April 21, 2021
National Center for Health Research’s Comments on the Agency for Healthcare Research and Quality’s Draft Report on Breast Reconstruction After Mastectomy
We are writing to express our views on the Agency for Healthcare Research and Quality’s (AHRQ) draft report on Breast Reconstruction after Mastectomy.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
This draft report states that it evaluates different breast reconstruction options for women either after mastectomy for breast cancer or as breast cancer prophylaxis, so that patients, clinicians, health system leaders, and policy makers can make “well-informed decisions and thereby improve the quality of healthcare services.” Based on our work with thousands of breast cancer patients, however, we must conclude that this review does not provide answers to important questions that are necessary to succeed in those worthy goals.
We have identified a number of shortcomings of the report, which we urge you to address before the report is finalized.
First, the report assumes that the only kind of reconstruction after a mastectomy is to replace the breasts. It includes no discussion of the choice made by many women to “go flat” with cosmetic surgery to make the flat chest look as attractive as possible. This is important, since research has shown that 44% women did not have reconstructive surgery to replace their breast(s) after their mastectomy. This oversight should be addressed because the current draft of the report makes breast reconstruction seem inevitable, which patients tell us makes it difficult to convince healthcare providers that they do not want breast reconstruction.
It is also essential to include the information that mastectomies for women with very early stage breast cancer are much more common in the U.S. than any other country. Although the data are clear that women with early-stage breast cancer who undergo lumpectomy live as long as women who undergo mastectomies, the report fails to mention that when mastectomies are unnecessary, choosing lumpectomy will make reconstruction (with its risks) also unnecessary.
In general, the lack of discussion of complications and serious health consequences from reconstruction could mislead healthcare providers who rely on this report for information about the safety of these procedures. For example, when discussing the risks of reconstruction with breast implants, the draft only mentions breast implant associated anaplastic large cell lymphoma (BIA-ALCL) 4 times: twice on page 19, once in Figure 2 (on page 6), and briefly on page 88. BIA-ALCL was not mentioned as a risk in the section of the report comparing different types of implants. The report states that the studies eligible for the review did not address the risk of neoplasms, particularly BIA-ALCL, but that is not adequate justification for almost ignoring a potentially fatal adverse event. Moreover, BIA-ALCL is described in the report as “an extremely rare” type of cancer, although recent data indicates it occurred in one of every 354 mastectomy patients reconstructed with textured implants, according to a study conducted at Memorial Sloan Kettering Cancer Center. In addition, Figure 2 in the draft report lists BIA-ALCL as a “surgical complication.” That is not accurate. It is a systemic disease caused by implants.
The report barely mentions the autoimmune, connective tissue, and neurological risks associated with breast implants, known as “Breast Implant Illness.” Although the report gives passing mention of “systemic symptoms” twice on page 19, there is no discussion of well-designed, published studies that reported statistically significant increases in these symptoms or any mention of the term Breast Implant Illness. In 2019, the FDA held a 2-day meeting focused primarily on breast implant illness, and researchers have reported statistically significant increases in these symptoms and related diseases [for example, see 3,4]. Moreover, a 2020 study examining 750 patients who were diagnosed with symptoms of breast implant illness found that after their breast implants were carefully removed, symptoms such as joint and/or muscle pain, loss of hair, memory loss/cognitive problems, chronic fatigue, breast pain, persistent skin inflammation, food intolerance, and difficulty breathing disappeared or improved significantly.
Furthermore, the mention of these systemic symptoms appears to be conflated with discussion of BIA-ALCL on page 19, when it states “These risks of systemic symptoms and BIA-ALCL led the U.S. Food and Drug Administration (FDA) to request a recall of one manufacturer’s textured implant and tissue expander in 2019 and to recommend a boxed warning for all breast implants in 2020.” The recall was due to BIA-ALCL, not to Breast Implant Illness symptoms.
The draft report notes that it also evaluates breast reconstruction options for those women who had prophylactic mastectomies, but the report barely mentions this, merely stating that more women who have undergone prophylactic mastectomies need to be enrolled in clinical studies. Unfortunately, the report lacks information that is relevant for the diverse groups of women who undergo prophylactic mastectomies. Additionally, BRCA mutations are not mentioned in the report, despite being a key factor that influences women’s decision to undergo prophylactic mastectomies. We therefore strongly urge AHRQ to remove the statement that this review is relevant for women who had mastectomies as breast cancer prophylaxis and that it provides guidance to healthcare providers on this issue.
There is also limited information in the report regarding outcomes of importance to patients. The report lists surgical complications as well as patient satisfaction with aesthetic results and psychosocial well-being after only 2 years, but the report does not describe whether patient satisfaction was reported anonymously or to the surgeons; the latter would clearly bias the results. In addition, the report does not explain that there is no scientifically solid data on long-term (longer than 10 years) complication rates comparing different types of implant-based reconstruction (IBR). Since breast reconstruction is intended to last for decades, this limits how informative the report actually is.
Finally, it is stated in the report that the conclusions apply generally to mostly White, middle-aged, non-obese women in high-income countries who are being treated for breast cancer, which raises questions about how generalizable the report is to all women considering mastectomy and reconstruction. That shortcoming should be explicitly acknowledged.
- BreastCancer.org. Going Flat: Choosing No Reconstruction. https://www.breastcancer.org/treatment/surgery/reconstruction/no-reconstruction. Updated March 9, 2019.
- Cordeiro PG, Ghione P, Ni A, Hu Q, Ganesan N, Galasso N, Dogan A, Horwitz SM. Risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3546 women prospectively followed long term after reconstruction with textured breast implants. Journal of Plastic, Reconstructive & Aesthetic Surgery. 2020 May 1;73(5):841-6.
- U.S. Food and Drug Administration. March 25-26, 2019: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement https://www.fda.gov/advisory-committees/advisory-committee-calendar/march-25-26-2019-general-and-plastic-surgery-devices-panel-medical-devices-advisory-committee
- Watad A, Rosenberg V, Tiosano S, Cohen Tervaert JW, Yavne Y, Shoenfeld Y, Shalev V, Chodick G, Amital H. Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis. International Journal of Epidemiology. 2018; 47(6):1846-54.
- Wee CE, Younis J, Isbester K, Smith A, Wangler B, Sarode AL, Patil N, Grunzweig K, Boas S, Harvey DJ, Kumar AR. Understanding Breast Implant Illness, Before and After Explantation: A Patient-Reported Outcomes Study. Annals of Plastic Surgery. 2020; 85(Suppl):S82.