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Regulatory History of Breast Implants in the U.S.
1976 Congress passed the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. Breast implants were placed into Class II and reviewed through the premarket notification [510(k)] process.
1988 In response to emerging safety concerns, the FDA re-classified breast implants to class III devices (requiring premarket approval). However, in accordance with the law, they continued to be reviewed through the 510(k) process until the FDA issued a rule calling for submission of premarket approval applications (PMAs).
1991 – April The FDA issued a final rule calling for submission of PMAs for silicone gel-filled breast implants.
1991 – November The FDA held an Advisory Panel meeting to discuss several PMAs for silicone gel-filled breast implants. While the panel concluded that the manufacturers had failed to provide adequate safety and effectiveness data for their implants, they unanimously recommended that the FDA permit the implants to remain on the market.
1992 – January The FDA announced a voluntary moratorium on silicone gel-filled breast implants, requesting that manufacturers stop supplying them and surgeons stop implanting them, while the FDA reviewed new safety and effectiveness information that had been submitted.
1992 – February Based on new information, the FDA held a second Panel meeting to re-evaluate the safety of silicone gel-filled breast implants. This time the panel recommended that silicone gel-filled breast implants be removed from the market pending further evaluation of the new data.
1992 – April The FDA concluded:
None of the PMAs submitted for silicone gel-filled breast implants contained sufficient data to support approval.
Access to silicone gel-filled breast implants should continue for patients undergoing breast reconstruction or for replacement of existing silicone gel-filled breast implants (revision). Implants used for these indications should be considered to be investigational devices, and women who received them should be followed through adjunct clinical studies.
1992 – July The FDA approved Mentor's Adjunct Study protocol for its silicone gel-filled breast implants for reconstruction and revision patients only.
1998 – March The FDA approved Allergan’s (formerly Inamed) Adjunct Study protocol for its silicone gel-filled breast implants for reconstruction and revision patients only.
1998 – June The FDA approved Allergan’s investigational device exemption (IDE) study (i.e., Core Study) for its silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites. This is the Core Study for submission P020056.
2000 – March The FDA held an Advisory Panel meeting to discuss three saline-filled breast implant PMAs. The Panel recommended that the FDA approve two of the PMAs but not the third.
2000 – May The FDA approved the first PMAs for saline-filled breast implants. P990074 for Allergan (formerly McGhan) and P990075 for Mentor. These implants were approved for augmentation in women age 18 and older and for reconstruction in women of any age.
2000 – August The FDA approved Mentor's IDE study (i.e., Core Study) for its silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites. This is the Core Study for submission P030053.
2002 – July The FDA held an Advisory Panel meeting to update the Panel on postmarket (after approval) information and data for the two approved saline-filled breast implant PMAs.
2002 – December Allergan submitted a PMA (P020056) for its silicone gel-filled breast implants.
2003 – October The FDA held an Advisory Panel meeting to review Allergan’s PMA for its silicone gel-filled implants (P020056). In a 9 to 6 vote, the panel recommended approvable with conditions, including a minimum age requirement for augmentation.
2003 – December Mentor submitted a PMA (P030053) for its silicone gel-filled breast implants.
2005 – April The FDA held an Advisory Panel meeting to review Allergan’s updated PMA and Mentor’s PMA. In a 5 to 4 vote, the panel did not recommend approval of Allergan's PMA (due to a concern with one style in the application). In a 7 to 2 vote, the panel recommended approvable with conditions for Mentor's PMA. The panel recommended that FDA require conditions including a minimum age requirement for augmentation and Post-Approval Studies.
2006 – November The FDA approved Allergan and Mentor’s PMAs for silicone gel-filled breast implants. This was the first time silicone gel-filled breast implants were available for augmentation, in addition to reconstruction and revision, since the moratorium was established in 1992. As conditions of approval, each manufacturer was required to conduct 6 post-approval studies to further characterize the safety and effectiveness of their silicone gel-filled breast implants and to answer scientific questions that the premarket clinical trials were not designed to answer.
2011 – January The FDA issued a Safety Communication on anaplastic large cell lymphoma (ALCL) in women with breast implants. Based on a review of the scientific literature, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant.
2011 – June The FDA issued an Update on the Safety of Silicone Gel-Filled Breast Implants. It included preliminary results of the post approval studies Allergan and Mentor were required to perform as conditions of their silicone gel-filled breast implant 2006 approval.
