Hartford Breast Implants doctors

The FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. While the FDA continues to allow the sale and use of approved breast implants, the FDA has stated, “additional data is needed to fully understand the possible relationship between ALCL and breast implants.” The FDA has stated, “women with implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL.”

• According to the FDA, the incidence of ALCL of the breast is 3 per 100,000,000 women
• According to the FDA 60 cases of ALCL of the breast have been reported for the 5-10 million women with breast implants 

The medical community is in the process of gathering more information about breast implant- associated ALCL so that we can better understand this condition and the potential risk breast implants pose. s of January 26, 2011, approximately 60 cases of breast implant-associated ALCL have been identified by the FDA. This number is based upon 34 case reports in the medical literature and additional cases reported directly to the FDA. Tally case reports in the medical literature and relying on adverse event reporting to the FDA are unreliable methods of determining the actual incidence of a disease or condition, and as such, we really don't know how many women with breast implants have developed ALCL and therefore cannot reliably estimate risk. Furthermore, even if we could accurately know how many have implants and how many of those women with developed ALCL, we still would not be able to accurately assess risk. That's because we would also need to know how long each of those women had their implants in. The reason time is important here is because ALCL seems to develop years after breast implants are placed-8 years on average from implant placement to ALCL diagnosis for the cases reported in the medical literature-so counting women who had implants placed last year could be misleading.

Furthermore, because the information about ALCL was not reported in a uniform way, we do not now for certain whether, as you asked, particular implants or implant positions are more likely to lead to ALCL. Furthermore, at this time, we have only limited understanding of  breast implant-associated ALCL. For example, in the medical literature, only 19 of the 34 reported cases include information about ALCL recurrence or the development of systemic lymphoma. Of these, 14 patients remained free of ALCL during the follow-up period, however, the average reported follow-up period was only  one year. The FDA presently recommends that if a woman develops breast implant-associated ALCL, her doctors should “develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team. Because of the small number of cases worldwide and variety of available treatment options, there is no single defined consensus treatment regimen.” Reported cases of ALCL have been treated with one or more of the following: surgery, radiation and chemotherapy. According to published information on the FDA website, “Because of the small number of cases and the short median duration of follow-up, the FDA believes it is premature to draw conclusions regarding the prognosis of ALCL in women with breast implants.”

The bottom line: An association between breast implants and ALCL has been identified and we are in the process of learning more about this malignancy.

The FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. While ALCL is not breast cancer, it is a malignancy. Furthermore, although a conclusive causal relationship has not yet been established, it is presently thought that breast implants can play a role in the development of ALCL; the number of identified cases far exceeds the number of expected cases (3 cases of ALCL are expected per 100,000,000  women without implants).  While the FDA continues to allow the sale and use of approved breast implants, the FDA has stated, “additional data is needed to fully understand the possible relationship between ALCL and breast implants.” At the time of this writing, the FDA believes, “women with implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL.”

The medical community is in the process of gathering more information about breast implant- associated ALCL so that we can better understand this condition and the potential risk breast implants pose. Women considering breast implants should inform themselves about ALCL and weigh the risks, the uncertainty, and the potential benefits of breast implants for themselves.

According to the FDA report, as of January 26, 2011, approximately 60 cases of breast implant-associated ALCL had been identified by the agency. This number is based upon 34 case reports in the medical literature and additional cases reported directly to the FDA. Case reports in the medical literature and adverse event reporting to the FDA are know to be unreliable methods of determining the true or actual incidence of a disease or condition. The FDA believes that only 1-10% of adverse events are actually reported to the agency, so it would not be surprising to find that with time, the actual number of cases is greater than what we know so far.

If you are considering breast implants, it is important to understand that looking at risk from the standpoint of “how many women with breast implants have developed ALCL” (i.e., ALCL cases per total number of women who have had breast augmentation) does not tell the whole story about a woman’s real risk. Since the actual number of women with breast implants is unknown—the FDA states that there are between 5 and 10 million women with breast implants worldwide—any estimation of risk based on 10 million women would immediately double if the number of women with breast implants were, in fact, 5 million. Furthermore, since ALCL appears to develop many years after breast implants are placed (the average latency, or time to development of ALCL in the reported cases was 8 years) <i>and</i> since many women only recently underwent breast augmentation surgery (296,203 breast augmentations in 2010 according to the ASPS), looking at the incidence of ALCL in relation to the total number of women who have had breast implants placed may be misleading. This is because hundreds of thousands, or possibly millions, of women who only relatively recently underwent breast augmentation and thus would not yet be at significant risk for developing ALCL—they are, so to speak, still in the latency or “incubation” period—would be counted in a statistics that measure "how many women with breast implants develop ALCL".  In other words, the inclusion of these women who recently underwent breast augmentation in the calculation effectively “dilutes” the ratio and thus dilutes the appearance of risk. A more accurate way to represent the incidence of a condition with a long latency period would be to express the number of cases in terms of “patient exposure time” (which is like looking at "man-hours worked" rather than the number of workers who did work).

According to the FDA:

• Women with implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL.
• Because of the small number of cases worldwide and variety of available treatment options, there is no single defined consensus treatment regimen.
• Because of the small number of cases and the short median duration of follow-up, the FDA believes it is premature to draw conclusions regarding the prognosis of ALCL in women with breast implants.
• Women who have breast implants should monitor their breast implants and contact their doctors promptly if they notice pain, swelling or any changes in or around their breast implants. There is no reason to contact their doctors if they have no symptoms.
• If a woman is considering breast implant surgery, she should discuss the risks and benefits of the procedure with her doctor.