Tag Archives: mastectomy

FDA considers black box warning for all breast implants

Mariel Carbone, WCPO Cincinnati: February 09, 2020


Although many other survivors choose implants after their mastectomies, [Lily McBreen is] adamant that she won’t. Having almost lost her life once, she’s worried the side effects of receiving breast implants could endanger it again.

[…]

“I wanted to avoid the rheumatological symptoms that have been out in the news for so many decades,” she said. “There has been so many accounts of women complaining of problems with them.”

Those symptoms, which women are calling “breast implant illness,” are among the many reasons the United States Food and Drug Administration could soon take extreme measures when it comes to educating the public about implants.

[…]

Currently, the black box warning exists only as a draft while the FDA continues to consider its implementation.

The draft warning outlines three main concerns.

First, “breast implants are not considered life time devices” and women may require more surgery if complications occur.

It also states that implants have been associated with BIA-ALCL.

[…]

Finally, it describes how some patients have reported a variety of symptoms, including “joint paint, muscle aches, confusion, chronic fatigue, autoimmune disease and others.”

The FDA is also proposing a patient decision checklist, which would include situations in which the device should not be used, considerations for a successful breast implant candidate, risks of surgery, the importance of using an appropriate physician, the risk of BIA-ALCL and other symptoms and discussion of other options.

Still, some have said these proposals don’t go far enough, including Diana Zuckerman who is President of the National Center for Health Research. The center initiated the Breast Implant Working Group, which is made up of six experts including patient advocates and plastic surgeons.

“The FDA’s draft Black Box warning is too vaguely worded on BIA-ALCL and breast implant illness, and includes jargon that will not be understood by all patients,” the working group said in a statement. “The FDA draft Black Box states that ‘breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).’ Association implies correlation rather than causation. In fact, the evidence is clear that breast implants can cause BIA-ALCL.”

Read the original story here.

Less Radical Surgery Is a Healthier Choice for Women with Breast Cancer

Brandel France de Bravo, MPH and Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

Experts have long advised that lumpectomy patients live as long as mastectomy patients.  But the latest research, based on hundreds of thousands of women, indicates that women with DCIS or early-stage breast cancer are more likely to live longer, healthier lives if they choose less radical surgery. And their quality of life will also be better.

Five enormous studies indicate that lumpectomy patients live longer.

In a 2021 study of almost 49,000 Swedish women followed for 6 years after surgery for early-stage breast cancer, the women who underwent lumpectomy with radiation therapy lived longer on average than those who underwent mastectomy with or without radiation therapy. The benefit of lumpectomy was true when diagnosis, other medical problems, social class, and other demographic factors were statistically controlled. [1]

In a study of almost half a million women with breast cancer in one breast, Harvard cancer surgeon Dr Mehra Golshan reported in 2016 that those undergoing double mastectomies did not live longer than women undergoing a mastectomy in only one breast.[2] On average, women who underwent a lumpectomy instead of mastectomy lived longer than women undergoing either a single or double mastectomy for cancer in only one breast.

Similarly, a study of more than 37,000 women, also published in 2016, women with early-stage breast cancer who underwent lumpectomy with radiation were more likely to be alive 10 years later, compared to women who underwent mastectomies.[3] They were also less likely to have died of breast cancer or of other causes. This was true even when age and factors that could influence survival were taken into account.

Dr. Shelly Hwang and her colleagues found similar results in a 2013 study of more than 112,000 California women who had lumpectomies to remove their early-stage breast cancer were more likely to be alive and free of breast cancer 5 years after surgery than women who had mastectomies.[4] The women had been diagnosed between 1990 and 2004 with either Stage 1 or 2 breast cancer. All of them had either a lumpectomy with radiation or a mastectomy. After surgery, their health was monitored for an average of 9 years (the women were all studied for 5-14 years). The women who had a lumpectomy and radiation tended to live longer than the women who had mastectomies, when controlling for age at diagnosis, race, income, education levels, tumor grade or the number of lymph nodes with cancer. Lumpectomy with radiation was especially effective for women who were 50 years and older with hormone-receptor positive tumors: they were 19% less likely to die of any cause during the study than women just like them who had mastectomies. Perhaps more surprising, they were 13% less likely to die of breast cancer than women just like them who had mastectomies.

In a study published in 2014, Dr Allison Kurian and her colleagues at Stanford studied 189,734 California patients diagnosed from 1998 to 2011 with early-stage breast cancer in one breast, ranging from Stage 0 (DCIS) to Stage 3.[5] The study showed that the percentage of women having both breasts when only one breast had cancer (called bilateral mastectomies) increased dramatically, but there was no advantage to that more radical approach.  Instead, the women who underwent lumpectomies (removing only the cancer, not the entire breast) lived longer and were more likely to be alive 10 years after diagnosis compared to women undergoing a mastectomy.  Women who had both breasts surgically removed did not live longer than those undergoing a mastectomy on one breast.