2012 Breast Implant Helpline launched to help women with, deficiency claims, silicone breast implant Disease claims and Proof of manufacturer
The Class 7 breast Implant Claim Update is a resource information Update offered by the Breast Implant Helpline. Call the Breast Implant Helpline and speak to medical social worker about your silione breast implant claim and get connected to a female breast implant lawyer.
Class 7-Silicone Gel Breast Implant Fund
The Breast Implant Plan established a separate fund of money – $57.5 million – to make Expedited Release or Disease Payments to women who were implanted with certain types of silicone gel breast implants from 1976-1991. To be eligible, a claimant must have been implanted with a silicone gel breast implant made by one of the manufacturers listed below. Claimants who were implanted with a Dow Corning implant are not eligible to receive benefits from the class 7 fund.
If you have a silicone gel breast implant implanted from 1976-1991 from one of the following, you are a Silicone Material Claimant
If you have a silicone gel breast implant implanted from 1976-1991 from any of the following, you are a Participating Foreign Gel Claimant
- Cox-Uphoff (CUI)
- Societe Prometel
The deadline to file a Breast Implant claim for class 7 benefits was June 1, 2006. No new claims are allowed.
Class 7 Payments for Breast Implants
The Settlement Facility issued Expedited Release and Foreign Gel Claimant Payments to eligible claimants in the amount of $600.
Claimants in class 7 who applied for Disease and who "marshaled" their recoveries were sent a Disease Cash-Out Offer of $3,000. Claimants who reject the Disease Cash-Out Offer will have their disease claim reviewed and, if approved, paid up to 40% of the Class 5 compensation grid.
Class 7 Processing Update
Class 7 is a limited fund that can not pay ANY disease claims until all Class 7 claims are processed and all cure deadlines have expired. Because of this time constraint, the SF-DCT will perform an ACTD Discretionary review simultaneously with your Option 2 review when applicable
For More information of Your Class & Breast Implant Claim call the breast implant helpline and speak to a breast Implant lawyer today
PIP Breast Implant Warnings Hit Middle East
Karin Kloosterman | December 26th, 2011 | 13 Comments | Email this
ruptured pip breast implant france
Defunct French company PIP has sold leaky, industry grade silicon implants now being recalled. image via Globalpost
Thousands of faulty breast implants have been recalled by the French government for fears of leaks that could lead to cancer. A call to women has been issued in the Middle East to women from Israel all the way to Abu Dhabi. The defunct French company Poly Implant Prothese (PIP) has had its implant linked to cancer and other ill health effects. Some 30,000 women in France have been told to remove the implants.
In Israel for instance, some 850 women are estimated to have the implant, and the country has opened a hotline for women suspected of having the faulty implant call in. In France, the government is paying for the removal of PIPs, and will pay for new implants if the PIP implant was implanted for medical reasons.
While I never considered implants myself, I always considered them one of the grossest things a woman could do to her body.
Ironically the implant that makes her more “woman” robs her of the very reason why breasts exist: to breast feed her young. In a hyper-sexualized world where women pay thousands of dollars to look like a Baywatch bimbo it will just be a matter of time when bigger immune system effects from implants will be nailed down by science.
Even less intrusive add-ons to our bodies, such as wearing contact lenses, can have harmful effects on the immune system, especially in women, putting us at risk for immune system diseases. Have you ever worn contact lenses and felt your body was rejecting them? Imagine that feeling locked inside your breasts, as silicon droplets leak into your body In the U.S The Breast Implant Helpline is assisting women with breast Implant Claims.
