If you have textured breast implants, the Allergan and McGhan textured breast implant recall can be alarming. Do not panic, but educate yourself. Both saline and silicone TEXTURED breast implants were recalled for their association with Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
If you do not know what type of implants you have, again don’t panic! Take action by contacting your implanting surgeon. Because surgeons are not required to keep your records forever, contact them as soon as possible. Ask if they registered your implants with the manufacturer and get a copy of all warranty and device information.
If you have recalled textured breast implants (SILICONE OR SALINE) from Allergan or McGhan, don’t panic! Keep reading, be aware, stay informed, and be empowered to take charge of your own health. You may wish to begin researching breast explant options, because waiting lists for qualified surgeons are quite long. You may wish to discuss your case with a BIA-ALCL attorney, as well, to ensure that proper procedures are followed.
FDA Textured Breast Implant Recall
On July 24, 2019, the United States Food and Drug Administration (FDA) recommended that Allergan issue a voluntary TEXTURED breast implant recall. Textured breast implants have been associated with an increased risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The recall also includes textured tissue expanders used to create space for a breast implant during reconstruction. Textured implants from McGhan Medical are also included in the recall.
BIA-ALCL is a relatively rare type of cancer affecting a small percentage of all women with breast implants. Because many women have breast implants with a smooth surface, which have NOT been linked to BIA-ALCL, the overall percentage of all women with implants diagnosed with BIA-ALCL is small. If you have textured implants, your risk of developing BIA-ALCL, while still small, is higher than the overall rate for all women with implants.
A list of devices recalled in the United States from the FDA, can be found here (FDA, 2019c).
FDA Breast Implant Removal Recommendations
From the U.S. FDA website, “For patients who have no symptoms, removal of these or other types of breast implants is not recommended, due to the low risk of developing BIA-ALCL. However, if you have any questions, talk to your health care provider” (FDA, 2019b). There are surgical risks to explant surgery. At the time of this recommendation, the FDA felt that the risks of surgery were greater than the risk of BIA-ALCL, for women without symptoms.
When did they know about the risks of Textured Breast Implants?
The 2011 FDA Update on the Safety of Silicone Gel-Filled Breast Implants stated that “Women with breast implants may be more likely to be diagnosed with anaplastic large cell lymphoma (ALCL),” (Drugwatch, 2019b, FDA, 2011).
Lawsuits against Allergan indicate that the company may have been aware of the risk years earlier, in the 1990’s (Drugwatch, 2019a).
In March, 2019, the FDA heard two days of testimony from experts (link to FDA testimony video) in the breast implant field. But in May, 2019, declined to ask for a recall due to the low risk of BIA-ALCL. In July, 2019, the FDA took the unusual action of asking Allergan to recall textured breast implants and tissue expanders after additional data was reviewed (Drugwatch, 2019c). Typically, companies initiate a recall without the FDA forcing the issue.
Regulatory agencies in other countries had previously recommended this action. France’s National Agency for Safety of Medicines and Health Products (ANSM) was the first to issue a ban. Allergan stopped selling textured breast implants in Europe in December, 2018. Allergan announced that it would recall and stop the sale of textured Biocell breast implants in Canada in May, 2019 (Physician’s Weekly, 2019).
Breast Implant Recall Notices
According to the FDA, Allergan mailed recall notices to women with the recalled breast implants in 3 separate notification campaigns (FDA 2019b). I had a nurse from a plastic surgeon’s office tell me that because I did not receive a letter, my implants were not recalled.
However, not all surgeons register breast implants when they are implanted. Women change addresses regularly. And surgeons are not required to keep medical records forever. Not receiving a letter does NOT mean that your implants are not recalled. Find your medical device registration card- if you were given one. If not, call your implanting surgeon’s office and request a complete copy of your medical record.
Breast Implant Recalls in the UK, Canada, and Australia
In the United Kingdom, the UK.gov website shares guidance for patients and physicians (gov.UK, 2019). The UK government previously issued 3 Medical Device Alerts regarding the increased risk of BIA-ALCL in 2011, updated in 2014, and in 2019.
Allergan’s Financial Impact from Breast Implant Recall
Quoting financial analysis in the UK, Reuters speculated that a direct financial impact from the recall would be negligible for Allergan, which announced its sale to AbbVie, Inc. for $63 billion prior to the FDA recall (Reuters, 2019, Wall Street Journal, 2019).
References
Drugwatch. (2019a). Allergan Breast Implant Lawsuits. Retrieved from https://www.drugwatch.com/allergan-breast-implants/lawsuits/
Drugwatch. (2019b). Allergan breast implant recalls. Retrieved from https://www.drugwatch.com/allergan-breast-implants/recalls/
Drugwatch. (2019c). Allergan cites rare cancer as reason for breast implant recall. Retrieved from https://www.drugwatch.com/news/2019/07/30/allergan-cites-rare-cancer-breast-implant-recall/
Gov.UK (2019). Breast implants and Anaplastic Large Cell Lymphoma (ALCL): Information for clinicians and patients. Retrieved January 22, 2020, from https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl#history
Physician’s Weekly. (2019). Allergan to recall textured breast implants in Canada. Retrieved from https://www.physiciansweekly.com/allergan-to-recall-textured/
Reuters. (2019, July 24). Allergan recalls textured breast implants worldwide. Retrieved from https://uk.reuters.com/article/us-allergan-recall/allergan-recalls-textured-breast-implants-worldwide-idUKKCN1UJ1N9
U.S. Food and Drug Administration (FDA). (2019a). Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL Cancer. Retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer
U.S. Food and Drug Administration (FDA). (2019b). Medical device recalls: Allergan. Retrieved 2020, January 22, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=&productdescriptiontxt=&productcode=&IVDProducts=&rootCauseText=&recallstatus=¢erclassificationtypetext=&recallnumber=&postdatefrom=09%2F10%2F2019&postdateto=09%2F12%2F2019&productshortreasontxt=&firmlegalnam=Allergan&PMA_510K_Num=&pnumber=&knumber=&PAGENUM=500
U.S. Food and Drug Administration (FDA). (2019c). The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue#list
Wall Street Journal. (2019, June 25). AbbVie Strikes Deal to Acquire Allergan for About $63 Billion: Drugmakers agree to one of the biggest mergers in the health sector this year. Retrieved from https://www.wsj.com/articles/abbvie-nears-deal-to-buy-allergan-for-more-than-60-billion-11561458504