The decision to obtain breast implants is a personal choice that comes with risks. You must trust that your physician is aware of these risks and informs you of them prior to your consent for the surgery. You also have to trust that the company that makes the breast implants is just as concerned about your safety as you are. Is this truly the case? Did you know about the risk of developing a rare form of blood cancer before you signed the consent to allow the physician to surgically place the breast implant? Did the manufacturer properly educate you and your physician on the risks? Did your team of health care professionals ensure you were fully informed and aware of all the risks prior to having you sign the consent form? If you answered no to those questions, the trusted medical malpractice attorneys at Marrone Law Firm want to help you.
In 2016, the World Health Organization (WHO) recognized a direct link between breast implants and a rare form of T-cell lymphoma known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The WHO’s position aligns with a statement by the Food and Drug Administration (FDA) from 2011 as well. This agreement is a positive step forward in the recognition of BIA-ALCL as a risk and side effect of certain types of breast implants, and will help to hold physicians accountable for possible medical malpractice and manufacturers accountable for product liability.
What is Breast Implant-Associated Anaplastic Large Cell Lymphoma?
BAI-ALCL was first described in 1997. However, it has taken many years for the medical community to come to the consensus that there is a direct link between breast implants and this rare blood cancer. The difficulty comes from issues of under-reporting by manufacturers of breast implants and physicians. This under-reporting is thought to be related to the amount of time that has typically passed between the implantation and the diagnosis of BIA-ALCL.
BIA-ALCL is a cancer of the immune cells in the blood. It is not breast cancer or cancer of the breast tissue. It is not detectable during breast self-exams or annual mammograms. Instead, it is a rare type of non-Hodgkin’s Lymphoma that usually presents itself as a late onset seroma, or a collection of fluid around a breast implant that has been surgically placed more than one year prior to the onset of symptoms. Women with breast implants have a very low, but increased risk of developing BIA-ALCL when compared to women who have never had breast implants, according the FDA. BIA-ALCL is so rare, in fact, that it took time to find the link between the breast implant and anaplastic large cell lymphoma.
What Causes BIA-ALCL?
Since the initial statement from the FDA in 2011, much research has been completed to identify risk factors associated with BIA-ALCL. As of February 1, 2017, the FDA reports having received 359 Medical Device Reports (MDR) detailing BIA-ALCL in women with breast implants. The information is not always complete, making it difficult to come to a true understanding of the link between breast implants and ALCL.
In these 359 MDRs, the severity of illness ranges from death to removal of the breast implant with no continued lifelong risks. In 231 of the reports, the surface of the breast implant was reported and showed significance. Out of the 231 reports, 203, or 88%, were implants with a textured surface. Many physicians will chose textured implants due to their likelihood of attaching to the natural capsule formed by the body after implantation, holding the implant in the desired look over time. It is thought that the texture helps the implant to stay in place and look natural, even for women who have a very active lifestyle.
However, the data does not show an increase in risk of developing BIA-ALCL based on the fill type of the breast implant, such as silicone gel versus saline. The information gathered in these Medical Device Reports points to a likely link between breast implants with textured surfaces and the development of BIA-ALCL. According to Clemens, there is current investigation into the association of bacteria and biofilm that lines the outside of the textured implant itself. This association may play a role in the cause of the disease. More information is being collected through a collaborative with the American Society of Plastic Surgeons (ASPS) and Plastic Surgery Foundation (PSF).
What Are the Signs and Symptoms?
In the 2016 revision of the World Health Organization classification of lymphoid neoplasms, the authors found that the median time from the date of implant to the date of being diagnosed with BIA-ALCL is ten years. There have been no reported cases of symptoms presenting less than one year after the implant was placed. Common signs and symptoms reported include, but are not limited to the following:
- Changes to the look or feel of the implant
- Pain around the implant
- Swelling around the implant
- Asymmetry of the implant
How is BIA-ALCL Diagnosed?