Breast Implants have been shown to increase risk of connective-tissue diseases, such as systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, and scleroderma, and appropriately concludes that it is unlikely that common rheumatic diseases, such as rheumatoid arthritis, are associated with implants. The sample size is inadequate to assess the frequency of uncommon rheumatic diseases, such as systemic lupus, erythematosus , scleroderma, and the study methods did not allow the assessment of the prevalence of Sjogren's syndrome
In a US retrospective cohort study (1960–1996), 351 (4.8%) of 7,234 patients with breast implants and 62 (2.9%) of 2,138 patients who had undergone other types of plastic surgery reported subsequent rheumatoid arthritis (RA), scleroderma, systemic lupus erythematosus, or Sjögren’s syndrome (relative risk = 2.0, 95% confidence interval (CI): 1.5, 2.8). Risks of RA, scleroderma, and Sjögren’s syndrome were elevated both before and after 1992, when the Food and Drug Administration changed the status of breast implants to investigational. When records for these diseases were retrieved (35–40% retrieval rate) and blindly reviewed, two expert rheumatologists assessed only a minority of the cases as being “likely” (e.g., regarding RA, 16.5% for implant patients and 23.5% for comparison patients). Recalculation of incidence rates using “likely” diagnoses found relative risks of 2.5 (95% CI: 0.8, 7.8) for RA, scleroderma, and Sjögren’s syndrome combined and 1.9 (95% CI: 0.6, 6.2) for RA only. When the proportions deemed “likely” were applied to all self-reports, the estimated relative risks were 2.0 (95% CI: 0.7, 5.4) for the three disorders combined and 1.3 (95% CI: 0.5, 3.8) for RA. These results indicate that self-reports of connective tissue disorders are influenced by reporting and surveillance biases. Given the diagnostic complexities of these diseases, excess risks, if they exist, may be beyond detection even in a study of this size.
Received for publication December 12, 2003; accepted for publication April 15, 2004.
Considerable controversy has surrounded the long-term safety of silicone breast implants. Concerns regarding cancer risk have centered around breast cancer, hematopoietic malignancies, and sarcomas Clinical reports have raised additional concerns regarding the long-term risks of connective tissue disorders (CTDs). Although a number of epidemiologic investigations have assessed these relations they have been hindered by methodological limitations, including small sample sizes, limited follow-up, and imprecise information on either the exposures or the outcomes of interest.
In 1992, the US Congress directed the National Institutes of Health to undertake an investigation to assess the long-term safety of silicone breast implants. In response, the National Cancer Institute designed an epidemiologic follow-up investigation focused on the relation between cosmetic breast implants and subsequent cancer occurrence and overall mortality patterns. Several previous publications addressed these initial research goals While it was not the primary focus of the study, systematic follow-up of a large group of women who had received breast implants provided investigators with an opportunity to assess CTDs, many of which have received attention as possible consequences of exposure to silicone implants. In this paper, we address the impact of timing and types of breast implants on the long-term risks of various CTDs, considering both patient reports and medical verification of these conditions.
MATERIALS AND METHODS
This retrospective cohort study has been described previously Institutional review boards at the National Cancer Institute and the organizations involved in data collection approved the study. Eligible study subjects comprised women who had had initial bilateral augmentation mammoplasty before 1989 at one of 18 plastic surgery practices in six areas (Atlanta, Georgia; Birmingham, Alabama; Charlotte, North Carolina; Miami and Orlando, Florida; and Washington, DC). Since breast cancer was a primary outcome of interest, patients who had received implants following treatment for breast cancer were not included. A total of 13,488 eligible study subjects were identified, comprising all augmentation mammoplasty patients at each practice who met the eligibility criteria. In addition, 3,936 comparison subjects from these same practices were identified, comprising similar-aged patients who had undergone other types of plastic surgery not involving silicone during the same time period. The major types of plastic surgery included abdominoplasty or liposuction, blepharoplasty or rhytidectomy (operations for removal of wrinkles on the face and neck), and rhinoplasty, otoplasty, mentoplasty, or genioplasty (operations involving the nose, ear, or chin). The number of comparison patients was considerably lower than the number of implant patients, since the emphasis of the study was on cancer outcomes, for which external comparison incidence rates are available.
Trained abstractors reviewed medical charts and entered data directly into laptop computers using standardized software. Information on vital status and location was sought through various tracing sources. In total, 10,778 (79.9 percent) of the implant patients and 3,214 (81.7 percent) of the comparison patients were traced, with 364 being identified as deceased (245 implant patients and 119 comparison subjects). Death certificates were obtained for 91.4 percent and 95.8 percent of the deceased implant and comparison patients, respectively.
Beginning in June 1995, subjects were sent mailed questionnaires requesting information on demographic factors, subsequent plastic surgeries, current health status, and lifestyle factors that could affect health. Respondents were asked whether they had ever received a physician’s diagnosis of rheumatoid arthritis, arthritis of another type, scleroderma, systemic lupus erythematosus, Sjögren’s syndrome, Raynaud’s phenomenon, fibrositis/fibromyalgia, vasculitis, chronic fatigue syndrome, or multiple sclerosis. They were also asked whether they had received any other CTD diagnosis and, if so, which one. For each condition, patients were asked to provide their age at first diagnosis and the physician’s name and address. Nonrespondents were given the opportunity to complete questionnaires by telephone. Questionnaires were obtained from 7,447 (70.7 percent) of the living implant patients and 2,203 (71.2 percent) of the comparison patients.
