What the FDA Recommends About Implant Removal
The FDA's position is that asymptomatic women with recalled Allergan BIOCELL implants do not need to have their implants removed prophylactically. The FDA's reasoning is that the absolute risk of BIA-ALCL, while elevated compared to other implants, remains low in absolute terms — and explant surgery itself carries surgical risks (anesthesia, infection, scarring, and the psychological impact of losing reconstruction results). The FDA recommends that women with BIOCELL implants monitor with regular follow-up visits with their plastic surgeon and report any new symptoms immediately. However, women with symptoms consistent with BIA-ALCL — particularly late-onset seroma, breast swelling, or a new lump — should seek prompt medical evaluation and not delay out of reluctance to undergo surgery.
Explant Surgery Costs and Insurance Coverage
Explant surgery for breast implants typically costs $3,000 to $10,000 out of pocket depending on whether implant replacement is performed, the need for capsulectomy, anesthesia and facility fees, and geographic location. Insurance coverage for recall-driven explantation is inconsistent: some insurers cover it as medically necessary when documented with a BIA-ALCL symptom or diagnosis; others classify cosmetic explant surgery as elective and deny coverage. Post-mastectomy reconstruction patients often have stronger insurance coverage arguments under the Women's Health and Cancer Rights Act (WHCRA). Out-of-pocket explant surgery costs related to the Allergan recall are recoverable as economic damages in MDL 2921 claims, in addition to non-economic damages for distress and the disruption of undergoing an unplanned surgical procedure.
En Bloc Capsulectomy — What to Request If You Are Removing BIOCELL Implants
If you are proceeding with explant surgery for Allergan BIOCELL implants — whether due to BIA-ALCL symptoms or personal decision — the FDA and ASPS recommend requesting en bloc capsulectomy: removal of the implant together with the entire surrounding capsule as one intact specimen. This approach is important if BIA-ALCL is suspected or present, as it ensures complete removal of any potentially malignant capsule tissue and allows the pathologist to evaluate the intact specimen. Even without a BIA-ALCL diagnosis, en bloc removal and pathological examination of the capsule can identify early-stage disease (Stage IA in seroma fluid or on the inner capsule surface) that might be missed with simple implant removal. Request that the explanted implant and capsule be sent to pathology for analysis. Keep copies of all surgical and pathology reports — these are critical evidence for any legal claim.
Frequently Asked Questions
Related Pages
BIA-ALCL is not breast cancer — it is a T-cell lymphoma of the immune system that develops in the fluid or capsule surrounding Allergan BIOCELL textured implants. It is often curable when caught early, but advanced stages require chemotherapy and carry serious health consequences.
Learn moreBIA-ALCL staging — from Stage IA (confined to seroma fluid) through Stage IV (distant metastases) — is the single most important factor in determining the value of an Allergan breast implant lawsuit. Early-stage cases are curable; advanced stages require chemotherapy and carry worse prognosis and significantly higher compensation.
Learn moreThe July 24, 2019 Allergan BIOCELL recall was the largest breast implant recall in FDA history. It covered 33+ product lines after the FDA determined BIOCELL recipients faced a 6x elevated risk of BIA-ALCL lymphoma. French regulators had recalled the same product a year earlier in 2018.
Learn moreBreast implant illness (BII) is a constellation of systemic symptoms — fatigue, brain fog, joint pain, hair loss — reported by implant patients. Unlike BIA-ALCL, BII is not yet a formally recognized diagnosis, but BII plaintiffs with Allergan BIOCELL implants are included in MDL 2921 litigation.
Learn moreThe Allergan Natrelle 410 Highly Cohesive Anatomically Shaped implant was the most widely used recalled product and is at the center of MDL 2921. McGhan textured implants — an earlier Allergan brand — are also covered by the July 2019 recall. If you received either product, you may have a claim.
Learn moreWomen who received Allergan BIOCELL textured implants or tissue expanders as part of post-mastectomy breast reconstruction after breast cancer are a distinct and especially sympathetic plaintiff class in MDL 2921. They fought breast cancer once — and Allergan's recalled product put them at risk of a second cancer.
Learn moreNo global Allergan BIOCELL settlement has been announced as of February 2026. The October 2026 bellwether trial will drive settlement negotiations. Based on comparable medical device MDLs, BIA-ALCL Stage IA cases may settle in the $50,000–$300,000 range; Stage IV cases may command $1,000,000–$3,000,000 or more.
Learn moreThe statute of limitations for Allergan BIOCELL claims is typically 2 to 3 years from discovery — meaning from BIA-ALCL diagnosis, not from implant placement or recall date. Discovery rule protections apply in most states. Consult an attorney immediately — deadlines are strict and MDL tolling is not automatic.
Learn moreYou may qualify if you received Allergan BIOCELL textured implants (for augmentation or reconstruction), were diagnosed with BIA-ALCL, or had your implants removed due to the recall. You do not need a cancer diagnosis to file. Implants already removed do not disqualify you.
Learn moreAllergan Breast Implant Lawsuit Lawsuit
Allergan (now owned by AbbVie) manufactured BIOCELL textured breast implants — including the widely used Natrelle 410 — that were found to cause breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare but serious T-cell lymphoma of the immune system. The FDA determined that women with Allergan BIOCELL implants were approximately six times more likely to develop BIA-ALCL than women with implants from other manufacturers. On July 24, 2019, Allergan initiated a worldwide recall of all BIOCELL textured breast implants and tissue expanders. As of June 2023, the FDA had received 1,264 BIA-ALCL reports globally, with 1,079 — representing 85% of all cases — involving Allergan implants. Sixty-three deaths have been reported, with 37 linked to Allergan products. MDL 2921, In re Allergan BIOCELL Textured Breast Implant Products Liability Litigation, is pending before Judge Michael Martinotti in the District of New Jersey with approximately 1,400 cases. The first bellwether trial is scheduled for October 2026. Women who received Allergan BIOCELL textured implants, were diagnosed with BIA-ALCL, or underwent implant removal due to the recall may have viable legal claims.
View full case overview