A study of 560 young women with early-stage (stage 0-3) breast cancer published in JAMA Surgery in 2021, found that women who underwent lumpectomies had a better quality of life than women who underwent mastectomies, regardless of whether they had reconstructive surgery. The women were all 40 years old or younger when they were diagnosed, and their quality of life was evaluated an average of 5-6 years after surgery.  Women’s quality of life tended to be lowest for women who had undergone mastectomy with radiation therapy. [6]

Compared to women in other countries, women in the U.S. who are diagnosed with early-stage breast cancer are more likely to remove both breasts even if only one has cancer. It is not known why bilateral mastectomy provides no medical advantage, but a study of more than 4,000 cancer patients by Dr. Fahima Osman at the University of Toronto indicates that having a healthy breast removed in addition to the breast with cancer increases the chances of medical complications.[7] Removing the healthy breast (“contralateral breast”) doubled the chances of having wound complications in the first month after surgery: from about 3% for women who had only the breast with cancer removed to about 6% for women who also had the healthy breast removed. About 4% of women who had a single mastectomy experienced some kind of complication (not necessarily wound-related) in the 30 days after surgery, compared to 8% of women who had both breasts removed. The risk of cancer in that healthy breast was already less than 1% per year unless the woman has a BRCA gene or some other very high risk factor.[7] Hormone pills such as tamoxifen or aromatase inhibitors can further reduce that already low risk.

The Bottom Line: These enormous studies of women in the U.S. and other countries make it clear that women with DCIS or early-stage breast cancer (stages 1-3) should undergo surgery to remove only the DCIS lesion or the cancer, not the entire breast. The women who undergo lumpectomy with radiation usually live longer than those who undergo single mastectomy or bilateral mastectomy, with or without radiation. The one study of young women with breast cancer found that although many undergo mastectomy with reconstruction, their quality of life would be better if they underwent lumpectomy instead. In addition, mastectomy patients who have breast implants are more likely to kill themselves compared to mastectomy patients without implants. Unfortunately, the fear of breast cancer and desire to “get rid of the problem” has resulted in too many women undergoing medically unnecessary mastectomies that do more harm than good. Physicians and breast cancer advocacy groups need to make sure that patients understand why lumpectomy with radiation is a better idea.

For a free booklet on treatment options for DCIS, click here.  For a free booklet on treatment options for early-stage breast cancer, click here.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References 

  1. de Boniface J, Szulkin R, Johansson ALV. Survival After Breast Conservation vs Mastectomy Adjusted for Comorbidity and Socioeconomic Status: A Swedish National 6-Year Follow-up of 48 986 Women. JAMA Surg. 2021;156(7):628–637. doi:10.1001/jamasurg.2021.1438
  2. Wong, S., Freedman, R., Sagara, Y., Aydogan, F., Barry, W., & Golshan, M. Growing Use of Contralateral Prophylactic Mastectomy Despite no Improvement in Long-term Survival for Invasive Breast Cancer. Annals of Surgery. 2016 March; doi:10.1097/SLA.0000000000001698
  3. Marissa C. van Maaren, et al, “10 year survival after breast-conserving surgery plus radiotherapy compared with mastectomy in early breast cancer in the Netherlands: a population-based study”. Lancet Oncol. 2016 Aug; 17(8): 1158–1170. Published online 2016 Jun 22. doi: 10.1016/S1470-2045(16)30067-5
  4. Hwang ES, et al “Survival after lumpectomy and mastectomy for early stage invasive breast cancer: The effect of age and hormone receptor status” Cancer2013 April 1; 119(7); DOI: 10.1002/cncr.27795.
  5. Kurian, Allison W., Daphne Y. Lichtensztajn, Theresa H. M. Keegan, David O. Nelson, Christina A. Clarke, and Scarlett L. Gomez. “Use of and Mortality After Bilateral Mastectomy Compared With Other Surgical Treatments for Breast Cancer in California, 1998-2011.” The Journal of the American Medical Association2014; 312(9): 902-914. DOI:10.1001/jama.2014.10707
  6. Dominici L, Hu J, Zheng Y, et al. Association of Local Therapy With Quality-of-Life Outcomes in Young Women With Breast Cancer. JAMA Surg. Published online September 01, 2021. doi:10.1001/jamasurg.2021.3758
  7. Osman, Fahima, et al “Increased postoperative complications in bilateral mastectomy patients compared to unilateral mastectomy: an analysis of the NSQIP database.” 2013 Oct; 20(10): 3212–3217. Published online 2013 Jul 12. doi: 10.1245/s10434-013-3116-1
  8. National Cancer Institute. Breast Cancer Treatment (PDQ®). http://www.cancer.gov/cancertopics/pdq/treatment/breast/healthprofessional/page1