Person-years were accrued beginning 1 year after initial plastic surgery and continuing through the earliest date of development of a CTD, the date on which the patient was last known to be alive and free of any CTD, or December 31, 1996. Patients with a CTD diagnosed prior to their initial plastic surgery were excluded from analysis of that disease; further evaluation that excluded such patients from all analyses showed no substantial changes in risk estimates. Poisson regression methods as implemented in the Epicure AMFIT module were used to calculate relative risks (implant patients vs. comparison patients), compute 95 percent confidence intervals, and adjust for potentially confounding variables. For all analyses, relative risks were adjusted for age at follow-up, calendar period of follow-up, and race. Other factors, such as age at surgery, year of surgery, time since surgery, or specific predictors of CTDs (education, family history), were included in the regression models, as necessary, for evaluation of their roles as potentially confounding factors or for examination of variations in the relative risk. The final analytical data set, which excluded subjects who developed CTDs within 1 year of initial plastic surgery (59 implant patients and 21 comparison patients) and persons of races other than White or Black (154 implant patients and 44 comparison patients), consisted of 7,234 implant patients and 2,138 comparison patients.
The mortality of the subjects through the end of 1997 was also examined
Medical review of reported CTDs
We attempted to retrieve and review medical records for the CTDs that have been most consistently related to breast implants and for which patient reports indicated persistent elevations in risk over time. Notations regarding implants were blacked out, and extraneous information in the records of comparison patients was similarly marked, to blind the reviewing rheumatologists as to patient implant status. Using a standardized abstract form, two board-certified rheumatologists (L. M. B. and O. D.) reviewed the records to determine their adequacy and to assess whether the patient’s history, the physical examination, and radiographic and laboratory findings supported the diagnoses reported. The reviewers assessed the likelihood of each reported diagnosis (likely, unlikely, unable to assess). Instances of disagreement between reviewers were resolved by having both rheumatologists re-review the record and come to consensus. For diagnoses deemed “likely,” the reviewers determined whether standardized criteria for rheumatoid arthritis or Sjögren’s syndrome were met. For diagnoses deemed “unlikely,” the reviewers were asked to indicate a probable alternative diagnosis (chronic fatigue syndrome, fibromyalgia, osteoarthritis, other condition, no condition, or unknown).
Although implant patients were somewhat younger than comparison patients at the time of their plastic surgery (mean ages of 34.6 years and 41.5 years, respectively), the mean years of initial surgery were similar (1983.0 vs. 1984.3). The average length of follow-up was 12.1 years among the implant patients and 11.1 years among the comparison patients. The maximum lengths of follow-up were 31.6 years and 27.6 years among the implant and comparison patients, respectively.
Three hundred fifty-one (4.8 percent) of the implant patients and 62 (2.9 percent) of the comparison patients reported a diagnosis of one of four major CTDs (rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or Sjögren’s syndrome), generating a relative risk of 2.0 (95 percent confidence interval (CI): 1.5, 2.8) (table 1). Significant risk elevations were noted for rheumatoid arthritis (relative risk (RR) = 1.9, 95 percent CI: 1.4, 2.7), systemic lupus erythematosus (RR = 2.1, 95 percent CI: 1.1, 4.2), and Sjögren’s syndrome (RR = 11.7, 95 percent CI: 2.5, 54.9). Scleroderma was associated with a threefold risk on the basis of 23 implant patients and three comparison subjects. Significant risks were also observed for Raynaud’s phenomenon (RR = 2.6, 95 percent CI: 1.3, 5.1) and chronic fatigue syndrome (RR = 2.4, 95 percent CI: 1.6, 3.6). Nonrheumatoid types of arthritis were more commonly reported by the implant patients than by the comparison patients, generating a modestly increased but significant risk (RR = 1.3, 95 percent CI: 1.1, 1.6). Although it was commonly reported, fibromyalgia was not associated with any significant risk (RR = 1.3), nor was the less frequently reported vasculitis (RR = 1.4). A large number of patients reported having “other CTDs,” but most were vaguely defined or should not have been considered CTDs (e.g., bursitis, carpal tunnel syndrome). A number of implant patients reported having atypical or undifferentiated (12 implant patients) or mixed (24 implant patients, one comparison patient) CTDs—diagnoses developed for implant patients whose symptoms did not fit recognized diagnostic categories. Specific references to other types of definite CTDs (e.g., polymyalgia rheumatica) were rare and not unusually represented among the implant patients.