Many women are thought to have a benign delayed seroma, which is the collection of serous fluid that spontaneously occurs around the breast implant more than one year after implantation. These women will often have a true malignant effusion due to the increased protein and cellularity of the fluid. The physician may perform surgery to remove this fluid and subsequently discover the diseased fluid and tissue around the breast implant.
If the physician suspects BIA-ALCL, an ultrasound or other imaging, such as a Computed Tomography (CT or CAT) scan or Magnetic Resonance Imaging (MRI), will be performed to look at the implant and surrounding area. If your physician feels that BIA-ALCL is a risk, a sample of fluid will be taken from around the breast implant. This fluid will then be examined for the presence of T-lymphocytes and proteins common with BIA-ALCL.
Due to the limited amount of information available, there is not one accepted treatment plan for BIA-ALCL at this time. However, BIA-ALCL is a highly curable disease. Most physicians agree that removal of the breast implant and a thorough evaluation of the tissue and lymph nodes located near the breast is a necessary measure. If the ultrasound or other diagnostic tests performed revealed a mass that protrudes into the breast tissue, the mass and all involved tissue will need to be removed. If the surgeon is not certain that there were clear borders and all of the diseased tissue has been removed, chemotherapy, radiation therapy or a combination of both may be prescribed. The FDA and WHO recommend a multi-disciplinary healthcare team, including a lymphoma oncologist, to ensure that all cancerous tissue is removed or treated to decrease the likelihood of recurrence.
Medical Malpractice and Product Liability
Medical malpractice is usually thought to require a wrong decision by a healthcare professional. However, all patients are entitled to be fully informed of all risks prior to signing a consent form for any treatment. This holds your physician accountable to answer all of your questions and ensure you are aware of all potential benefits, risks and alternatives prior to agreeing to any treatment.
Product liability refers to the liability of a product manufacturer or seller who allows a defective product to be sold to consumers. The product does not have to be bought directly by you, the consumer, if there is a third party who chooses the product for you, such as the physician. The manufacturer is also responsible for educating the physician of possible defects or issues arising from use of the product.
If you been diagnosed with ALCL after a breast implant surgery, you have rights. It is imperative you speak with a qualified attorney to discuss the issues you have experienced since your breast implant surgery. The Marrone Law Firm has a team of skilled medical malpractice attorneys ready to provide the legal support you need during this challenging time. Take a step toward getting the representation you need for your future by contacting us today to schedule a free consultation.
- Swerdlow, S. H., Campo, E., Pileri, S. A., Harris, N. L., Stein, H., Siebert, R., . . . Jaffe, E. S. (2016). The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood, 01(643569). doi:doi.org/10.1182/blood-2016-01-643569
- Jewell M., Spear S.L., Oefelein M.G., Adams, W.P. Jr. (2011). Anaplastic large T-cell lymphoma and breast implants: a review of the literature. Plastic Reconstructive Surgery, 128(3):651-61.
- Clemens, M.W., Nava, M.B., Rocco, N., Miranda, R.N. (2017). Understanding rare ad verse sequelae of breast implants: anaplastic large-cell lymphoma, late seromas and double capsules. Gland Surgery, 6(2).
- Center for Devices and Radiological Health. (2017, April 14). Breast Implants – Risks of Breast Implants. Retrieved June 08, 2017, from https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm064106.htm
- US Food and Drug Administration Home Page. (June 08). Retrieved June 08, 2017, from https://www.fda.gov
- American Society of Plastic Surgeons. (2017). Retrieved June 08, 2017, from https://www.plasticsurgery.org
- The Plastic Surgery Foundation. (2017). Retrieved June 8, 2017, from https://www.thepsf.org
Veteran litigator and celebrated television legal analyst, Joseph M. Marrone, Esquire is a leader in the intersecting world of medical malpractice and products liability. He can be reached at 215-732-6700 or 866-732-6700.
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