FDA Evidence

Continued.

26.   MENTOR MEMORYGEL ® SILICONE GEL-FILLED BREAST IMPLANTS  Data Sheet

•     Rupture – Rupture of a silicone gel-filled br east implant is most often silent (i.e., there are no symptoms experienced by the patient and no physical sign of changes with the implant) rather than symptomatic. The sensitivity of plastic surgeons familiar with implants to diagnose rupture is 30% compared to 89% for MRI.

Therefore, you should advise your patient that she will need to have regular MRIs over her lifetime to screen for silent rupture even if she is having no problems. The first MRI should be performed at 3 years postoperativel y, then every 2 years thereafter. Additional MRIs should be performed when you or other physicians deem necessary. The importance of these MRI evaluations should be emphasized. If rupture is noted on MRI, then you should advise your patient to have her implant removed.  

Explantation – Implants are not considered lifetime devices, and patients likely will undergo implant removal(s), with or without replacement, over the course of their life. When implants are explanted without replacement, changes to the patient’s breasts may be irreversible. Complication rates are higher following revision surgery (removal with replacement).  

ReoperationAdditional surgeries to the patients’ breasts and/or implants will likely be required, either because of rupture, other complications, or unacceptable cosmetic outcomes. Patients should be advised that their risk of future complications increases with revision surgery as compared to primary augmentation or reconstruction surgery.   

• ADVERSE EVENTS

 

Rupture - Breast implants are not lifetime devices. Breast implants rupture when the shell develops a tear or hole. Rupture can occur at any time after implantation, but they are more likely to occur the longer the implant is implanted.  

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. See below for details.  

Mentor’s Core Study included rupture rate data from the non-MRI cohort at years 1, 2, and 3 and from the MRI cohort at years 1 and 2. All reported ruptures were from patients in the MRI cohort. The rupture rates were 0.5% for primary augmentation, 7.7% for revision-augmentation, 0.9% for primary reconstruction, and 0% for revision -reconstruction. There were 8 ruptured/suspected ruptured implants in 6 patients through 3 years. Only 2 of the implants were explanted and confirme d to be ruptured; the other implants remain as suspected rupture based on MRI evaluation. Of these 8 implants, 4 showed intracapsular gel and 4 showed extracapsular gel on MRI (3 implants with extracapsular gel were in 2 revision-augmentation patients and 1 was in a primary reconstruction patients) . For one of these implants with extracapsular gel, this was a confirmed case in which the device was explanted and the intracapsular gel rupture progressed into an extracapsular gel rupture as shown by MRIs at approximately 10 months and approximately 2 years. There were no cases of migrated gel.      (Important to note this data is only for the first 3 years, it is not looking at the data longer term, when we know the rupture rates increase dramatically)

Below is a summary of information related to the health consequences of implant rupture, which have not been fully established. These reports were in women who had implants from a variety of manufacturers and implant models.

•    Local breast complications reported in the published literature that were associated with rupture include breast hardness, a change in breast shape or size, and breast pain.These symptoms are not specific to rupture, as they also are experienced by women who have capsular contracture.

 

•    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 s ilicone 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, as discussed below.

 

 

•     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 fibromyalgia. 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 an association of breast implants and a diagnosed rheumatic disease. Other than one small study, these studies do not distinguish whether the women had ruptured or intact implants.

 

•     Capsular Contracture - The scar tissue (capsule) that normally forms around the implant may tighten over time and compress the implant, making it feel firm and leading to what is called capsular contracture. Capsul ar 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 patients undergoing revision surgery than in patients undergoing primary implantation surgery. Capsular contracture is a risk factor for implant rupture, and it is the most common reason for reoperation in augmentation and reconstruction patients.

 

 

In Mentor’s Core Study, the risk of capsular contracture Grade III/IV through 3 years was 8.1% for primary augmentation, 18.9% for revision-augmentation, 8.3% for primary reconstruction, and 16.3% for revision-reconstruction.   

•     Lymphadenopathy - 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.   

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 un known, which in the future could be determined to be associated with breast implants. It should also be noted that the cited references include data from augmentation and/or reconstruction patients, as well as 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 ( ≤ 2) 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.

 

 

 

•    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 that a patient has a connective disease; however, you should advise your patient that she may experience these signs and symptoms after undergoing breast implantation. If a patient has an increase in these signs or symptoms, you should refer your patient to 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 si gnificantly 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 cancerOne 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 cancerOne 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.

 

 

• 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.

 

 

• Suicide - In several studies, a higher incidence of suicide was observed in women with breast implants. The 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.

 

 

• 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 in to breast milk during breastfeeding. Although there are no current establis hed 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 co mpared 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 devel opment of capsular contracture and lymphadenopathy. However, evidence against gel bleed being a significant contributing factor to capsular contra cture 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 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.   (Personal note: saline implants have a shell that is comprised of silicone and several other heavy metals, so this logic may be flawed. Also important to note that the "test" for safety over gel bleed was conducted over 30-90 day periods, not years or decades as we have seen with women who currently have implants)

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 biocompatible) 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. The test method was developed to represent, as closely as possible, conditions in the body surrounding an intact implant. The results indicate that only the LMW silicones D4, D5, and D6, and platinum, bled into the serum in measurable quantities. In total, 4. 7 micrograms of these three LMW silicones were detected. Platinum levels measured at 4.1 micrograms by 60 days, by which time an equilibrium level was reached and no more platinum was extracted from the device. 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.  

Mentor’s Core Study results indicate that the risk of any complication (including reoperation) at some point through 3 years after implant surgery is 36.6% for primary augmentation patients, 50.1% for revision-augmentation patients, 49.4% for primary reconstruction patients, and 47.5% for revision- reconstruction 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. One primary reconstruction pa tient and two revision-reconstruction patients in the Mentor Core Study were reported to have a new diagnosis of CTD according to a rheumatologist. These diagnoses were two cases of fibromyalgia, both at 1 year, and pyoderma gangrenosum at 1 year. These data should be interpreted with caution beca use there was no co mparison group of similar women without implants.     

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 ha nds, 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 and primary reconstruction patients. These in creases were not found to be related to simply getting older over time. No significant increases were found for any individual signs and symptoms in the revision-reconstruction patients. 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 dete rmined whether these increases were due to the implants or not. However, your patient should be aware that she may experience an increase in these symptoms after receiving breast implants.  

 

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