We analyzed disease associations according to whether the diseases were reportedly diagnosed prior to or during/after 1992, when the Food and Drug Administration changed the status of breast implants to investigational. The overall risk of the major CTDs was higher for conditions diagnosed during or after 1992 (RR = 2.6) as compared with before 1992 (RR = 1.7), although both risks were significant (table 2). The risks were similar in the two time periods for rheumatoid arthritis, scleroderma, and Sjögren’s syndrome, but for a number of conditions the risks were substantially higher for diagnoses occurring in the later period. This was true for lupus, Raynaud’s phenomenon, fibromyalgia, chronic fatigue syndrome, and “other CTDs.” However, the risk of chronic fatigue syndrome was significantly elevated in both the earlier and the later time periods. Only for one condition, vasculitis, was the relative risk higher (though nonsignificant) for diagnoses in the earlier time period (RR = 2.6), on the basis of 10 reported cases among the implant patients.
In additional analyses, we examined risks for conditions with sufficient numbers of exposed persons by age at, calendar period of, and years since initial implantation For the major CTDs, there was no evidence of a trend in risk according to any of these parameters. This was also generally true when individual conditions were considered, although for several conditions (e.g., scleroderma, Sjögren’s syndrome) the risks were difficult to interpret because of small numbers. We also examined the effects of timing of implantation according to whether conditions were diagnosed prior to or during/after 1992. Given the evidence that breast implants deteriorate over time, we focused on relations by the number of years since initial implantation. This analysis showed no relation with years since implantation for diseases diagnosed prior to 1992 but increasing risks after this time (e.g., for the major CTDs, in comparison with women with less than 5 years of follow-up, the risks were 1.5, 1.6, and 2.0 for 5–9, 10–14, and ≥15 years of follow-up, respectively; comparable risks for women diagnosed before 1992 were 1.2, 1.3, and 0.8). This post-1992 pattern largely reflected trends for rheumatoid arthritis.
Given that rates of location and response varied depending on the source of patients, we subdivided medical practices from which patients were recruited according to their average rates of location (<75 percent, 75–84 percent, and ≥85 percent) and questionnaire completion (<70 percent, 70–74 percent, and ≥75 percent). There appeared to be no consistent pattern of risk according to these groupings. We further grouped practices according to the combination of location rate and response rate. The relative risk for the major CTDs was 2.4 for practices with the highest rates and 1.9 for practices with the lowest rates. We also examined risks for the demographic subgroup with the highest questionnaire response rate (>70 percent)—namely, older White subjects who had undergone surgery after 1981. The risk of major CTDs, as well as the risk of most individual diseases, was similar to overall risks (for the major CTDs, RR = 1.8, 95 percent CI: 1.0, 3.1).
Of the patients who received breast implants, 49.7 percent received silicone gel implants, 34.1 percent received double lumen implants, 12.2 percent received saline implants, and 3.9 percent received other/unspecified types of implants. The relative risk of major CTDs was 2.4 for silicone gel implants (210 events among implant patients; 95 percent CI: 1.8, 3.4), 1.8 for double lumen implants (100 events; 95 percent CI: 1.3, 2.6), 1.7 for saline implants (34 events; 95 percent CI: 1.0, 2.7), and 0.9 for other/unspecified implants (seven events; 95 percent CI: 0.4, 2.1). Risks of individual diseases were also generally somewhat higher for women with silicone gel implants, although the differences by implant type were not significant.
Examination of causes of death showed that none of the implant or comparison patients had a CTD as an underlying or contributory cause of death.
Rheumatologic review of conditions
We attempted to confirm diagnoses of rheumatoid arthritis, scleroderma, and Sjögren’s syndrome in physicians’ records. Permission for record retrieval was obtained from 70.4 percent of implant patients and 53.7 percent of comparison patients. We retrieved 56.4 percent and 65.5 percent of these patients’ records, respectively; the records comprised 114 patients with rheumatoid arthritis, eight with scleroderma, and 20 with Sjögren’s syndrome.
