may be difficult or impossible to remove silicone gel that has traveled to other parts of the body.

Connective Tissue Disease

The FDA has not detected any association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. In order to rule out these and other rare complications, studies would need to be larger and longer than these conducted so far.

7. Breast Augmentation with Natrelle Silicone-Filled Breast 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. Some patients with breast implants report having enlarged lymph nodes in the armpit(s). 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. 

What Are Other Reported Conditions?

There have been reports in the literature of other conditions in women with silicone gel- filled breast implants. Many of these conditions have been studied to evaluate their potential association with breast implants. Although no cause-and-effect relationship has been established between breast implants and the conditions listed below, you should be aware of these reports. Furthermore, there is the possibility of risks, yet unknown, which in the future could be determined to be associated with breast implants. 

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 published studies overall show that breast implants are not significantly associated with a risk of developing a typical or defined connective tissue disease. However, the study size needed to conclusively rule out a small risk of connective tissue disease among women with silicone gel-filled implants would need to be very large. 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 the study was too small to rule out a small risk.

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. 

Brain cancer – One 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 of 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 cancers One 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. 

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 (PERSONAL NOTE: Saline implant shells are made of the same heavy metals as silicone!!!!! - Please see below links of SSED for this data). 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 Allergan’s implants does not cause toxic reactions when large amounts are administered to test animals. It should also 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.Allergan 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: The animal testing was conducted over 30-90 day periods, not years or decades as many women have their implants in their bodies for)

Allergan’s Core Study results indicate that the risk of at least one occurrence of any complication (including reoperation) at some point through 7 years after implant surgery is 45% for primary augmentation patients and 57% for revision-augmentation patients.  (My note: that is nearly half of every primary augmentation patients and almost 2/3 of revision!!!!!)

Quality of Life Assessments: Quality of life assessments were obtained prior to implantation and at 1, 2, 4, and 6 years post-surgery. The 6-year data is provided here. For primary augmentation patients, the SF-36, which is a collection of scales that measure mental and physical health, showed an improvement in one scale and a worsening in six scales after 6 years compared to before breast implantation,  

The most common reason for implant removal was capsular contracture (35 of the 107 implants removed). 

8.     Directions for Use: Natrelle Silicone Filled Breast Implants

8.     A) Guidance for Industry and FDA Staff Saline, Silicone Gel, and Alternative Breast Implants

4.4 Volatiles

We recommend you analyze the elastomer shell for volatile components using a headspace detector.

 

4.5 Heavy Metals

We recommend you provide qualitative and quantitative analyses for heavy metals on the final finished shell. The heavy metal analyses should include, but need not be limited to, analyses of the following metals: platinum (Pt); tin (Sn); zinc (Zn); chromium (Cr); arsenic (As); lead (Pb); antimony (Sb); nickel (Ni); and copper (Cu). In addition, for the metal used as the catalyst in the curing reaction, we recommend you provide the valence state and the amount of residue of the catalyst. In lieu of providing a complete heavy metal analysis on the finished shell, you may provide the purity of the catalyst (with trace elements) used in the raw shell material, along with an analysis of the finished shell for just the catalyst metal used.

WANT TO KNOW WHAT IS IN YOUR IMPLANTS? 

View the SSED (Summary of Safety & Effectiveness Data) documents below (pages 5-8 usually list the ingredients)

9.     SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) ​- Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants 

  1. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH

    Below is a list of the potential adverse effects (e.g., complications) associated with the use of the device.

  •  Reoperation (additional surgeries)

  •  Implant Removal with or without Replacement

  •  Implant Rupture

  •  Capsular Contracture

  •  Swelling

  •  Implant Malposition or Displacement

  •  Breast Pain

  •  Ptosis

  •  Infection including toxic shock syndrome

  •  Breast/Skin Sensation Changes

  •  Nipple Complications

  •  Seroma/Fluid Accumulation

  •  Delayed Wound Healing

  •  Hematoma

  •  Hypertrophic Scarring

  •  Asymmetry

  •  Redness

  •  Wrinkling/Rippling

  •  Skin Rash

  •  Bruising

  •  Extrusion of Implant

  •  Implant Palpability/Visibility

  •  Gel Fracture

  •  Irritation

  •  Tissue/Skin Necrosis

  •  Upper Pole Fullness

  •  Capsule Calcification

  •  Lymphadenopathy

  •  Lymphedema

  •  Palpable Orientation mark

  •  Pneumothorax

  •  Scarring

  •  Breastfeeding difficulties

  •  Calcium deposits

  •  Breast tissue atrophy/chest wall deformity

  •  Connective Tissue Disease (CTD)

