US FDA to update breast implant labelling for cancer risk
This article was originally published in RAJ Devices
The US Food and Drug Administration has warned that saline and silicone gel-filled breast implants could potentially be associated with a risk of a very rare type of cancer, called anaplastic large cell lymphoma (ALCL)1.
To ensure that patients receiving breast implants are informed of the possible risk, the agency said it would be working with breast implant manufacturers in the coming months to update their product labelling materials for patients and healthcare professionals. Healthcare professionals have been asked to report any confirmed ALCL cases with breast implants
The FDA notification is based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists and breast implant manufacturers2. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants. The FDA noted that an estimated five to ten million women worldwide have breast implants.
The agency said it intends to provide an update on its review of silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the US, adverse event reports submitted to the FDA and a review of the scientific literature on these products.
William Maisel, chief scientist and deputy director for science at the FDA's Center for Devices and Radiological Health, said the agency needs more data on the issue and is already collaborating with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, "which should help us better understand the development of ALCL in women with breast implants".
While the details of this collaboration are being developed, the FDA is advising healthcare professionals to test breast implant patients with suspected ALCL and to submit findings of confirmed cases to the agency.
In total, the FDA is aware of about 60 cases of ALCL in women with breast implants worldwide. The agency, however, warns that this number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports.
FDA review of scientific literature made public
The FDA's literature review revealed that most cases of ALCL were diagnosed when patients sought medical treatment for implant-related symptoms, such as pain, lumps, etc, that developed after their initial surgical sites were fully healed.
These symptoms were due to collection of fluid, hardening of breast area around the implant or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the ALCL diagnosis, the agency explains.
In light of these findings, the FDA believes that women with breast implants may have a very low but increased risk of developing ALCL adjacent to the breast implant. Currently, the agency is not recommending women with breast implants to change their routine medical care and follow-up. Women considering breast implant surgery are being asked to discuss the risks and benefits with their healthcare provider.
In a Q&A document accompanying the literature review, the FDA clarifies that while some scientists have suggested that the type of implant fill may be a risk factor for ALCL, this has not been evaluated in a large, well-designed epidemiologic study. To date, the agency says, there have not been sufficient data to determine whether ALCL may be found more or less frequently in women with silicone-filled breast implants compared to women with saline-filled breast implants.
Australia against removal of implants
Meanwhile, Australia's Therapeutic Goods Administration has issued a statement in reaction to the FDA alert3. At present, the TGA is not recommending prophylactic breast implant removal in patients without symptoms or other abnormality.
Although there are no equivalent data, the TGA believes the rate of ALCL occurrence in Australia is likely to be the same as in the US, where approximately three in 100 million women are diagnosed with ALCL in the breast every year.
Because the risk of ALCL appears very small, the TGA believes that the totality of the evidence presently available continues to support a reasonable assurance that approved breast implants are safe and effective, when used as labelled.
The UK Medicines and Healthcare products Regulatory Agency recently carried out a review on the association of cancers for women with breast implants and concluded that there was insufficient evidence to indicate any association, a spokesperson told Regulatory Affairs Medtech.
Additionally, the MHRA has worked with the Cancer Registry and it could find no evidence for any association. The agency is currently monitoring the situation for any associations of breast implants with cancers and will review any new evidence which comes to light.
References
1. FDA press release, 26 January 2011, www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm241090.htm
2. FDA, Anaplastic Large Cell Lymphoma, 26 January 2011, www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm
3. TGA press release, 27 January 2011, www.tga.gov.au/safety/alerts-device-breast-implants-110127.htm