Most diagnoses were insufficiently supported, either because the records were incomplete or because clinical criteria were not met (table Consensus review found the diagnosis of rheumatoid arthritis to be “unlikely” for 71.1 percent of implant patients and 64.7 percent of comparison patients. The diagnosis was supported for 16.5 percent of implant patients and 23.5 percent of comparison patients. American College of Rheumatology criteria were met by eight of the 16 implant patients and three of the four comparison patients with “likely” diagnoses.
Given the rarity of scleroderma and Sjögren’s syndrome, reports were difficult to assess, particularly among comparison subjects. Furthermore, a number of reports of both diseases were classified as unassessable. For Sjögren’s syndrome, this was often due to the absence of diagnostic tests, including biopsies and serologic testing needed to distinguish Sjögren’s syndrome from other causes of xerostomia and dry eyes.
For those records with diagnoses assessed as unlikely, each reviewer was asked to assign a probable alternative diagnosis. For reports of rheumatoid arthritis, osteoarthritis was assigned most often among the implant patients (37.7 percent), followed by fibromyalgia (24.6 percent) and both osteoarthritis and fibromyalgia (14.5 percent). Comparable percentages among the comparison patients were 63.6 percent, 0 percent, and 9.1 percent. Among the seven unlikely reported cases of Sjögren’s syndrome among implant patients, two were considered potential cases of fibromyalgia, one was considered osteoarthritis, and one was considered both diseases. Both reported cases of unlikely scleroderma among the implant patients were considered possible cases of fibromyalgia.
Range of risk estimates
We calculated incidence rates and relative risks for diseases that were considered likely by both reviewers For rheumatoid arthritis, scleroderma, and Sjögren’s syndrome combined, the relative risk was 2.5 (95 percent CI: 0.8, 7.8) on the basis of 24 implant patients and four comparison patients. Rheumatoid arthritis was the major contributor to this risk, occurring among 16 implant patients and four comparison patients (RR = 1.9, 95 percent CI: 0.6, 6.2). For comparative purposes, the relative risks based on self-reports were 2.2 (95 percent CI: 1.6, 3.0) for all three conditions and 1.9 (95 percent CI: 1.4, 2.7) for rheumatoid arthritis. The absence of confirmed cases of either scleroderma or Sjögren’s syndrome among the comparison patients precluded derivation of reliable point estimates, but the lower 95 percent confidence limits for both of these risks were 0.4.
Given concerns that we were unable to retrieve all of the medical records for self-reported conditions, we also derived estimates of risk for all patients using confirmation rates based on patients with retrieved records. This analysis gave us an estimated relative risk of 2.0 (95 percent CI: 0.7, 5.4) for all three conditions and 1.3 (95 percent CI: 0.5, 3.8) for rheumatoid arthritis.
The design of this investigation and the characteristics of the assembled cohort offered many advantages for studying cancer risk and cause-specific mortality in relation to cosmetic breast implant surgery, the primary objectives of the study. These features include large numbers of implant patients (representing all patients from specific practices), extended follow-up, a practice-based comparison group, and the availability of questionnaire information on covariates. These features provide advantages in assessing the relation of breast implants to CTDs as well. However, in contrast to the relation between cancer and mortality, there are no well-accepted age-, race-, sex-, and calendar-time-specific population incidence rates for CTDs. Thus, our study was dependent on comparisons of rates in the implant and comparison patients; for rare diagnoses (the majority), this involved small numbers and unreliable rates. In addition, the complex clinical presentation of many CTDs and the variable criteria used to diagnose these diseases make reliable identification of cases difficult.
In interpreting the results of this study, potential effects of selection, recall, and surveillance biases must be considered. Of particular concern is the fact that many of the disease relations were primarily associations with conditions reportedly diagnosed in 1992 or later. The difference in risks between the two time periods was most apparent for lupus, Raynaud’s phenomenon, fibromyalgia, and chronic fatigue syndrome, the most graphic example being lupus: The relative risk was 0.9 in the era prior to extensive publicity and 5.9 afterward. Although trends by time of diagnosis could reflect the influence of implant leakage, given the evidence of deterioration of implants over time specific analyses that addressed relations by latency showed increasing risks’ being restricted to post-1992 diagnoses. This suggests that the publicity surrounding possible disease associations in the early 1990s may have contributed to the observed time trends.