  •  CTD signs and symptoms

  •  Neurological Disease

  •  Neurological Signs and Symptoms

  •  Cancer

  •  Lymphoma

  •  Suicide

  •  Potential Effects on Offspring 

Gel Materials

3. Volatiles

Analysis for volatiles present in the shell and patch material showed that the maximum exposure possible from implant residuals for isopropyl alcohol to be 201.1 μg and for xylene to be 337.2 μg. Analysis for volatiles present in gel was not necessary because the gel materials do not contain any organic solvents. The volatiles testing results are comparable to results seen in previously approved breast implant devices. 

  1. To independently assess the potential for distribution of silicone post-implantation, a pharmacokinetics study of the silicone gel used in Allergan’s Silicone-Filled Breast Implants was performed. The study design consisted of 3 Fischer F-344 female rats that were subcutaneously implanted with approximately 3.4 grams of C14 radiolabeled silicone gel for 30 days. After dosing, the rats were housed in individual glass metabolism chambers, which allowed separate collection of carbon dioxide, potential expired volatile chemicals, feces and urine. Blood was drawn throughout the study period. Low amounts of the radiolabel were collected in blood (0.0190% of dose), or were measured cumulatively in expired air (0.0004% of dose), feces (0.0186% of dose) and urine (0.0005% of dose). In regard to individual tissues, the liver, muscle and skin had the highest counts (0.0122%, 0.0055% and 0.0020% of the implanted dose, respectively). The vast majority of the gel remained at the implantation site (~100% of dose), thus demonstrating that the gel was encapsulated, with minimal movement away from the site of implantation. The data are similar to the observations reported in the published scientific literature. The results are comparable to results seen in previously approved breast implant devices

10.    SUMMARY OF SAFETY AND EFFECTIVENESS DATA (Inamed® (Allergan) Silicone-Filled Breast Implants)

Silicone gel was evaluated in a 6-week subchronic toxicity study in female Fischer 344 rats that primarily focused upon the histology of the implantation sites. 

11.     SUMMARY OF SAFETY AND EFFECTIVENESS DATA  (Mentor MemoryGelTM Silicone Gel- Filled Breast Implants)

Volatiles, Semi-volatiles and Heavy metals listed on pages 2 -8

12.     SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) (Mentor MemoryShapeTM Breast Implants)

13.     SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) (Sientra Silicone Gel Breast Implants)

** Take a look at pages 8-11 and the biocompatibility testing, you will note that the intervals they used to suggest exposure is safe are days to several month in time, not years or decades.

14.     SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED (Mentor Saline Breast Implants)

15.     SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED Allergan (formerly called McGhan and Inamed) Medical RTV Saline-Filled Breast Implants

World Health Organization Fact Sheets

Lead poisoning & exposures

Arsenic

 

Mercury & health

Cadmium

 

 

Read about the  Heavy Metals data and risks (the ones found inside saline/silicone implants)

16.    Labeling for Approved Breast Implants (FDA)

17.    Guidance for Industry and FDA Staff - Saline, Silicone Gel, and Alternative Breast Implants

18.    Ideal Implant Saline-filled Breast Implant Patient Labelling

19.    Ideal Implant Saline-filled Summary of Safety & Effectiveness

       

20.     Allergan (formerly called McGhan and Inamed) Saline-Filled Breast Implant Patient Labelling

22.    Allergan Saline-Filled Breast Implant Summary of Safety & Effectiveness

23.    Mentor Saline-Filled and Spectrum Breast Implants Patient Labelling

24.    Mentor Saline-Filled and Spectrum Breast Implants Summary of Safety & Effectiveness

25.    Post Approval Study - Data 2015- This PAS can be searched for other studies related to implants. The data in this specific study is not ideal because of the high volume of women that were lost track of in the study. Also their "control group" is outlined as the women who had saline implants as opposed to women who never had implants to begin with. Given that saline filled shells are comprised of silicone and heavy metals this is not an ideal control group to determine more severe risks.

 
 
 

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