Three conditions—rheumatoid arthritis, scleroderma, and Sjögren’s syndrome—continued to show elevations in risk even in the earlier time period and were of concern given speculations from other investigations of a link with breast implants. However, self-reports of CTDs for all patients, with or without implants, are subject to reporting and diagnostic biases and must be cautiously interpreted. Our confirmed risks were dependent on obtaining consent to retrieve records and on retrieving the relevant records when consent was received—challenges also experienced in another investigation . In analysis based on confirmed records, which involved considerably smaller sample sizes and may have been influenced by a variety of selection factors, the risk for the three conditions was 2.5; it dropped to 2.0 when we also factored in completeness of record retrieval. Both estimates were nonsignificant. Recognized differences in lifestyle factors between implant and comparison patients further complicated the interpretation of these risks, especially given the absence of many identified risk factors for these CTDs. Thus, the influence that confounding factors might have had on the risk estimates cannot be dismissed.
We had the most power to evaluate risks for rheumatoid arthritis. On the basis of self-reports, we saw no trends in risk with any time-related parameters, including interval since implantation. This raises questions regarding biologic plausibility. Several investigations have suggested small but nonsignificant risk increases for this disease among implant patients , though several other cohort and case-control studies have not supported a connection. However, many of these investigations had small sample sizes and short follow-up times. In one of the investigations that suggested a small increase in risk subsequent confirmation of reported CTDs found evidence of overreporting; only 22.7 percent of the self-reported cases were confirmed This was similar to our investigation, wherein retrieval of medical records confirmed only 17 percent of the reported cases, possibly reflecting a lack of awareness by the public of differences between rheumatoid arthritis and other types of arthritis (e.g., osteoarthritis). Further complicating the interpretation of self-reports of rheumatoid arthritis in our study was the fact that a somewhat higher percentage of cases were confirmed in the comparison patients than in the implant patients. When analyses were restricted to cases judged likely by the two rheumatologists, the risk fell to less than 2 and became nonsignificant. Furthermore, when we factored in our ability to retrieve records to confirm self-reports, our estimate of risk was 1.3, also not significant.
On the basis of clinical studies, the CTD that has been most consistently related to breast implants is scleroderma. This condition is difficult to study epidemiologically given its rarity in the general population, with estimates of annual disease incidence in females of 1.6 cases per 100,000 (45). In the largest cohort study, a relative risk of 1.84 (95 percent CI: 0.98, 3.5) was found on the basis of 10 observed cases among implant patients (23). The relation of this condition to breast implants has frequently been assessed in case-control investigations, with most not showing a relation (16, 21, 24, 46). In our study, 23 implant patients and three comparison patients reported scleroderma, resulting in a nonsignificant threefold risk elevation. Of the retrieved medical records, only 29 percent of cases among the implant patients were assessed as likely, for a total of two confirmed cases. The one comparison patient record failed to support the diagnosis. Thus, with no reliable estimate of comparison rates, we cannot address the likelihood of an association. What is clear is that any excess risk of scleroderma in implant recipients, if present, is likely to be small in absolute terms.
Sjögren’s syndrome was also of concern on the basis of prior clinical and epidemiologic literature, as well as preliminary self-report findings in this study. This is also a rare condition, with an annual estimated incidence of four cases per 100,000 population One meta-analysis noted a significant increase in this condition, largely reflecting risks from one investigation Our relative risk for Sjögren’s syndrome based on self-reports was the largest of any observed, but whether any excess risk would remain for validated diagnoses is unclear. As with scleroderma, any increase in absolute risk, should it remain, would be small.
In this investigation, we also assessed the risks of fibromyalgia and vasculitis, because implant patients have reported symptoms often associated with these diseases . Furthermore, one study found a relation between implant leakage and increased risk of fibromyalgia Self-reports of fibromyalgia or vasculitis were not found to be related to any sizeable risk in our study. However, chronic fatigue syndrome was associated with a modest increase in risk. This relation, though substantially more pronounced for diagnoses reported during or after 1992, was also present for earlier diagnoses. The diagnostic complexities of chronic fatigue syndrome are well recognized ; the symptoms leading to medical assistance and the criteria used to confirm the disease are associated with considerable uncertainty. Since this was not a condition that we attempted to confirm, we were unable to assess the extent to which defining criteria were present.
Our study was designed to assess only established CTDs. However, clinical observations have suggested that breast implants may lead to a new condition that does not meet established criteria for a recognized CTD. Although results from a case-control investigation provided some support for this several recent record-linkage studies in Scandinavia failed to note unusual symptoms among women with breast implants . Study of the issue is complex, especially since the suggestion of this entity is usually prompted by the presence of a breast implant. Appropriate evaluation would require a study design that included standardized histories and examinations in a large sample of implant patients and appropriate comparison patients.
This investigation confirmed the complexities of evaluating the relation between breast implants and the risk of CTDs. It is clear that a variety of selection and reporting biases may be involved, as evidenced in the present study by overreporting of conditions by both implant and comparison patients and the difficulty of confirming conditions according to defined clinical criteria. Our investigation had the most power to address relations with rheumatoid arthritis. Therefore, it is of interest that our risk estimates (on the basis of cases considered likely by expert chart review) were between 1.3 and 1.9 and not statistically significant. Confidence intervals in previous studies addressing the relation of breast implants to rheumatoid arthritis have included this level of risk. Thus, future studies designed to resolve the question of a possible association between implants and rheumatoid arthritis or other CTDs would need to be very large (especially to address such rare outcomes as scleroderma and Sjögren’s syndrome) and include well-validated and documented cases and unbiased assessments of exposure. To this end, the levels of risk that we observed for CTDs may be useful in determining sample sizes needed.
Reprint requests to Dr. Louise A. Brinton, Epidemiology and Biostatistics Program, Division of Cancer Epidemiology and Genetics, National Cancer Institute, 6120 Executive Boulevard, Room 7068, Rockville, MD 20852-7234 (e-mail:
Breast Implant Helpline in the U.S is helping women with breast Implant Claims and just recently
39,000 breast Implant claims have not been settled yout not settled yet. Are one of these yours? Call the Breast Implant Helpline today and speak to a female medical social worker and be connected to a female Breast Implant lawyer. Breast Implants Litigation Cases dealing with the Settlement Facility,Dow Corning Trust ,(SF-DCT), Revised Settlement Plant (RSP) ,MDL-926 Claims are still open. Learn if you qualify.
Breast Implant recall Helpline is here for Women who have pending litigation and have filed a claim.
Breast Implants are now being linked to Lupus
NOTICE YOU HAVE TILL 2019 TO FILE
Since Breast Implant Litigation involves Federal Law in the Federal Courts You will need an experienced breast implant lawyer Are you a member of the Breast Implant Class Action Settlement? If you have registered for the Dow Corning Class Action,there are facts you must know.Have you provided proper proof of your implant manufacturer? Have you been able to locate the doctor who performed your surgery or your medical records? Has the Claims Board rejected your claim due to deficiencies in your medical records? The Breast Implant Helpline is ready to help you.
Breast Implants Linked to Cancer
(FDA) has advised that breast implants, whether composed of saline or silicone, are linked to Anaplastic Large Cell Lymphoma (ALCL), a cancer of the immune system. It issued a breast implant warning in the form of a safety communication on its web site.
Breast Implant Complications Symptoms
- Collection of fluid
- Asymmetric breast size
- Hardening of the breast area
- Masses surrounding the breast area
The FDA found that women with leaking silicone implants are more likely to report several serious, debilitating illnesses, compared to women whose implants have not broken.
Your Dow Settlement Claim:
The Settlement Facility for the Dow Corning Trust (SF-DCT) is current in processing class 5 claims for disease and explant benefits. Reviews of Class 7 disease claims, however, are not all completed yet. Class 7 claims found to be deficient will have one year from the date of their notification letters to try to cure the deficiencies. The deadline to file an Explant Claim (if you have your Dow implants removed and not replaced with silicone) is 6/2/2014,The deadline to file either a Disease Claim or an Expedited Release Claim is 6/3/2019.
THE MDL-926 CLOSES ON DECEMBER 15, 2010
If you have an implant made by any of the companies participating in the Revised Settlement Program ("RSP"), you must submit any and all claims you have to the MDL-926 Claims Office by December 15, 2010. No new claims will be accepted by the MDL 926 Claims Office for the RSP after this date.
Call the Breast Implant Helpline Today for Help with a Deficientcy Notice.